Latin name: JEANINE
ATX code: G03A A16
Active substance: ethinylestradiol, dienogest
Manufacturer: BAYER PHARMA (Germany)
Vacation from the pharmacy: On prescription
Storage conditions: in the dark, at t up to 25 °C
Best before date: 3 years

Jeanine is one of the most effective means of modern oral contraception.

Composition and dosage form

One dragee Jeanine contains components:

• Active: 30 mcg ethinyl estradiol, 2 mg dienogest
• Additional: lactose (in the form of monohydrate), potato starch, gelatin, E572, talc, sucrose, glucose syrup, macrogol-35000, calcium carbonate, povidone K-25, E171, palm wax.

Contraceptive drugs are available in the form of dragees - small pills under a white coating. The product is packaged in blisters of 21 pieces. In a pack of cardboard - 1 or 3 plates, an accompanying annotation.

Medicinal properties

The contraceptive effect of Jeanine is due to the directed action of two components - ethinyl estradiol and dienoget. The processes launched by them cause multiple biochemical reactions, the most significant among them are the blocking of ovulation, changes in the structure and composition of the cervical secret. As a result of the influence of OK, spermatozoa lose the ability to penetrate into the uterine cavity.

When maintaining all the conditions of admission, the value of the Pearl index is less than 1. If the pills are taken with gaps or there are other violations, then the value increases.

Due to the progestogenic properties of dienogest, OK has an antiandrogenic effect, which has been confirmed by numerous studies and observations. In addition to the contraceptive effect, the substance simultaneously favorably affects the characteristics of the blood, increasing the content of dense lipoproteins.

Patients taking Janine noted that as a result of OK, MC returned to normal, the intensity of PMS decreased or disappeared completely, the duration or intensity of menstruation was reduced, which sharply reduced the risk of IDA. In addition, there is medical evidence that the contraceptive is able to prevent the occurrence of ovarian and/or endometrial cancer.

• Dienogest

Belongs to the group of nortestosterone derivatives, has pronounced antiandrogenic properties, has a strong progestogenic effect. After penetration into the uterine cavity, it acts on the nerve endings of the endometrium, suppressing trophic effects. With prolonged use, it contributes to the attenuation of endometrioid foci, reduces the increased synthesis of estrogens by the ovaries.

The substance after taking the dragee is quickly absorbed from the gastrointestinal tract, peak concentrations are formed after 2.5-3 hours. It has a high bioavailability - almost 96%. Almost completely metabolized.

It is excreted from the body mainly with urine, a small amount is excreted with bile. The duration of the process ranges from 8 to 10 hours.

• Ethinylestradiol

The substance is a synthetic analogue of the hormone estrogen, therefore it has almost the same effect. It activates the formation of the uterus, tubes and secondary signs of sex, affects the state of the endometrium, increases the excitability of the uterus. In addition, the artificial compound is involved in nitrogen metabolism, reduces lipid content, and regulates the presence of cholesterol. In large doses, it can retain fluid in the body, contributing to swelling.

After oral administration, it is rapidly and completely absorbed. The highest concentrations are formed within 1-4 hours. It is transformed with the formation of metabolites in the small intestine and liver. It is excreted from the body in two stages along with urine and bile.

Mode of application

Take Jeanine instructions for use prescribes one tablet per day, at the same time and in accordance with the calendar index on the blister. Dragee is undesirable to bite or break - you need to drink only whole with a small amount of water. After the contents of the blister are over, a week-long break is observed, during which menstrual-like bleeding should occur. It usually occurs 2-3 days after taking the last pill. After a week, they resume taking OK from a new blister.

When to start drinking OK

If before the appointment of Janine, the patient was not protected by other OKs or there was a break in the reception for at least a month, then the first dragee should be drunk on the 1st day of the MC. If this is done later - between the 2nd and 5th day, then it will take a week to additionally protect yourself with condoms.

In the case of other OKs before Jeanine, they drink the dragee the next day after taking the previous active tablet (or placebo). In this case, a break of more than a week should not be allowed.

If a woman was protected with a TD patch or vaginal ring, then the pills are drunk on the day the remedy is withdrawn. In the case of injections - on the day of the next injection.

After stopping the course of drugs with gestagens, start taking pills on the next day after taking the pill from the previous OK, on ​​the day the uterine contraceptive is removed or on the day of the next hormonal injection. In this case, in all cases, additional protection by barrier means will be required.

After a miscarriage or abortion in the first 3 months of pregnancy, Jeanine is taken immediately after the interruption of gestation.

If the pregnancy ended at the 2nd term, then before taking Jeanine, it is necessary to withstand from 21 to 28 days. A later appointment should be accompanied by the use of condoms. If an unprotected PA occurred before taking the dragee, then you will need to make sure that there is no pregnancy or postpone the course until the onset of menstruation.

What to do when skipping OK

If for some reason a woman could not drink the pills on time, and the delay was less than 12 hours, then there is nothing to worry about, since the content of substances in the blood, although it will decrease somewhat, the contraceptive effect will remain. She'll just have to take the pills as soon as the opportunity presents itself.

If more than 12 hours are missed, the contraceptive concentration of the medication will decrease more strongly, and in order to restore the normal intake schedule, the woman can use one of the following methods:

• Skip the 1st week of the course: take the forgotten pill, and the next - according to the schedule. If the methods coincide - drink two pieces at once and then use additional protective equipment for a week.
• Pass in the 2nd week of the course: drink the missed one, and the next - according to the schedule, if the receptions coincide - two pieces at once. If in the first 7 days there were no violations in the course, then there is no need for condoms. In case of the same forgetfulness, use them for a week.
• Skip on the 3rd week of the course: take a forgotten pill and another at the usual hours. After the end of one blister, start a new one without observing any intervals. Withdrawal bleeding should not occur, but may present as "spotting" or breakthrough bleeding.

Another option for correcting the situation is also possible: do not replenish the intake of dragees, but take a 7-day break, and after it ends, proceed to a new package of OK.

A decrease in the concentration of substances can occur due to vomiting or diarrhea in the first 4 hours after ingestion. In this case, you will need to drink another dragee.

• How to postpone or reschedule the day of the MC

To transfer the period to another day, you do not need to observe a break, but immediately start taking a new blister and drink the number of pills that you need, up to the end. Then incubated for 7 days without tablets before taking from the next pack.

To change the beginning of the MC to a different date, you need to shorten the break by the desired number of days.

Reception features

Teenagers should only take Janine after their first bleeding.

Elderly women in menopause do not require OK.

If the patient has problems with the liver, then OK can be taken only after the condition is completely stabilized.

The nuances of admission in women suffering from kidney pathologies have not been studied. Therefore, it is better to check with the gynecologist whether or not you can drink OK and how to take Jeanine correctly.

Jeanine therapy for endometriosis

Thanks to the active substances contained, the contraceptive medication can be used in the treatment of endometrial pathology. A significant advantage of OK is that it can be taken in various forms of the disease: both in the early stages and in advanced cases. Depending on the indications, the most effective option is developed for each patient. On average, treatment with the drug takes about 63 days, that is, you need to drink 3 blisters of 21 tablets.

Scheme of application - one tablet per day strictly at one hour. After completion of the reception, a seven-day break is observed for menstrual-like bleeding.

After analyzing the results of therapy, the gynecologist decides whether to continue taking OK. But usually one course of Janine therapy for endometriosis is enough to eliminate excess tissue growth.

If the pathology is more advanced, then the course of therapy may take a longer time - 84 days.

During pregnancy and lactation

Average price: No. 21 - 1005 rubles, No. 63 - 2480 rubles.

The drug should not be used during childbearing and breastfeeding. If during the course it turns out that the woman is pregnant, you should immediately stop taking the medication in order to avoid unforeseen consequences. but so far, various epidemiological studies have not confirmed any pathologies in the development of children born from women who took Janine hormonal tablets in the early stages of pregnancy.

Lactating women should not use the medication, as the active substances can adversely affect the production and volume of milk. In addition, a small amount of sex hormones and their metabolites can be excreted into milk. If a woman needs to take OK, lactation should be abandoned for the duration of the course of tablets.

Contraindications

Jeanine birth control pills should not be taken if at least one of the following factors is present. If during the course such conditions or pathologies arose for the first time, then hormonal OK should be immediately canceled. The drug is prohibited for:

• Thrombosis or thromboembolism at the time of prescription or in the past
• Diseases or conditions that increase the risk of thrombosis (currently or in the past)
• Congenital or acquired tendency to thrombosis
• Existing high risk of vein/arterial thrombosis
• Migraines with associated neurological manifestations at the time of appointment or in the past
• DM with damage to the vascular system
• Pancreatitis with severely elevated plasma triglycerides (current and past)
• Renal failure, severe organ damage (use is possible only after
• Neoplasms of the liver (benign and malignant) at the time of Zhanine's appointment or existing in the past
• Confirmed by the examination of benign hormone-dependent neoplasms and the assumption of their presence
• Vaginal bleeding of unspecified origin
• Confirmed or suspected pregnancy, GV
• Individual hypersensitivity to Janine components
• Congenital lactose intolerance, deficiency in the body of lactase, sucrase, GG malabsorption syndrome (due to lactose and sucrose in the composition).

Use OK should be used with caution if a woman has:

• Predisposition, threats of risk of pulmonary embolism, thrombosis and conditions preceding them
• Tobacco smoking
• Overweight, obesity
• Hypertension, amenable to correction by drugs
• Migraine without focal symptoms
• Congenital tendency to thrombosis.
• Pathologies that can provoke the development of thrombosis due to circulatory disorders (SLE, diabetes, SC anemia, Crohn's disease, etc.)
• Liver diseases that are not included in the list of categorical contraindications
• Pathologies that first appeared during pregnancy or aggravated during gestation
• Postpartum period (about one and a half months).

Precautionary measures

OK Jeanine should be prescribed by a gynecologist after a thorough analysis of the patient's condition through a general and gynecological examination, passing tests and clarifying the intricacies of a family history, dysfunctional conditions in the past, the presence of bad habits and other risk factors. In the case of indications for long-term use, the patient should be informed of the need for regular medical examinations (usually once a year). In addition, she should be warned that OCs cannot protect against sexually transmitted infections and HIV infection.

If a woman has any signs of risk that can accelerate or intensify the onset of new diseases or the complication of existing ones, then the question of the possibility of using OK should be decided individually. In the case of an appointment, the patient must be aware of the possible consequences and know what to do if they occur.

The results of numerous studies have confirmed the presence of a relationship between taking OCs and an increase in cases of pathologies of the heart and blood vessels: myocardial infarction, thrombosis, PE, VTE, etc. Although such complications occur quite rarely, a threat cannot be ruled out.

The occurrence of VTE occurs especially often in the first year of taking OCs. An increase in risk is also noted when the course of OK is resumed after a break (at least a month). This usually happens in the first three months of taking contraceptives.

In addition, there are data on isolated cases when the use of OK led to death.

Damage to the vessels of other organs is less common, so the opinions of physicians are divided on the issue of "guilt" OK. Manifestations of HV thrombosis include the development of unilateral swelling of the leg (possible soreness in the region of the vein), pain and discomfort in the limb when walking or standing, local temperature, change in skin tone.

PE can be recognized by the following signs:

• Complicated breathing
• Unexplained cough (comes with blood)
• Severe chest pain, worse on inspiration
• Vertigo
• Violation of the normal heartbeat.

In addition, dyspnea and cough can be harbingers of PE, so it is important to interpret them correctly, not to confuse them with manifestations of other diseases.

Arterial TE can provoke a stroke, myocardial infarction, and vascular damage. Its manifestations are:

• Unexpected Weakness
• Insensitivity of the face, limbs (specific symptom - unilateral paresthesia)
• Spontaneous confusion
• Speech disorder
• A sharp deterioration in vision
• Gait disorder
• Disorientation in space
• Uncoordinated movements, loss of balance
• Spontaneous severe head pain
• Fainting (may be with an epileptic seizure).

Typical signs of MI are:

• Pain and discomfort in the chest, feeling of heaviness or fullness
• Unpleasant sensations radiating to the back, arm, stomach
• Cold perspiration, sweat
• Nausea (with or without vomiting)
• Unexplained weakness, dyspnea
• Increased anxiety
• Rapid heartbeat.

The threat of thrombosis increases:

• As age increases
• Smokers (especially women 35+ with a long history)
• With obesity
• The presence of pathology in relatives
• Prolonged immobility (including during long flights)
• With hypertension, pathology of the heart valves, damage to the atria
• Postnatal period.

Women who have recently given birth, diabetics, patients with systemic lupus erythematosus, chronic intestinal inflammation, and MC anemia are also at risk.

The occurrence of migraines or worsening attacks is a reason to cancel OK.

Cross-drug interactions

Combining OCs with other medications may cause breakthrough bleeding or reduce the effect of OCs, increasing the risk of unintended pregnancy. Therefore, Janine's instructions for use advise taking contraceptive pills, taking into account possible complications. Such undesirable reactions appear with the following combinations:

• The use of drugs-inducers of liver enzymes can increase the clearance of sex hormones. Such reactions are manifested when Jeanine is combined with barbiturates, Phenytoin, anti-tuberculosis Rifampicin. It is assumed that the same actions have Oxcarbazpin, Griseofulvin, medications based on St. John's wort.
• Similar effects can be observed when combined with HIV protease inhibitors (PI) and NNRTIs: Ritonavir and Nevirapine, since drugs directly affect the rate of hepatic metabolism.
• Separate antibiotic drugs (primarily tetracycline and penicillin groups) are able to reduce the content of ethinyl estradiol by reducing the circulation of estrogens in the liver and intestines. Therefore, if treatment with these agents is necessary, the patient is advised to additionally protect herself with other barrier agents or products.
• The action of OK changes under the influence of drugs inhibitors of cytochrome enzymes CYP3A4. The plasma content of Jeanine substances will be increased when the contraceptive drug is combined with Ketoconazole and other antimycotics, Cimetidine, Erythromycin, psychotropic drugs (antidepressants), as well as grapefruit juice.
• If drugs that affect liver enzymes were used during the Janine course, then after their cancellation, auxiliary means of protection against pregnancy should be used within 28 days.
• Antibiotics reduce the contraceptive effect of OK (except for Rifampicin, griseofulvin), therefore, during their course and within a week after cancellation, you should either refrain from intimacy or additionally protect yourself.
• Oral contraceptives can also change the actions of other drugs. Jeanine increases the plasma content of Cyclosporine and reduces Laomtrigine.

If at the time of Zhanine's appointment the conditions for combining with other medications were not agreed, then in the case of other drugs being prescribed, it is necessary to inform the doctor about the OK being taken and clarify the nuances of the joint intake.

Side effects and overdose

During the use of Janine tablets, the following responses of the body are possible:

• Infectious pathologies: vaginitis, thrush, salpinogo-oophoritis, herpes lesions of the oral cavity, flu-like condition, bronchitis, diseases of the urinary tract, respiratory system
• Neoplasms of any etiology, uterine fibromyoma, lipoma (wen) of the mammary gland
• Hematopoietic organs: anemia
• Individual reactions due to hypersensitivity
• virilism
• Metabolic processes: increased or lack of appetite
• Psycho-emotional state: mental disorders, depression, depression, sleep disturbance, insomnia, unmotivated aggression, mood lability, loss of sexual interest
• NS: headache, vertigo, migraine, stroke, circulatory disorders in the brain, dystonia
• Organs of vision: dryness of the mucous tissues of the eyes, irritation, decreased visual acuity, pain, inability to wear contact lenses
• Hearing organs: temporary hearing loss or reduction, tinnitus
• CCC: cardiovascular complications, palpitations, a sharp increase or decrease in blood pressure, thrombosis, thrombophlebitis, varicose veins, flushing of the face, dilation and soreness of the veins
• Respiratory system: asthma attacks, hyperventilation
• Gastrointestinal tract: pain in the peritoneum, nausea, vomiting, diarrhea, gastritis, inflammation of the small intestine, difficult digestion
• Skin: acne, rash, hair loss, alopecia, itching, dermatitis (allergic and atopic), hyperpigmentation, chloasma, seborrhea, male pattern hair, cellulitis, nevus, urticaria, erythema multiforme
• Locomotor system: pain in the spinal muscles, bones, limbs
• Reproductive system: chest discomfort and soreness, intermenstrual bleeding, cyst (uterus, mammary glands), mastopathy, MC disorder, nipple discharge
• Other disorders: fatigue, chest pain, peripheral edema, flu-like condition, irritability, accumulation of fluid in the body, weight change (increase or decrease), increased TG content in the blood.

Possible risks of using Jeanine

• Women who use hormonal OCs are slightly more likely to be diagnosed with breast cancer than women who do not take contraceptives. So far, there is no evidence of a direct dependence of the occurrence of pathology on the intake of OK.
• In patients with congenital angioedema, the risk of exacerbation increases.
• Increased risk of liver damage
• Impaired glucose tolerance, insulin resistance
• Bleeding of a breakthrough, if other drugs were used during the use of Zhanine OK.

Consequences of taking overdose

The active ingredients practically do not have acute toxicity, so the development of intoxication is unlikely. It is assumed that Jeanine's medicine, taken in overdose, can cause an increase in side effects, but mostly the consequences are manifested in the form of nausea, bouts of vomiting, and girls may experience spotting.

Due to the lack of a specific antidote to Jeanine, the unfavorable condition that has arisen is removed with the help of symptomatic therapy.

Analogues

If a woman for some reason cannot take a medication, she needs to contact a gynecologist so that he can determine how to replace Jeanine. To date, there are many drugs that are no less effective: Bonade, Vidora, Jess and Jess Plus, Microgenon, Leia, etc. Which drug is best suited - only an experienced specialist will determine.

Laboratorios Leon-Farma (Spain)

Average cost:(21 pcs.) - 395 rubles, (63 pcs.) - 876 rubles.

An oral contraceptive containing the same composition of active ingredients and in an identical dosage as in Jeanine. A slight difference lies only in the composition of the auxiliary ingredients that make up the structure of the core and shell, and the dosage form: the medication is produced in tablets.

The scheme of reception is also similar: one piece per day.

Pros:

• Helps with serious violations of the reproductive system
• Can be drunk for a long time.

Flaw:

• side effects
• Decreased sensitivity in erogenous zones.

GEDEON RICHTER (Hungary)

Average cost: No. 21 - 723 rubles, No. 63 - 1813 rubles.

A contraceptive medication, the action of which is provided by ethinyl estradiol and chloramadinone in the form of acetate.

OK is available in tablets. The drug is designed for a 21-day intake with the obligatory observance of a week break for withdrawal bleeding.

Pros:

• Good quality
• Protects against unwanted pregnancy.

Disadvantages:

• Pimples appear
• Reduces interest in sex.

Catad_pgroup Combined oral contraceptives

The most physiological contraceptive that preserves the quality of sexual life. For the treatment of heavy and / or prolonged menstrual bleeding without organic pathology.
INFORMATION IS PROVIDED STRICTLY
FOR HEALTHCARE PROFESSIONALS

Jeanine - official * instructions for use

JEANINE ®

Registration number:

P N013757/01

Tradename

Dosage form

Composition

Each dragee contains:

Active ingredients: ethinylestradiol 0.03 mg and dienogest 2.0 mg.

Excipients: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate, sucrose, dextrose (glucose syrup), macrogol 35000, calcium carbonate, povidone K25, titanium dioxide (E 171), carnauba wax.

Description

White smooth dragees.

Pharmacotherapeutic group

Combined contraceptive (estrogen + gestagen)

ATX code G03AA

Pharmacological properties

Pharmacodynamics

Jeanine is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug.

The contraceptive effect of Jeanine is mediated through complementary mechanisms, the most important of which are the suppression of ovulation and the change in the viscosity of the cervical mucus, making it impermeable to spermatozoa.

When used correctly, the Pearl Index (an indicator that reflects the number of pregnancies in 100 women taking a contraceptive during the year) is less than 1. If pills are missed or used incorrectly, the Pearl index may increase.

The gestagenic component of Zhanin - dienogest - has antiandrogenic activity, which is confirmed by the results of a number of clinical studies. In addition, dienogest improves the lipid profile of the blood (increases the amount of high density lipoproteins).

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful periods are less common, the intensity and duration of bleeding decreases, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence of a reduced risk of endometrial cancer and ovarian cancer.

Pharmacokinetics

· Dienogest

Absorption. When taken orally, dienogest is rapidly and completely absorbed, its maximum serum concentration of 51 ng / ml is reached after about 2.5 hours. Bioavailability is approximately 96%.

Distribution. Dienogest binds to serum albumin and does not bind to sex steroid-binding globulin (SHBG) and corticoid-binding globulin (CBG). In the free form is about 10% of the total concentration in the blood serum; about 90% are not specifically associated with serum albumin. Induction of SHBG synthesis by ethinylestradiol does not affect the binding of dienogest to whey protein.

Metabolism. Dienogest is almost completely metabolized. Serum clearance after a single dose is approximately 3.6 l/h.

Withdrawal. The half-life is about 8.5-10.8 hours. A small amount in unchanged form is excreted by the kidneys in the form of metabolites (half-life - 14.4 hours), which are excreted by the kidneys and through the gastrointestinal tract in a ratio of approximately 3:1.

Equilibrium concentration. The pharmacokinetics of dienogest is not affected by the level of SHBG in the blood serum. As a result of daily administration of the drug, the level of the substance in the serum increases by about 1.5 times.

· Ethinylestradiol

Absorption. After oral administration, ethinylestradiol is rapidly and completely absorbed. The maximum concentration in blood serum, equal to approximately 67 pg / ml, is reached in 1.5-4 hours. During absorption and first passage through the liver, ethinylestradiol is metabolized, resulting in its oral bioavailability averaging about 44%.

Distribution. Ethinyl estradiol is almost completely (approximately 98%), although non-specific, bound to albumin. Ethinylestradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinylestradiol is 2.8 - 8.6 l / kg.

Metabolism. Ethinylestradiol undergoes presystemic conjugation both in the small intestine mucosa and in the liver. The main metabolic pathway is aromatic hydroxylation. The rate of clearance from blood plasma is 2.3 - 7 ml / min / kg. Withdrawal. The decrease in the concentration of ethinylestradiol in the blood serum is biphasic; the first phase is characterized by a half-life of about 1 hour, the second - 10-20 hours. It is not excreted from the body unchanged. Metabolites of ethinyl estradiol are excreted in the urine and bile in a ratio of 4: 6 with a half-life of about 24 hours.
equilibrium concentration. The equilibrium concentration is reached during the second half of the treatment cycle.

Indications for use

Contraception.

Contraindications

Jeanine should not be used in the presence of any of the conditions/diseases listed below. If any of these conditions develop for the first time while taking it, the drug should be immediately discontinued.

Thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.
Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history.
· Migraine with focal neurological symptoms at present or in history.
· Diabetes mellitus with vascular complications.
Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, cerebrovascular disease or coronary artery disease; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years.
Pancreatitis with severe hypertriglyceridemia at present or in history.
Liver failure and severe liver disease (before normalization of liver tests).
Liver tumors (benign or malignant) at present or in history.
Identified hormone-dependent malignant diseases (including the genital organs or mammary glands) or suspicion of them.
Bleeding from the vagina of unknown origin.
Pregnancy or suspected pregnancy.
The period of breastfeeding.
· Hypersensitivity to any of the components of the drug Jeanine.

With caution

The potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case in the presence of the following diseases / conditions and risk factors:

· Risk factors for the development of thrombosis and thromboembolism: smoking; obesity; dyslipoproteinemia, arterial hypertension; migraine; valvular heart disease; prolonged immobilization, major surgical interventions, extensive trauma; hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the next of kin)
Other diseases in which peripheral circulation disorders may occur: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; phlebitis of superficial veins
Hereditary angioedema
Hypertriglyceridemia
Liver diseases
Diseases that first arose or worsened during pregnancy or due to previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing loss, porphyria, herpes pregnant, Sydenham's chorea)
Postpartum period

Pregnancy and lactation
Janine should not be used during pregnancy and while breastfeeding. If pregnancy is detected while taking the drug Jeanine, it should be immediately discontinued and consult a doctor. However, extensive epidemiological studies have not found an increased risk of developmental defects in children born to women who received sex hormones before pregnancy or who inadvertently took sex hormones in early pregnancy.
Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding is stopped.

Dosage and administration

When and how to take dragees
The calendar package contains 21 dragees. In the package, each dragee is marked with the day of the week on which it should be taken. Take the tablets by mouth at the same time each day with a small amount of water. Follow the direction of the arrow until all 21 pills have been taken. You do not take the drug for the next 7 days. Menstruation (withdrawal bleeding) must begin within these 7 days. It usually starts 2-3 days after taking the last Janine dragee. After a 7-day break, start taking the pills from the next package, even if the bleeding has not yet stopped. This means that you will always start a new pack on the same day of the week, and that withdrawal bleeding will occur around the same day of the week each month.
Reception of the first package of Jeanine
When no hormonal contraceptive has been used in the previous month
Start taking Janine on the first day of your cycle, which is the first day of your menstrual bleeding. Take the dragee that is labeled with the corresponding day of the week. Then take the pills in order. You can also start taking on days 2-5 of the menstrual cycle, but in this case, you must use an additional barrier method of contraception (condom) during the first 7 days of taking the pills from the first package.
When switching from other combined oral contraceptives, vaginal ring or contraceptive patch
You can start taking Janine the day after you take the last pill of your current pack of combined oral contraceptives (i.e., without interruption). If the current package contains 28 tablets, you can start taking Janine the day after taking the last active tablet. If you are not sure which tablet it is, ask your doctor. You can also start taking later, but in no case later than the next day after the usual break in taking (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per pack).
Janine should be started on the day the vaginal ring or patch is removed, but no later than the day a new ring or patch is to be inserted.
When switching from oral contraceptives containing only progestogen (mini-pill)
You can stop taking the mini-pill any day and start taking Janine the next day, at the same time. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.
When switching from an injectable contraceptive, an implant, or a progestogen-releasing intrauterine contraceptive (Mirena)
Start Janine on the day your next injection is due or on the day your implant or intrauterine contraceptive is removed. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.
· After childbirth
If you have just had a baby, your doctor may recommend that you wait until your first normal menstrual period has ended before you start taking Jeanine. Sometimes, on the recommendation of a doctor, it is possible to start taking the drug earlier.
After a spontaneous miscarriage or abortion in the first trimester of pregnancy
Check with your doctor. It is usually recommended to start taking immediately.
Taking missed pills
· If the delay in taking the next pill is less than 12 hours, the contraceptive effect of Zhanin is preserved. Take the dragee as soon as you remember it. Take the next pill at the usual time.
· If the delay in taking the pill was more than 12 hours, contraceptive protection may be reduced. The more pills missed in a row, and the closer this pass is to the beginning of the intake or to the end of the intake, the higher the risk of pregnancy.
In this case, you can follow the following rules:
· Forgotten more than one tablet from the packageConsult your doctor.
One tablet was missed in the first week of taking the drug
Take the missed pill as soon as you remember (even if it means taking two pills at the same time). Take the next pill at the usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse took place within a week before skipping the dragee, the likelihood of pregnancy should be considered. Consult your physician immediately.
One tablet was missed in the second week of taking the drug
Take the missed pill as soon as you remember (even if it means taking two pills at the same time). Take the next pill at the usual time. If you have taken the pills correctly in the 7 days preceding the first missed pill, the contraceptive effect of Jeanine is maintained and you do not need to use additional contraceptive measures. Otherwise, as well as skipping two or more pills, you must additionally use barrier methods of contraception for 7 days.
One tablet was missed in the third week of taking the drug
If during the 7 days preceding the first missed pill, all the pills were taken correctly, there is no need to use additional contraceptive methods. You can stick to either of the following two options
1. Take the missed pill as soon as you remember (even if it means taking two pills at the same time). Take the next pill at the usual time. Start the next pack immediately after finishing taking the pills from the current pack, so there will be no break between packs. Withdrawal bleeding is unlikely until the pills in the second pack are finished, but there may be spotting or breakthrough bleeding on the days of taking the drug.
2. Stop taking the pills from the current package, take a break of 7 days or less (including the day you missed the pills) and then start taking the pills from the new package.

Using this scheme, you can always start taking the pills from the next pack on the day of the week when you usually do it.
If you don't have your expected period after you stop taking the pills, you may be pregnant. Consult your doctor before you start taking pills from a new package.
In situations where you are advised to stop taking a combined oral contraceptive, or where the reliability of COCs may be reduced, you should abstain from sexual intercourse or use non-hormonal contraceptive methods (for example, a condom or other barrier methods). Do not use rhythmic or temperature methods. These methods can be unreliable because taking COCs leads to changes in temperature and cervical mucus.
Recommendations in case of vomiting and diarrhea
If you have had vomiting or diarrhea (indigestion) up to 4 hours after taking Jeanine tablets, the active substances may not have been completely absorbed. This situation is similar to skipping a drug. Therefore, follow the instructions for missed pills.
Delaying the onset of menstruation
You can delay the onset of your period if you start taking the next pack of Jeanine immediately after the end of the current pack. You can continue taking the pills in this package for as long as you wish, or until the package runs out. If you want your period to start, stop taking the dragee. While taking Janine from the second package, spotting or bleeding may occur on the days of taking the dragee. Start the next pack after the usual 7-day break.
Changing the day of your period
If you take the pills as recommended, you will have your period on about the same day every 4 weeks. If you want to change it, shorten (but do not lengthen) the period of time free from taking pills. For example, if your menstrual cycle usually starts on Friday and in the future you want it to start on Tuesday (3 days earlier), the next pack should start 3 days earlier than usual. If the pill-free break is very short (for example, 3 days or less), menstruation may not occur during the break. In this case, bleeding or spotting may occur while taking the pills from the next package.

Additional information for special categories of patients
Children and teenagers
The drug Jeanine is indicated only after the onset of menarche.
Elderly patients
Not applicable. Jeanine is not indicated after menopause.
Patients with liver disorders
Jeanine is contraindicated in women with severe liver disease until liver function tests return to normal. See also section "Contraindications".
Patients with kidney disorders
Jeanine has not been specifically studied in patients with renal impairment. Available data do not suggest a change in treatment in these patients.

Side effect

When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.
While taking the drug Jeanine, other undesirable effects may be observed, although their appearance is not necessary in all patients.
Serious unwanted effects:
See sections "With caution" and "Special instructions". Please read these sections carefully and if you experience any adverse effects, including serious reactions associated with the use of the drug, consult your doctor.
Other undesirable effects identified during the study of the drug Janine:
Common side effects (more than 1/100 and less than 1/10):
- headache;
- pain in the mammary glands, including discomfort in the mammary glands and engorgement of the mammary glands.
Uncommon side effects (more than 1/1000 and less than 1/100):
- vaginitis / vulvovaginitis (inflammation of the female genital organs);
- vaginal candidiasis (thrush) or other fungal vulvovaginal infections;
- increase in appetite;
- decrease in mood;
- dizziness;
- migraine;
- high or low blood pressure;
- abdominal pain (including pain in the upper and lower abdomen, discomfort / bloating);
- nausea, vomiting or diarrhea;
- acne;
- alopecia (hair loss);
- rash (including patchy rash);
- itching (sometimes itching of the whole body);
- abnormal menstruation, including menorrhagia (heavy menstruation), hypomenorrhea (scanty menstruation), oligomenorrhea (irregular menstruation), and amenorrhea (absence of menstruation);
- intermenstrual bleeding, including vaginal bleeding and metrorrhagia (irregular bleeding between periods);
- an increase in the size of the mammary glands, including swelling and bursting of the mammary glands;
- swelling of the mammary glands;
- dysmenorrhea (painful menstruation);
- vaginal discharge;
- ovarian cysts;
- pain in the pelvic area;
- fatigue, including asthenia (weakness) and malaise (fatigue, including weakness and general malaise);
- weight change (increase or decrease).
Rare side effects (more than 1/10000 and less than 1/1000):
- adnexitis (inflammation of the fallopian (uterine) tubes and ovaries);
- urinary tract infections;
- cystitis (inflammation of the bladder);
- mastitis (inflammation of the mammary gland);
- cervicitis (inflammation of the cervix);
- candidiasis or other fungal infections;
- herpetic lesions of the oral cavity;
- flu;
- bronchitis;
- sinusitis;
- infections of the upper respiratory tract;
- viral infection;
- uterine fibroids (benign neoplasms in the uterus);
- breast lipoma (benign neoplasms of adipose tissue);
- anemia;
- hypersensitivity (allergic reactions);
- virilism (development of male secondary sexual characteristics);
- anorexia (severe loss of appetite);
- depression;
- mental disorders;
- insomnia;
- sleep disorders;
- aggression;
- ischemic stroke (reduced or suddenly stopped blood supply to part of the brain);
- cerebrovascular disorders (disorders of the blood flow system to the brain);
- dystonia (muscle tension (contractures) caused by an uncomfortable posture);
- dryness or irritation of the mucous membrane of the eyes;
- oscillopsia (impaired visual clarity, the illusion of motionless objects fluctuating) or other visual disturbances;
- sudden hearing loss;
- noise in ears;
- dizziness;
- hearing impairment;
- cardiovascular disorders (impaired blood supply to the heart);
- tachycardia (rapid heartbeat);
- thrombosis (formation of a blood clot in the blood vessels);
- pulmonary embolism (acute blockage of the branches of the pulmonary artery by blood clots);
- thrombophlebitis (inflammation of the venous wall with the formation of a blood clot in the lumen of the vein);
- an increase in diastolic pressure (the minimum indicator of blood pressure, corresponds to the pressure in the arterial vessels between heartbeats);
- orthostatic circular dystonia (feeling of dizziness, weakness or fainting when changing body position from sitting or lying to vertical);
- tides;
- phlebeurysm;
- pathology of veins, pain in the area of ​​veins;
- bronchial asthma;
- hyperventilation;
- gastritis;
- enteritis;
- dyspepsia (indigestion);
- skin reactions;
- skin pathology, including allergic dermatitis, neurodermatitis / atopic dermatitis, eczema, psoriasis;
- hyperhidrosis (excessive sweating);
- Chloasma (golden brown spots, the so-called "spots of pregnant women", mainly on the face);
- violation of pigmentation / hyperpigmentation;
- seborrhea (oily skin);
- dandruff;
- hirsutism (male pattern hair growth);
- Orange peel;
- spider veins (expansion of subcutaneous vessels in the form of a mesh with a central red spot);
- back pain;
- discomfort in the muscles and bones of the skeleton;
- myalgia (muscle pain);
- pain in the arms and legs;
- cervical dysplasia (abnormal changes in the epithelium of the cervix);
- pain in the area of ​​the uterine appendages or cysts of the uterine appendages (ovaries and fallopian (uterine) tubes);
- breast cysts;
- fibrocystic mastopathy (benign neoplasms in the mammary glands);
- dyspareunia (pain during intercourse);
- galactorrhea (milk secretion);
- violations of the menstrual cycle;
- chest pain;
- peripheral edema;
- flu-like conditions;
- inflammation.
Undesirable effects identified during the study of the drug, the frequency of which is unknown: mood changes, increased or decreased libido, contact lens intolerance, urticaria, skin disorders (such as erythema nodosum or multiforme), discharge from the mammary glands, fluid retention.
If you have hereditary angioedema, medicines that contain certain female sex hormones (estrogens) may cause symptoms to worsen (see Precautions section).
If any of the side effects gets serious or if you notice any side effects not listed in the instructions, please tell your doctor or pharmacist.
Overdose
Serious violations with a single dose of a large number of Zhanin dragees were not reported.
Symptoms that may occur in overdose include nausea, vomiting, spotting or vaginal bleeding.
In case of overdose, you should consult a doctor.

Interaction with other drugs

Some medicines may reduce the effectiveness of Jeanine. These include drugs used to treat epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (eg, rifampicin, rifabutin), and HIV infection (eg, ritonavir, nevirapine); antibiotics for certain other infectious diseases (eg, penicillin, tetracyclines, griseofulvin); and St. John's wort (used mainly in the treatment of low mood).
Oral combined contraceptives may interfere with the metabolism of other drugs (eg, cyclosporine and lamotrigine).
Some medicines may interfere with the metabolism of the active ingredients in Jeanine. These include antifungal drugs (eg, ketoconazole), H2 blockers to treat gastric and duodenal ulcers (eg, cimetidine), some drugs to treat hypertension (eg, verapamil, diltiazem), antibiotics to treat bacterial infections (macrolides, erythromycin), antidepressants, grapefruit juice.
Always tell your doctor who prescribes Janine what medicines you are already taking. Also tell any doctor or dentist who prescribes other drugs, or any pharmacist who sells you drugs at a pharmacy, that you are taking Janine.
In some cases, your doctor may recommend that you additionally use a barrier method of contraception (condom).

special instructions

The following warnings regarding the use of other combined oral contraceptives should also be taken into account when using Janine.
Thrombosis
Thrombosis is the formation of a blood clot (thrombus) that can block a blood vessel. When a thrombus breaks off, thromboembolism develops. Sometimes thrombosis develops in the deep veins of the legs (deep vein thrombosis), the vessels of the heart (myocardial infarction), the brain (stroke), and very rarely in the vessels of other organs.
The risk of deep vein thrombosis in women taking combined oral contraceptives is higher than in those who do not use them, but not as high as during pregnancy.
The risk of thrombosis increases with age and also increases with the number of cigarettes smoked. When using Jeanine, you should stop smoking, especially if you are over 35 years old.
The risk of deep vein thrombosis is temporarily increased during surgery or prolonged immobilization (immobility), for example, when applying a cast to the leg, prolonged bed rest. In the event of a planned operation or hospitalization, tell your doctor in advance that you are taking combined oral contraceptives. Your doctor may recommend that you stop using the drug (if you are going to have surgery, at least four weeks before it) and not resume taking it until two weeks after the end of immobilization.
If high blood pressure is detected, your doctor may recommend that you stop taking combined oral contraceptives.
Tumors
The relationship between taking combined oral contraceptives and breast cancer has not been proven, although in women taking combined oral contraceptives, it is detected slightly more often than in women of the same age who do not use them. Perhaps this difference is due to the fact that when taking the drug, women are examined more often and therefore breast cancer is detected at an early stage.
In rare cases, against the background of the use of sex steroids, the development of benign, and in extremely rare cases, malignant liver tumors, which can lead to life-threatening intra-abdominal bleeding, was observed. The relationship with the use of drugs has not been proven. If you suddenly develop severe abdominal pain, consult your doctor immediately.
The most significant risk factor for developing cervical cancer is persistent papillomavirus infection. Cervical cancer was detected slightly more often in women using combined oral contraceptives for a long period of time. The relationship with the use of combined oral contraceptives has not been proven. This may be due to more frequent gynecological examinations to detect diseases of the cervix or to the characteristics of sexual behavior (more rare use of barrier methods of contraception).
Reduced efficiency
The effectiveness of combined oral contraceptive preparations may be reduced in the following cases: when you skip pills, when vomiting and diarrhea, or as a result of drug interactions.
Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
In women with hereditary forms of angioedema exogenous estrogens may cause or worsen symptoms of angioedema

Intermenstrual bleeding
As with other combined oral contraceptives, irregular vaginal bleeding (spotting or breakthrough bleeding) between menstrual periods may occur during the first few months while taking Janine. Use hygiene products and continue taking the tablets as usual. Intermenstrual vaginal bleeding usually stops as your body adapts to Jeanine (usually after 3 cycles of pills). If they continue, become severe, or recur after stopping, see your doctor.
Absence of another menstruation
If you took all the pills correctly, and you did not vomit while taking the pills or taking other medications at the same time, then the chance of pregnancy is low. Continue taking Janine as usual.
If you miss two periods in a row, see your doctor immediately. Do not start taking the pills from the next package until the doctor has ruled out pregnancy.

When to consult a doctor
Regular checkups
If you are taking Jeanine, your doctor will tell you to have regular checkups, at least once a year.
Consult your doctor as soon as possible:

• for any health condition, especially any of the conditions listed in this package insert (see also "Contraindications" and "Use with caution");
• with local compaction in the mammary gland; if you are going to use other medicines (see also "Interaction with other medicines");
• if prolonged immobility is expected (for example, a cast is applied to the leg), hospitalization or surgery is planned (consult your doctor at least 4 to 6 weeks before);
• if you experience unusual heavy vaginal bleeding;
• if you forgot to take a pill in the first week of taking the package and had sexual intercourse seven days before;
• you have missed your next period twice in a row or suspect you are pregnant (do not start the next pack until you have consulted with your doctor).

Stop taking the dragee and consult your doctor immediately if you notice possible signs of thrombosis: first-time: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath; unusual, severe or prolonged headache or migraine attack; partial or complete loss of vision or double vision; inarticulate speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe pain in the abdomen; severe pain in the leg or sudden swelling of any of the legs.

Photo of the drug

Latin name: Jeanine

ATX Code: G03AA14

Active substance: Ethinylestradiol (Ethinylestradiol) + Dienogest (Dienogest)

Manufacturer: Bayer Pharma (Germany)

Products webpage: bayer.ru

The description applies to: 09.11.17

Jeanine is a hormonal contraceptive drug.

Active substance

Ethinylestradiol (Ethinylestradiol) + Dienogest (Dienogest).

Release form and composition

Released in the form of white smooth dragees, each 21 of which are packed in blisters. One or three blisters are enclosed in a cardboard pack.

Indications for use

Prevention of unwanted pregnancy.

It is used as the main and auxiliary treatment for the following conditions and diseases:

• dysmenorrhea (painful menstruation);
• amenorrhea (lack of menstruation);
• menorrhagia (heavy menstruation);
• endometriosis;
• violation of reproductive function;
• an increased content of male sex hormones in the blood of a woman (which often results in acne, very oily skin, excessive hair growth of the skin);
• the period after gynecological surgical interventions (in order to recover after the operation and consolidate its results).

Contraindications

• period of pregnancy and lactation;
• venous and arterial thrombosis, thromboembolism and conditions preceding them (angina pectoris, ischemia);
• neurological migraines;
• cardiovascular complications of diabetes;
• lesions of the valvular apparatus of the heart, arrhythmias, vascular diseases of the brain and heart;
• liver failure, liver disease, incl. tumors;
• malignant formations of the genital organs and mammary glands;
• after major surgery.

Instructions for use Jeanine (method and dosage)

Dragees are taken orally 1 piece per day at the same time, adhering to the order indicated on the drug package. The duration of the course is 21 days, then a break is made for 7 days. Menstruation begins 2-3 days after the end of the drug.

Switching from other drugs

If hormonal preparations have not been previously taken, the course begins on the first day of menstruation. It is acceptable to start on days 2-5 of MC, however, in this case, it is recommended to use additional barrier methods of contraception for 7 days.

When switching from other oral contraceptives, the intake should be started the next day after taking the last pill from the previous package. A break of more than 7 days should not be allowed.

When switching to drugs after removing the vaginal ring, you should start taking the pills on the day the ring or patch is removed.

When changing progestin contraceptives to drugs, you can start taking the drug at any time - on the day the implant is removed or the last injection. In this case, within 7 days it is necessary to use additional methods of contraception.

After the abortion

After an abortive termination of pregnancy in the first trimester, you can start taking it on the day of the operation. Additional contraception is not required.

After an abortion in the 2nd trimester or childbirth, the drug should be started on the 21-28th day after the operation or childbirth. In the case of a later start of the course, it is recommended to use additional (barrier) contraceptives.

In the event of a missed appointment

If you skip taking the drug for less than 12 hours, the effect of the contraceptive is not reduced. A woman should take the pills as soon as she remembers, and the next ones are taken as usual.

If the interval between tablets is more than 36 hours, the following recommendations should be followed:

• If you miss a tablet in the first week, it is recommended to immediately take the dragee and continue the course as usual. Within 7 days, it is recommended to additionally use barrier methods of contraception.
• If a tablet is missed at week 2, it is necessary to take the tablet as soon as possible and continue therapy at the recommended dosage. If there has not been a missed dose of the drug before, additional methods of contraception are not required.
• If a dose is missed in the third week, the woman should take the pill as soon as possible and continue taking the current pack. In this case, a break before starting the next package is not required. During this period, menstrual bleeding is extremely rare, but menstruation will begin after the end of the second package. Otherwise, a woman can take a seven-day break (taking into account the missed day) and then start taking the drug from a new package.

If vomiting or diarrhea occurs within four hours after taking the drug, the absorption of the active ingredient may not be complete, so additional contraception is required. In this case, it is required to adhere to the rules regarding skipping the intake of dragees.

If it is necessary to delay the onset of menstruation, it is necessary to start taking pills from a new package immediately after the end of the previous one (without interruption). To shorten the duration of MC, it is necessary to stop taking the drug as soon as the woman needs.

Side effects

Jeanine may cause the following side effects:

• headache;
• soreness and engorgement of the mammary glands;
• increased appetite;
• dizziness;
• bleeding in the intermenstrual period;
• nausea;
• violation of the psycho-emotional state.

Significantly less common:

• decreased libido;
• acne
• abdominal pain, diarrhea, vomiting;
• rash, skin itching;
• vaginitis, vulvovaginitis, vaginal candidiasis and other fungal infections;
• hyper- and hypotension.

Very rare side effects include:

• spider veins, cellulite, pigmentation disorder;
• dandruff, seborrhea;
• psoriasis, allergic skin reactions, eczema;
• gastritis;
• varicose veins, thrombophlebitis;
• blurred vision, dryness of the mucous membrane of the eyes;
• sleep disturbance, depression, aggression;
• anemia;
• benign tumors of the uterus and breast.

Overdose

With an overdose of Janine, nausea, metrorrhagia, and vomiting are observed.

Symptomatic therapy is carried out. There is no specific antidote.

Analogues

Analogues for the ATX code: Angeletta, Belara, Bonade, Diecyclen, Genette.

Do not make the decision to change the drug yourself, consult your doctor.

pharmachologic effect

Ethinylestradiol is a synthetic estrogen, when ingested it performs all the functions of endogenous (own) estrogen.

Dienogest can be called an analogue of natural progesterone. Despite a slight similarity (only 10%) with progesterone, it has a powerful progestogenic activity (it can effectively mimic the action of progesterone).

The pharmacological action of the tablets is contraceptive. It comes as a result of the implementation of three complementary mechanisms:

• Suppression of ovulation by influencing the hypothalamic-pituitary system.
• Changing the properties (mainly viscosity) of cervical mucus in such a way as to make it impermeable to spermatozoa.
• Structural and functional changes in the endometrium, in which implantation of even a fertilized egg cannot occur.

The action of the drug is not limited to the contraceptive effect. Against the background of admission, the menstrual cycle normalizes, pain and the amount of discharge during menstruation decrease, the development of certain gynecological diseases is prevented or suspended, and the reproductive function of a woman is restored. After regular use of the drug, there is an improvement in the condition of the skin, hair, nails, the drug has a positive effect on the female body as a whole.

special instructions

Taking pills does not protect against sexually transmitted diseases.

Before the appointment, a complete medical examination of the patient is carried out and the possibility of pregnancy is excluded.

During pregnancy and breastfeeding

Contraindicated during pregnancy and breastfeeding.

In childhood

It is not prescribed for children and adolescents under 18 years of age.

In old age

It is used in the elderly after the onset of menopause.

For impaired renal function

No information available.

For impaired liver function

Contraindicated in severe liver disease.

drug interaction

• Complex administration with phenytoin, barbiturs, rifampicin, primidone, carbamazepine, topiramate, felbamate can lead to an increase in the clearance of sex hormones. In this case, it is additionally recommended to use barrier methods of contraception.
• Non-nucleoside reverse transcriptase and HIV protease inhibitors may impair hepatic metabolism.
• Antibiotics of the penicillin and tetracycline series reduce the enterohepatic circulation of estrogens, which can lead to a decrease in the level of ethinyl estradiol.

Terms of dispensing from pharmacies

Released by prescription.

Terms and conditions of storage

4.29 out of 5 (12 Votes)

Prices in online pharmacies:

Dosage form

Sugar-coated tablets

Composition

One tablet contains

active substances: ethinylestradiol 0.03 mg,

dienogest 2.0 mg,

excipients: lactose monohydrate, corn starch, maltodextrin, magnesium stearate,

shell composition: sucrose, liquid glucose, calcium carbonate, povidone K 25, macrogol 35000, titanium dioxide (E 171), carnauba wax.

Description

Smooth, white, sugar-coated tablets, round shape

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system.

Hormonal contraceptives for systemic use.

Progestogens and estrogens (fixed combination). dienogest and estrogen.

ATX code G03AA16

Pharmacological properties

Pharmacokinetics

Dienogest

Absorption

After oral administration, dienogest is rapidly and almost completely absorbed, its maximum serum concentration of 51 ng / ml is reached after about 2.5 hours. Bioavailability in combination with ethinyl estradiol is approximately 96%.

Distribution

Dienogest binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) and corticoid-binding globulin (CBG). In the free form is about 10% of the total concentration in the blood serum; about 90% - non-specifically associated with serum albumin. The induction of SHBG synthesis by ethinylestradiol does not affect the binding of dienogest to whey protein. The apparent volume of distribution for dienogest is approximately 37-45 L/kg.

Metabolism

Dienogest is metabolized predominantly by hydroxylation and conjugation to form inactive metabolites. These metabolites are rapidly excreted from the blood plasma, thus, no active metabolite is noted in the plasma, and only dienogest is found in an unchanged state. The total clearance is about 3.6 l / h after a single application.

breeding

A decrease in the level of dienogest in the blood serum occurs with a half-life of about 9 hours. Only a small part of dienogest is excreted by the kidneys in an unchanged state. When administered at a dose of 0.1 mg per kg of body weight, metabolites are excreted in the urine and bile in a ratio of about 3:2. After oral administration, approximately 86% of the received dose is excreted within 6 days, with the main part, 42%, excreted in the first 24 hours, mainly with urine.

Equilibrium concentration

The pharmacokinetics of dienogest does not depend on the level of SHBG. As a result of daily administration of the drug, the level of dienogest in serum increases by about 1.5 times, and the equilibrium concentration is reached after 4 days of administration.

Ethinylestradiol

Absorption

After oral administration, ethinylestradiol is rapidly and completely absorbed. The maximum concentration in blood serum, equal to approximately 67 pg / ml, is reached in 1.5-4 hours. During absorption and first passage through the liver, ethinyl estradiol is metabolized, resulting in an average oral bioavailability of about 44%.

Distribution

Ethinylestradiol is almost completely (approximately 98%), although non-specific, bound to albumin. Ethinylestradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinylestradiol is 2.8 - 8.6 l / kg.

Ethinylestradiol undergoes presystemic conjugation both in the small intestine mucosa and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation, producing various hydroxylated and methylated metabolites, both as free metabolites and as conjugates with glucuronic and sulfuric acids. The rate of clearance from blood plasma is 2.3 - 7 ml / min / kg.

breeding

The decrease in the concentration of ethinylestradiol in the blood serum is biphasic; the first phase is characterized by a half-life of about 1 hour, the second - 10-20 hours. It is not excreted from the body unchanged. Metabolites of ethinylestradiol are excreted in the urine and bile in a ratio of 4:6 with an elimination half-life of about 24 hours.

Equilibrium concentration

The state of equilibrium concentration is reached during the second half of the treatment cycle, when the serum level of the drug increases by about 2 times compared with the level when taking a single dose of the drug.

Pharmacodynamics

All hormonal contraceptives have a very low "method failure" rate when used according to the instructions for use (for example, when pills are missed).

In clinical studies, the following Pearl Index was calculated.

The Pearl Index (adjusted) for estimating "method failure" is 0.182 (upper two-tailed 95% confidence interval: 0.358).

Overall Pearl Index (unadjusted, method failures + patient bias): 0.454 (upper two-tailed 95% CI: 0.701).

Jeanine is an oral combined contraceptive preparation containing ethinyl estradiol and the progestogen dienogest.

The contraceptive effect of Jeanine® is based on the interaction of various factors, the most important of which are the inhibition of ovulation and changes in the secretion of cervical mucus.

Dienogest is a nortestosterone derivative with an in vitro affinity for progesterone receptors 10-30 times less than other synthetic progestogens.

In vivo animal data have demonstrated potent progestogenic and antiandrogenic activity.

Dienogest does not have significant androgenic, mineralocorticoid or glucocorticoid activity in vivo.

It has been established that dienogest contributes to the inhibition of ovulation at a dose of 1 mg per day.

When using high-dose oral contraceptives (0.05 mg ethinyl estradiol), the risk of developing endometrial and ovarian cancer is reduced. The extent to which these data relate to low-dose contraceptives requires further study.

Indications for use

Oral contraception (see section "Special Instructions")

Dosage and administration

The tablets should be taken orally in the order indicated on the package, every day at about the same time, with a little water. Take one tablet per day continuously for 21 days. The next pack is started after a 7-day tablet break, during which withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after taking the last pill and may not end before starting a new pack.

How to start taking Janine®

In the absence of taking any hormonal contraceptives in the previous month

Janine® is started on the first day of the menstrual cycle (i.e. the first day of menstrual bleeding).

When switching from other combined oral contraceptives (COCs)

It is preferable to start taking Janine the next day after taking the last hormone-containing tablet from the previous package of the combined oral contraceptive, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last hormone-free tablet for preparations containing 28 tablets per package).

When switching from the vaginal ring, transdermal patch

It is preferable to start taking Janine® on the day of removal of the last ring or patch, but in no case later than the day when the next ring or patch should have been applied.

When switching from contraceptives containing only gestagens (mini-pill, injectable forms, implant) or from a progestogen-releasing intrauterine system (IUD).

A woman can switch from a mini-pill to Jeanine® on any day (without a break), from an implant or intrauterine contraceptive with a progestogen - on the day it is removed, from an injection form - from the day the next injection was to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.

After an abortion in the first trimester of pregnancy

A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection.

After childbirth or abortion in the second trimester of pregnancy

It is recommended to start taking the drug on the 21-28th day after childbirth or abortion. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if a woman has already lived a sexual life, pregnancy should be excluded before taking Janine®, or it is necessary to wait for the first menstruation.

For information regarding the period of breastfeeding, see the section "Special Instructions"

Taking missed pills

If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. The woman should take the missed tablet as soon as possible, as soon as she remembers, the next tablet is taken at the usual time.

If the delay in taking the tablets was more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:

· The drug should never be interrupted for more than 7 days.

· 7 days of continuous tablet intake are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following advice can be given in daily practice if the delay in taking the tablets was more than 12 hours (the interval from the moment of taking the last tablet is more than 36 hours).

The first week of taking the drug

The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place during the week before missing the tablet, the reliability of the drug is reduced, so the likelihood of pregnancy must be taken into account.

As the number of missed pills increases and the regular break period approaches, the chance of pregnancy increases.

The second week of taking the drug

The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next tablet is taken at the usual time.

If the woman has taken the pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

The third week of taking the drug

The risk of reduced reliability is inevitable due to the upcoming break in taking pills. However, the weakening of contraceptive protection can still be prevented by adjusting the pill schedule. Therefore, by adhering to one of the two schemes proposed below, additional protection measures can be dispensed with, provided that within 7 days before the first tablet was missed, the woman took all the tablets correctly. Otherwise, she should be advised to use the first of the following regimens and, in parallel, use additional methods of contraception for 7 days.

1. The woman should take the last missed pill as soon as she remembers (even if it means taking two pills at the same time). She then continues to take her tablets at the usual time. The next pack should be started immediately after the completion of taking the tablets from the current pack, that is, without interruption in taking the pills. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the tablets.

2. The woman may also stop taking the pills from the current package. Then she should take a break for 7 days, including the day she missed the pill, and then start taking a new pack.

If a woman misses a pill and then does not have withdrawal bleeding during the pill break, pregnancy should be ruled out.

In severe gastrointestinal disorders, the absorption of the drug may be incomplete. In this case, additional contraceptive measures should be taken.

If a woman vomits within 3-4 hours after taking the pill, it is necessary to focus on the advice regarding skipping pills. If a woman does not want to change the normal regimen of taking the drug, she should take an additional tablet if necessary (or 2 tablets from another package).

Changing the start date of the menstrual cycle

In order to delay the onset of menstruation, a woman should continue taking the tablets from the new Jeanine® package immediately after all the tablets from the previous one have been taken, without interruption in taking. Tablets from a new package can be taken for as long as the woman wishes (until the package runs out).

While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Janine® from a new pack after the usual 7-day break.

In order to move the day of the start of menstruation to another day of the week, a woman is advised to shorten the duration of the next break in taking pills by as many days as she wishes. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and subsequently spotting and breakthrough bleeding during the second pack (same as if she would like to delay the onset of her period).

Additional information for special categories of patients

Children and teenagers

Elderly patients

Not applicable. Jeanine® is not indicated after menopause.

Patients with liver disorders

Jeanine® is contraindicated in women with severe liver disease (See also section "Contraindications").

Patients with kidney disorders

Jeanine has not been specifically studied in women with impaired renal function. Available data do not suggest dose adjustment in this group of patients.

Side effects

The following is the frequency of side effects while taking Janine®, based on data from clinical studies:

Often (≥1/100,<1/10)

Headache

Breast pain, including discomfort and tightness

mammary glands

Uncommon (≥1/1000,<1/100)

Vaginitis/vulvovaginitis, vaginal candidiasis, or other fungal vulvovaginal infections

increased appetite

Decreased mood

Dizziness, migraine

Arterial hypertension and hypotension

Pain in the abdomen, including in the upper and lower sections, discomfort and a feeling of "bursting" in the abdomen, nausea, vomiting, diarrhea

Rash, including patchy and acne, alopecia, itching, including generalized

Vaginitis/vulvovaginitis, vaginal candidiasis or others

Pathological withdrawal bleeding, including menorrhagia, hypomenorrhea, oligomenorrhea, amenorrhea, intermenstrual bleeding (vaginal or uterine), enlargement of the mammary glands, including swelling and flushing, swelling of the mammary glands, dysmenorrhea, discharge from the genital tract; ovarian cysts, pelvic pain

Fatigue, including malaise and asthenia

Weight gain

Rarely (≥1/10,000,<1/ 1000)

Hypersensitivity reactions

Salpingo-oophoritis, urinary tract infections, cystitis, mastitis, cervicitis, fungal infections, candidiasis, influenza, oral herpes, bronchitis, sinusitis, upper respiratory tract infections, viral infection

Uterine leiomyoma, breast lipoma

virilization

Anorexia

Depression, mental disorders, insomnia, sleep disorders, aggression

Ischemic stroke, cerebrovascular disorders, dystonia

Dry eye, eye irritation, blurred vision, oscillopsia

Sudden hearing loss, tinnitus, vertigo, hearing loss

Cardiovascular disorders, tachycardia

Venous thromboembolism (VTE), arterial thromboembolism, pulmonary embolism, thrombophlebitis, diastolic

hypertension, orthostatic circulatory dysregulation, hot flashes, varicose veins, vein changes, vein pain

Bronchial asthma, hyperventilation

Dyspepsia, gastritis, enteritis

Allergic dermatitis, atopic dermatitis/neurodermatitis, eczema, psoriasis, hyperhidrosis, chloasma, pigmentation disorders/hyperpigmentation, seborrhoea, dandruff, hirsutism, skin reactions and skin changes, orange skin symptom, spider nevus

Back pain, musculoskeletal discomfort, myalgia, pain in extremities

Cervical dysplasia, adnexal cyst, adnexal pain, breast cyst, fibrocystic breast disease, genital pain associated with intercourse, galactorrhea, menstrual irregularities

Chest pain, peripheral oedema, influenza-like illness, inflammatory disease, pyrexia, irritability

Elevated plasma triglycerides, hypercholesterolemia, weight loss, changes in body weight

Manifestation of an asymptomatic accessory breast

With an unknown frequency (revealed only in the process of post-marketing observations)

Mood changes, decreased libido, increased libido

contact lens intolerance

Urticaria, erythema nodosum, erythema multiforme

Discharge from the mammary glands

Fluid retention

Description of individual adverse reactions

The following adverse reactions have been observed in women using combined oral contraceptives, which are also described in the "Special Instructions" section:

The frequency of breast cancer diagnosis is slightly increased among women taking oral contraceptives. Since breast cancer is rare in women under 40 years of age, the increase in the number of diagnoses is small in relation to the overall risk of developing this disease. Its relationship with the use of combined oral contraceptives has not been proven.

Liver tumors (benign and malignant)

Cervical cancer

Other states

Women with hypertriglyceridemia have an increased risk of developing pancreatitis while taking combined oral contraceptives.

Arterial hypertension

The appearance or worsening of the following conditions, the relationship of which with the use of combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnancy, hearing loss associated with otosclerosis

In women with hereditary angioedema, provoking or exacerbating symptoms of the disease under the influence of exogenous estrogens

Liver dysfunction

Impaired glucose tolerance or effects of peripheral insulin resistance

Crohn's disease and ulcerative colitis

Chloasma

Interactions

Breakthrough bleeding and / or a decrease in the contraceptive effectiveness of the drug due to interactions of combined oral contraceptives with drugs (liver enzyme inducers)

Contraindications

Combined hormonal contraceptives should not be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking a combined hormonal contraceptive, the drug should be immediately discontinued.

Presence or risk of venous thromboembolism

current (on anticoagulant therapy) or history of venous thromboembolism (eg, deep vein thrombosis, or pulmonary embolism)

hereditary or acquired predisposition to venous thromboembolism (for example, resistance to activated protein C (including factor V Leiden), deficiency of antithrombin III, protein C, or protein S

major surgical interventions with prolonged immobilization

high risk of venous thromboembolism due to the presence of multiple risk factors (See also the section "Special Instructions").

Presence or risk of arterial thromboembolism

current or previous arterial thromboembolism (eg, myocardial infarction) or conditions prior to arterial thromboembolism (eg, angina pectoris)

cerebrovascular disease - current or history of stroke, or conditions prior to cerebrovascular disease (eg, transient ischemic attacks)

hereditary or acquired predisposition to arterial thromboembolism (for example, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant)

migraine with a history of focal neurological symptoms

high risk of developing arterial thromboembolism due to the presence of multiple risk factors, such as:

Diabetes mellitus with vascular complications

Severe arterial hypertension

Severe dyslipoproteinemia

Pancreatitis with severe hypertriglyceridemia at present or in history.

Current or history of severe liver disease (before normalization of liver tests)

Liver tumors (benign or malignant) at present or in history

Identified or suspected hormone-dependent malignant diseases (for example, genital or mammary glands)

Unexplained vaginal bleeding

Hypersensitivity to any of the components of the drug

Drug Interactions

When prescribing concomitant therapy, the drug interactions section of each prescribed drug should be reviewed to identify potential interactions.

Effects of other drugs on Janine â

Interactions with drugs that induce liver enzymes are possible, which may increase the clearance of sex hormones and lead to breakthrough bleeding and / or a decrease in the contraceptive effectiveness of the drug.

Enzyme induction can be observed after a few days of treatment. Maximum enzymatic induction usually occurs within a few weeks. After stopping treatment, enzyme induction may persist for up to 4 weeks.

Short course of treatment

For women on a short course of treatment with liver enzyme-inducing drugs, it is recommended to use a barrier method of contraception in addition to Jeanine® or choose another method of contraception. In this case, the barrier method of contraception should be used during the period of concomitant use of drugs and within 28 days after their withdrawal. If the period of use of the barrier method of contraception ends later than the pills in the Janine pack, you need to go to the next Janine pack without the usual break in taking the pills.

Long course of treatment

Women on long-term treatment with liver enzyme-inducing drugs are advised to use another reliable, non-hormonal method of contraception.

Substances that increase the clearance of combined oral contraceptives (reducing the effectiveness of combined oral contraceptives due to the induction of liver enzymes), for example:

phenytoin, barbiturates, primidone, carbamazepine and rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

Substances with different effects on the clearance of combined oral contraceptives

When combined with combined oral contraceptives, many inhibitors of HIV / HCV protease and non-nucleoside reverse transcriptase inhibitors can increase or decrease the concentration of estrogens or progestins in blood plasma. These changes may in some cases be relevant.

Therefore, it is necessary to read the instructions for use for medicinal products used in conjunction with Janine to identify potential interactions and prescribe any recommendations. Women receiving treatment with protease inhibitors or non-nucleoside reverse transcriptase inhibitors, if in doubt, should use an additional barrier method of contraception

Substances that reduce the clearance of combined oral contraceptives (enzyme inhibitors)

The clinical significance of potential interactions with enzyme inhibitors is unknown.

Co-administration with potent CYP3A4 inhibitors may increase plasma concentrations of estrogen or progestin, or both.

Etoricoxib at a dose of 60 to 120 mg / day increases the concentration of ethinylestradiol in plasma by 1.4-1.6 times when taken simultaneously with combined hormonal contraceptives containing 0.035 mg of ethinylestradiol.

Effect of Janine® on other drugs

Combined oral contraceptives can affect the metabolism of other drugs, resulting in an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in their plasma and tissue concentrations.

However, based on the data of in vitro studies, it is unlikely that the inhibition of enzymes of the cytochrome P450 system will develop when dienogest is prescribed at a therapeutic dose.

Clinical data suggest that ethinylestradiol inhibits the clearance of CYP1A2 substrates, resulting in mild (eg, theophylline) or moderate (eg, tizanidine) elevations.

Other forms of interaction

Laboratory tests

The use of contraceptive steroids may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma concentrations of proteins, for example, corticosteroid-binding globulins and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and coagulation parameters. Changes usually do not go beyond the boundaries of normal values.

special instructions

The decision to prescribe Jeanine should be made on an individual basis, taking into account the woman's risk factors, in particular the development of venous thromboembolism and the assessment of the risk of developing venous thromboembolism while taking Jeanine in comparison with other combined hormonal contraceptives.

Precautions and Warnings

If any of the conditions / risk factors listed below are currently present, it is necessary to discuss with the woman the advisability of using Jeanine.

In the event of an increase or first manifestation of any of these conditions or risk factors, the woman should consult her physician, who may decide whether to discontinue Jeanineâ.

If venous thromboembolism (VTE) or arterial thromboembolism (ATE) is suspected or confirmed, combined hormonal contraceptives should be discontinued. If a woman is prescribed anticoagulant therapy, adequate contraception by an alternative method should be provided, given the teratogenic effect of anticoagulant therapy (coumarins).

· Circulatory disorders

Risk of venous thromboembolism

The use of any combined hormonal contraceptive increases the risk of VTE in patients compared to women who do not use them.

Preparations containing levonorgestrel, norgestimate and norethisterone have the lowest risk of developing VTE. It is not known how much risk Jeanine has compared to these low risk drugs.

The decision to use these drugs, rather than any other low-risk VTE drug, should only be made after discussion with the woman. This is necessary to ensure that the woman is aware of the risks of developing VTE with Jeanine and how her risk factors will affect this risk, and that the risk of VTE is maximum in the first year of use.

In addition, there is some evidence that an increased risk may occur when a combined oral contraceptive is restarted after a break of 4 weeks or more.

In women who do not use combined hormonal contraceptives and in the absence of pregnancy, VTE develops at a rate of 2 per 10,000 cases over 1 year. However, this risk can increase significantly depending on each woman's individual risk factors (see below).

The results of epidemiological studies have shown that among women using low-dose combined hormonal contraceptives (<0,05 мг этинилэстрадиола ВТЭ возникает у 9–12 из 10 000 женщин) в течение года.

It is estimated that out of 10,000 women taking combined hormonal contraceptives containing levonorgestrel, 6 cases develop VTE within 1 year.

Limited data from epidemiological studies suggest that the risk of VTE with CHCs containing dienogest may be similar to the risk with CHCs containing levonorgestrel.

The indicated incidence of VTE during the year is lower than expected during pregnancy and in the postpartum period.

Venous thromboembolism can be fatal in 1-2% of cases.

In women taking combined hormonal contraceptives, cases of thrombosis of other blood vessels, such as hepatic, mesenteric, renal, cerebral arteries and veins, as well as retinal vessels, have been extremely rarely reported.

Risk factors for venous thromboembolism

The risk of developing venous thromboembolic complications while taking combined hormonal contraceptives can increase significantly if a woman has additional risk factors, especially if there are multiple risk factors.

Zhanin's appointment is contraindicated if a woman has multiple risk factors that cause a high risk of developing venous thrombosis.

Consideration should be given to the possibility of an increased synergistic risk of thrombosis in women with a combination of several risk factors or a higher severity of one of the risk factors. In such cases, the increased risk may be greater than just the combined risk when all factors are considered. Combined hormonal contraceptives should not be prescribed in case of a negative risk/benefit ratio (see section "Contraindications").

Symptoms of venous thromboembolism (deep vein thrombosis and pulmonary embolism)

Symptoms of deep vein thrombosis include the following:

unilateral swelling in the leg or along a vein in the leg, pain or discomfort in the leg only in an upright position or when walking, a local increase in temperature in the affected limb, redness or discoloration of the skin on the leg.

Symptoms of pulmonary embolism are as follows: the sudden onset of unexplained shortness of breath or rapid breathing, a sudden attack of coughing, which may be accompanied by hemoptysis, severe chest pain, which may increase with deep breathing, anxiety, severe dizziness; fast or irregular heartbeat.

Some of these symptoms (eg, "shortness of breath" and "cough") are nonspecific and may therefore be misinterpreted as signs of more frequent and less severe disorders (eg, respiratory tract infections).

Other signs of vascular occlusion may include the following:

Sudden pain, swelling and blueness of the limb.

Occlusion of the vessels of the eyes may cause blurred vision, which may progress to loss of vision. In some cases, almost sudden loss of vision may occur.

Risk of arterial thromboembolism

Data from epidemiological studies indicate an increased risk of developing ATE (myocardial infarction) or cerebrovascular disorders (eg, transient ischemic attacks, stroke).

Arterial thromboembolic processes can be fatal.

Risk factors for ATE

The risk of developing arterial thromboembolic complications or cerebrovascular disorders while taking combined hormonal contraceptives increases if a woman has risk factors.

Zhanin's appointment is contraindicated if a woman has one significant factor or multiple risk factors that cause a high risk of developing arterial thrombosis.

Consideration should be given to the possibility of an increased synergistic risk of thrombosis in women with a combination of several risk factors or a higher severity of one of the risk factors.

In such cases, the increased risk may be greater than just the combined risk when all factors are considered. Combined oral contraceptives should not be prescribed in case of a negative risk/benefit ratio (see section "Contraindications").

Symptoms of arterial thromboembolism

If the following symptoms appear, a woman should urgently pay attention to this and inform the doctor that she is using combined hormonal contraceptives.

Symptoms of cerebrovascular disorders may include:

sudden weakness or numbness of the face, upper and lower extremities, especially on one side of the body, sudden confusion, impaired speech or difficulty with perception; sudden blurred vision in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination, sudden severe or prolonged headache for no apparent reason, loss of consciousness or fainting with or without a seizure. Other signs of vascular occlusion can also be sudden pain, swelling or slight cyanosis of the extremities, symptoms of "acute abdomen".

Symptoms of myocardial infarction include:

pain, discomfort, pressure, heaviness, a feeling of constriction or fullness in the chest, in the arm or behind the sternum, a feeling of discomfort radiating to the back, cheekbones, larynx, arm, stomach, a feeling of fullness or fullness in the stomach, a feeling of suffocation, cold sweat, nausea , vomiting or dizziness, severe weakness, anxiety, shortness of breath, rapid or irregular heartbeat.

Risk factors for venous and arterial thromboembolism

The risk of developing thrombosis (venous and / or arterial), thromboembolic or cerebrovascular disorders increases:

With age (over 35 years);

Smokers (women should stop smoking if they intend to take COCs. Other methods of contraception are strongly recommended for women over 35 who continue to smoke);

If there is a family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at a relatively young age before 50 years). If a hereditary predisposition is known or suspected, a woman should consult a doctor to decide on the possibility of taking combined oral contraceptives;

Obesity (body mass index more than 30 kg/m2). The risk increases with increasing BMI. It is especially important to consider the presence of other risk factors;

With dyslipoproteinemia;

With arterial hypertension;

With migraine;

With diseases of the heart valves;

With atrial fibrillation;

With prolonged immobilization, major surgery, any operation on the legs or major trauma. In these situations, it is advisable to stop the use of combined oral contraceptives (in the case of a planned operation, at least four weeks before it) and not resume taking within two weeks after the end of immobilization. Temporary immobilization, including air travel longer than 4 hours, may increase the risk of VTE, particularly in women with other risk factors.

To prevent an unplanned pregnancy, you must use another method of contraception.

If Jeanine has not been discontinued in advance, antithrombotic therapy should be considered.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.

Consideration should be given to the increased risk of thromboembolism during pregnancy and especially during the 6 weeks postpartum period.

Circulatory disorders can also be seen in tumors, diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

An increase in the frequency and severity of migraine during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these drugs.

The most significant risk factor for developing cervical cancer is a viral infection - persistent human papilloma (HPV). There are reports of some increase in the risk of developing cervical cancer with long-term use of combined oral contraceptives, but data remain conflicting about the extent to which this may be due to other factors, including screening for cervical pathology and characteristics of sexual behavior ( less frequent use of barrier methods of contraception).

A meta-analysis of 54 pharmaco-epidemiological studies demonstrated that there is a slightly increased relative risk (RR=1.24) of developing breast cancer diagnosed in women who are currently taking combined oral contraceptives. The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of cases of breast cancer in women who are currently taking combined oral contraceptives or have recently taken it is insignificant in relation to the overall risk of developing this disease. Its relationship with the use of combined oral contraceptives has not been proven. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives, the biological effects of combined oral contraceptives, or a combination of both factors. In women who have ever used combined oral contraceptives, earlier stages of breast cancer are detected than in women who have never used them.

In rare cases, against the background of the use of combined oral contraceptives, the development of benign liver tumors and, in even more rare cases, the development of malignant liver tumors was observed. In some cases, liver tumors can lead to life-threatening intra-abdominal bleeding. In case of severe pain in the upper abdomen, liver enlargement or signs of intra-abdominal bleeding in women taking combined oral contraceptives, the possibility of a liver tumor should be considered in the differential diagnosis.

Malignant tumors can be life-threatening or fatal.

Other states

Women with hypertriglyceridemia (or a family history of this condition) may be at an increased risk of developing pancreatitis while taking Janine.

Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking Janine®, this drug should be discontinued and treatment of arterial hypertension should be started. Reception of Janine® can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.

The following conditions observed during pregnancy may also appear or worsen when taking combined oral contraceptives: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. However, the relationship between the development of these conditions and the use of combined oral contraceptives has not been proven.

In women with hereditary angioedema, exogenous estrogens contained in the drug may provoke or exacerbate the symptoms of this disease.

In the presence of acute or chronic disorders of liver function, it is necessary to resolve the issue of discontinuing the use of combined oral contraceptives until liver function returns to normal. With the development of recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, you should stop taking combined oral contraceptives.

Although combined oral contraceptives may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (<0,05 мг этинилэстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема препарата Жанин®.

Against the background of the use of combined oral contraceptives, manifestations of Crohn's disease and nonspecific ulcerative colitis, as well as worsening of endogenous depression and epilepsy, were observed.

Occasionally, chloasma may develop, especially in women with a history of chloasma of pregnancy. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Women with a tendency to develop chloasma should avoid prolonged sun exposure and UV exposure while taking Janine®.

One tablet of Janine® contains 27 mg of lactose and 1.65 mg of glucose. In patients with rare hereditary disorders such as galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, who are on a lactose-free diet, the amount of lactose contained in the preparation should be taken into account.

Medical examinations

Before or resuming the intake of Jeanine, you should familiarize yourself in detail with the patient's medical history, including family history, and exclude pregnancy. Blood pressure should be measured and a physical examination should be performed, taking into account contraindications and warnings (see section "Special Instructions").

It is very important to draw the woman's attention to information about arterial and venous thromboembolism, including the risk of blood clots when taking Janine® in comparison with other CHPs; symptoms of venous and arterial thromboembolism; known risk factors and what to do if thrombosis is suspected.

The woman should be instructed to carefully read the instructions for use of the drug and follow the recommendations indicated in it.

The frequency and nature of examinations should be based on established practice guidelines and should be determined on an individual basis for each woman.

A woman should be warned that hormonal contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of combined oral contraceptives may be reduced by missing pills, gastrointestinal disturbances, or drug interactions.

Effect on the menstrual cycle

While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy. It may include curettage.

Some women may not develop withdrawal bleeding during their pill break. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if previously combined oral contraceptives were taken irregularly or if there are no consecutive withdrawal bleedings, pregnancy should be excluded before continuing to take the drug.

Pregnancy and lactation

Janine® is not prescribed during pregnancy.

If pregnancy is detected while taking the drug, you should immediately stop taking it. However, extensive pharmaco-epidemiological studies have not revealed any increased risk of developmental defects in children born to women who received combined oral contraceptives before pregnancy or teratogenicity when combined oral contraceptives were taken through negligence in early pregnancy.

Animal studies have shown undesirable effects of the drug during pregnancy and lactation. Based on the data obtained in the course of these animal studies, an undesirable effect associated with the hormonal action of the active compounds of the drug cannot be excluded. However, general experience with combined oral contraceptives during pregnancy does not indicate actual adverse effects in humans.

An increased risk of developing venous thromboembolism should be taken into account when resuming Zhanin® in the postpartum period (see section "Special Instructions").

Lactation

Taking combined oral contraceptives affects lactation because they can reduce the amount of breast milk and change its composition. A small amount of sex steroids and / or their metabolites can be excreted in milk while taking combined oral contraceptives and affect the child's body.

Therefore, Jeanine® should not be used until the nursing mother has completely weaned her baby.

Children and teenagers

The drug Janine® is indicated only after the onset of menarche.

Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms.

No research has been done.

The use of the drug does not affect the ability to drive vehicles and potentially dangerous mechanisms.

Overdose

The acute toxicity of ethinyl estradiol and dienogest is very low. For example, if a child accidentally takes several Jeanine® tablets at the same time, it is unlikely that this will lead to the development of symptoms of intoxication.

Symptoms: Nausea, vomiting and, in young girls, minor vaginal bleeding.

Shelf life

Do not use after the expiration date.

Terms of dispensing from pharmacies

On prescription

Manufacturer

Bayer Weimar GmbH & Co.KG, Germany

Content

Planning a life scenario is often associated with the need to use contraceptive measures. If the choice is made in favor of oral methods (tablets), then it is important to take the safest possible remedy. Many gynecologists advise a long-standing and time-tested drug with the trade name Janine. The tool gently regulates the natural processes of the woman's body, preventing conception. Before use, you must carefully read the instructions.

Composition and form of release

The drug Jeanine (Jeanine) is presented on the pharmaceutical market in the form of white, smooth dragees, which are packaged in 21 pieces in blisters (one or three in a carton). Composition of the product:

Pharmacological properties

Zhanin's instructions for use contain information that the dragee inhibits the secretion of gonadotropic pituitary hormones, inhibits the maturation of follicles and leads to the arrest of ovulation. Taking pills increases the viscosity of the mucus filling the cervical canal, which makes it difficult for sperm to enter the uterine cavity. Dragee normalizes the menstrual cycle, reduces the pain of menstruation and the intensity of discharge, which reduces the risk of developing iron deficiency anemia.

The progestogen component of dienogest is a derivative of nortestosterone, which has antiandrogenic activity, tested in patients with acne. The substance increases the concentration of high-density lipoproteins in the blood, is rapidly absorbed from the stomach. The component reaches its maximum concentration after 2.5 hours, has a 96% bioavailability.

About 10% of the accepted dose of dienogest is stored in free form, the rest binds to albumin. Due to the fact that the component does not bind to transport proteins, it does not displace testosterone and cortisol. The substance has a slight effect of the first passage, it forms inactive metabolites. The half-life is 9-10 hours, 85% of the dose is excreted in 6 days.

Ethinylestradiol is similarly rapidly absorbed in the stomach, reaches a maximum concentration after 1.5-4 hours, undergoes the effect of the first passage through the liver. This explains its low (44%) bioavailability. In the blood plasma, only 1.5% of the substance is in the free state, the rest binds to albumin. The half-life of ethinylestradiol is 10 hours, after three cycles of use it rises to 15 hours. 40% of the product is excreted in the urine, the rest - in the intestines.

Indications for use

Taking the drug Jeanine is indicated for women for the implementation of reliable hormonal contraception, as well as for endometriosis. In addition to the main purpose, the medication is used to treat acne, both during an exacerbation and in a chronic course. Jeanine targets diseases such as hirsutism (male pattern hair), seborrhea and androgenetic alopecia (fragmentary hair loss).

How to take Jeanine

Jeanine birth control pills, according to the instructions, should be used regularly. If you break the regimen for taking pills, this will lead to intermenstrual bleeding and reduce the contraceptive effectiveness of the drug. Tablets are taken every day, washed down with water. The order of administration is indicated on the package. The application cycle lasts 21 days, followed by a week off. On the second or third day, menstrual-like bleeding begins.

How to take Janine for the first time

According to the instructions, if the drug Janine is used for the first time, and the woman has not previously taken any hormonal drugs, then they start drinking dragees from the first day of the menstrual cycle (the first day of bleeding). If you start taking it from day 2-5 of the cycle, then in the first week after taking the first pill, you should use barrier methods of contraception.

Switching from other contraceptives

According to the instructions, if a woman switches to taking Zhanin from other combined hormonal drugs, then taking the dragee begins the day after the last use of the previous drug. The medication should be taken no later than the next day when using contraceptives (21 pills) or after using placebo pills (28 pcs.). When switching from a progestogen drug, dragees are taken on any day when switching from a mini-pill, from the day of the next injection or on the day the implant is removed. During the week you need to use barrier contraceptives.

Taking pills after childbirth or abortion

Hormonal pills Janine, according to the instructions, can be taken immediately after the termination of pregnancy in the first 13 weeks. In this case, additional protection is not needed. When a pregnancy is terminated at a period of 14-27 weeks or after the completion of its birth, the pills are taken on the 21-28th day of the cycle. If taken later in the first week, additional condoms must be used. If there was sexual intercourse between taking the pills and childbirth or abortion, before taking the medicine, you need to make sure that there is no pregnancy or wait for the first menstruation.

Missing pills

If the interval between taking the drug exceeds 12 hours, this will reduce the contraceptive effect. It is impossible to allow intervals between taking contraceptives for more than a week, because during this time the activity of the pituitary-hypothalamus-ovarian system is completely restored. If a delay of more than 12 hours occurred in the first two weeks of taking Jeanine, the next dose is taken immediately, as the woman remembered the pass (you can take 2 pieces at the same time).

Condoms are used for the first week. The more pills missed, the closer the pass is to the standard weekly break, the higher the risk of becoming pregnant. If a dose is missed for more than 12 hours from 15-21 days of administration, then it should be taken as soon as possible, even if the intake involves 2 tablets at the same time. Then the medicine is taken as usual. For the next seven days, condoms must be used for contraception, and at the end of the package, immediately start the next one, without enduring seven days of “rest”.

In this case, bleeding when taking Janine will not begin until the second package is completed, but spotting and breakthrough bleeding may occur during the reception. If after skipping the pills in the seven-day period free from taking pills, there is no bleeding when taking the pills, this may indicate a pregnancy. Prolonged vomiting (lasting 3-4 hours) can reduce the absorption of the active substances of the drug. In such a situation, you need to take pills, as in the case of a pass.

If a woman has no intention of changing the usual pill intake pattern, you can take several additional pills from the next package to delay the onset of menstruation. You can even finish the whole pack, but after that you must definitely take a seven-day break.

Jeanine for endometriosis

Doctors have not yet established the exact cause of endometriosis. It is only known that some cases are caused by a malfunction of hormonal function. In the second phase of the cycle after ovulation, the organs of the reproductive system are intensively preparing for pregnancy, the uterine mucosa grows. The use of Zhanin does not allow ovulation to occur (the release of an egg from the ovary), therefore, it reduces the severity of post-ovulation changes in the endometrium of the uterus.

Gynecologists prescribe pills for endometriosis to relieve pain, normalize the disturbed cycle, reduce the intensity of bleeding and the severity of other symptoms of the disease. In a healthy woman, bleeding during menstruation is due to rejection of the uterine mucosa, with endometriosis this is accompanied by vascular damage. The dragee does not allow the endometrium to actively grow, become inflamed, and compress the nerve trunks.

The effectiveness of the drug has been proven in genital and extragenital endometriosis. The components of the composition are highly active, which allows them to be used in a minimum dosage. There are several schemes for taking pills for endometriosis, the choice of method is up to the doctor. Popular is the standard use of tablets for three cycles. After that, the patient takes tests for blood clotting, the biochemical composition of the plasma, the state of the liver and foci of endometriosis.

Another scheme of application, according to the instructions, is the continuous intake of tablets for 63-84 days in a row, after which a week break is taken. Due to the fact that during the treatment one instead of 3-4 menstruation passes, the patient's condition improves. According to doctors, the use of Jeanine in endometriosis is effective in 85% of cases. Patients note rare side effects and good tolerability.

Until what age can you take Jeanine?

Instructions for the use of tablets do not limit the age of use of contraceptives, except for the period when menopause occurs. Every woman has her own line. After the onset of menopause, the pills are ineffective, they can cause serious problems with the functioning of the reproductive organs. Similarly, you can not take the medicine before the onset of menstruation.

drug interaction

The instructions for use of Jeanine talk about the drug interaction of the drug with other medicines. This can cause negative reactions:

1. Barbiturates, Rifampicin, hydantoins, Carbamazepine, Topiramate, Parimidon, Felbamate, Griseofulvin can reduce the contraceptive effect of the drug.
2. Ampicillins and tetracyclines can lower the concentration of ethinylestradiol.
3. At the end of the course of Rifamzpin, you should additionally use contraceptive measures within a month after the end of the intake.

special instructions

When prescribing the drug, one must take into account the risk of signs of intra-abdominal bleeding, an increase in the size of the liver (up to the appearance of tumors), and abdominal pain. The period of adaptation to the drug is three cycles, during which irregular bleeding (both in the form of a breakthrough and spotting) is possible. Such bleeding can occur and recur after regular cycles have ended if there is a non-hormonal cause. The use of Jeanine increases the risk of thrombosis, especially in women who smoke over 35 years of age.

According to the instructions, when planning a surgical operation, it is required to warn the doctor about oral contraception. With an increase in blood pressure, the doctor decides on the abolition of the medication. With regular use of the drug, it is required to undergo an examination with a doctor at least once a year. Jeanine does not increase resistance to sexually transmitted diseases.

During pregnancy

The available data from epidemiological studies in the instructions indicate that the drug does not increase the likelihood of impaired embryonic development of children in women who took Jeanine shortly before the onset of pregnancy or some time after the onset (out of ignorance of the fact of pregnancy). At the same time, the manufacturer prohibited the use of the drug during the period of bearing a child and during breastfeeding. Hormonal contraceptives suppress lactation and change the composition of breast milk. After the abolition of the dragee, pregnancy occurs in a short time.

Alcohol compatibility

The manufacturer's instructions for the drug do not limit the combination of pills with alcoholic beverages. Many pharmacists allow the simultaneous administration of tablets and alcohol, but in the amount of not more than one glass of wine (20 g of ethanol). Consider the following factors:

• the perception of alcohol by the body individually;
• hormonal contraceptives increase the load on the liver, and together with alcohol, the load increases;
• with high activity of liver enzymes, provoked by high doses of alcohol, the disintegration and excretion of the active substances of the drug is accelerated;
• alcohol intoxication, leading to vomiting, leads to the removal of the drug from the gastrointestinal tract, which naturally reduces the effectiveness of the remedy (it is recommended to maintain a 3-hour interval between the use of other drugs and Jeanine).

Side effects of Jeanine

An overdose of the drug is treated symptomatically, there is no antidote. The use of hormonal estrogen-progestin contraceptives may be accompanied by the appearance of side effects indicated in the instructions:

• an increase in the volume and elasticity of the mammary glands, accompanied by pain;
• headache (migraine);
• quick change of emotional mood;
• nausea and vomiting;
• widespread itching;
• abdominal pain;
• jaundice;
• erythema multiforme or nodosum;
• weight fluctuations;
• allergic reactions;
• arterial hypertension;
• decreased libido;
• metabolic pathologies;
• fluid retention in the body;
• violation of visual function;
• circulatory disorders: thromboembolism and thrombosis;
• in rare cases, diarrhea, chloasma (hyperpigmentation), fatigue.

Contraindications

The prohibition of taking the drug is due to the following reasons and conditions of the body indicated in the instructions:

• diabetes mellitus, accompanied by vascular complications;
• arterial and venous thrombosis;
• a history of myocardial infarction;
• HIV infection;
• pathological conditions of the coronary heart arteries;
• diseases of the cerebral vessels, aggravated by a violation of the valvular apparatus of the heart;
• stable arterial hypertension;
• undergone major surgery;
• angina;
• liver failure and severe liver disease;
• pancreatitis complicated by hypertriglyceridemia;
• liver tumors;
• vaginal bleeding of unknown origin;
• migraine with focal symptoms of neuralgia;
• hormone-dependent diseases of the genital organs or mammary glands of a malignant nature;
• pregnancy and breastfeeding period;
• high sensitivity to the constituent components of Jeanine;
• climacteric condition.

Terms of sale and storage

Sale of medication from pharmacies is allowed if the buyer has a prescription. The drug should be stored at a temperature not exceeding 25 degrees, out of the reach of children.

Analogues

Jeanine is not a unique drug, it can be replaced by other oral contraceptives. Popular analogues of the remedy are:

• Belara - combined tablets containing chlormadinone, ethinylesradiol;
• Yarina - birth control pills based on ethinyl estradiol, drospirenone;
• Midiana is a contraceptive containing drospirenone and ethinyl estradiol;
• Logest - combined tablets based on gestodene and ethinyl estradiol;
• Lindinet 30 is a drug based on the sex hormones ethinyl estradiol, gestodene;
• Mercilon is an estrogen-progestogenic agent containing desogestrel, ethinyl estradiol;
• Marvelon - birth control pills based on ethinyl estradiol, desogestrel;
• Femodene is an estrogen-gestagenic drug containing gestodene, ethinyl estradiol;
• Silhouette - a structural analogue of Jeanine, contains the same components in the composition;
• Qlaira - a drug based on dienogest and estradiol valerate, the pack contains 5 types of tablets;
• Visanne - tablets that contain only micronized dienogest.

Jeanine price

The cost of the drug depends on how many pills are included in the package - 21 or 63 (for 1 and 3 cycles). Prices will vary depending on the type of pharmacy. Approximate cost of a drug manufactured by Bayer in Moscow.