Siofor 800 instructions for use. Siofor: how to take, what to replace, contraindications. Early use

01.09.2020 Complications

In order to lose weight, in the overwhelming majority of cases, a lot of effort is required. Some people manage to lose those extra pounds with the help of special diets and increase physical activity... For others, losing weight is a long-term process that requires not only willpower, but also the use of special drugs.

In cases where weight loss is suspended, and the process cannot be activated with the help of an active lifestyle and food restrictions, you can use modern drug- Siofor.

Siofor tablets are a means that is designed to reduce body weight in cases where other drugs for weight correction have not had an effect, or when other measures do not give an effect (increased sports and strict diets).

Siofor is a medication that includes a special powerful component - metamorphine hydrochloride. This substance is classified as glucose-lowering drugs (biguanide class).

In the treatment of diabetes mellitus, Siofor is used both for monotherapy and as part of a complex (other tablets that regulate sugar or insulin levels). The drug is prescribed for the treatment of diabetes and for its prevention, and it is considered the safest drug.

reference ... Metamorphine hydrochloride is prescribed for the treatment of patients with diabetes mellitus (type 2), usually in the composition complex therapy... Substance metamorphine showed good therapeutic effect in patients who were overweight (high and medium degree obesity), but did not have renal impairment.

Metamorphine hydrochloride:

  • Helps reduce the production of sugar in the liver.
  • Activates the consumption of glucose by muscle mass.
  • Reduces appetite.
  • Reduces the absorption of carbohydrates in the intestines.

Result:

  1. Decreased appetite and decreased food intake.
  2. Decreased cravings for sweets.
  3. The disappearance of bouts of hunger.
  4. Facilitating the passage of diet courses.
  5. Reducing the total calorie intake of the daily diet without feeling stress.
  6. Limiting the consumption of carbohydrate foods.

According to experts, thanks to an integrated approach - the use of Siofor according to the instructions, as well as the use of a specially selected low-carbohydrate diet and active sports, it is possible to ensure fast and safe weight loss for health.

Obesity, which appeared against the background of chronic overeating, as well as concomitant pathologies that became its consequence, are the result of the deposition of excess lipids in the body. This leads to a decrease in the sensitivity of tissue cells to the hormone insulin, and then, over time, to the development of diabetes mellitus. In such cases, the reception of special medications- a mandatory therapeutic measure.

Attention! Medicine Siofor is intended to restore insulin sensitivity, and rapid decline body weight is a consequence of the normalization of this sensitivity.

Those people who do not have type 2 diabetes, but suffer from overweight caused by some other reason, often use a variety of medications to correct weight at their discretion.

These are various drugs, including the popular Siofor in recent years, since many have heard about its high effect, relative safety and the ability to quickly and allegedly easily get rid of extra pounds.

We draw your attention to the fact that this drug helps to lose weight in many cases, but doctors are against taking the drug without consulting a specialist, an accurate diagnosis and a series of examinations.

Method of administration and dosage

Inside one tablet with meals, once a day.

Drink plenty of water - at least a glass of clean water. The remedy is best taken in the morning during breakfast.

If you have a strong craving for sweets and need to eat at night: Add another Siofor tablet during dinner.

Lightweight, low-calorie.

If it is difficult to follow a low-calorie diet: Take three Siofor tablets per day, with breakfast, lunch and dinner.

During the course of treatment:

  • Eliminate high-carb foods (alcohol, baked goods, candy, chocolate, pasta, potatoes).
  • Give up fast food completely.
  • Do not use sugar, sugary carbonated drinks.

Feature of Siofor for weight loss

The active ingredient of the drug reduces the absorption of sugars in the intestines. If a large amount of carbohydrates is present in the daily diet, a disorder of the digestive tract inevitably occurs, which leads to diarrhea.

special instructions

Before you start taking it, you should:

  1. Examine kidney function. During the course of treatment with the drug, kidney tests are performed every six months, and also within six months after the end of treatment.
  2. During the course of therapy, one should not (especially in the first month or two) engage in activities that require increased concentration of attention.
  3. It is forbidden to take the drug together with medicines containing iodine.
  4. You can not take Siofor two days before the X-ray examination and within two hours after it.
  5. Reception is prohibited alcoholic beverages during treatment, especially at the time of taking the pill. If this is not possible, then alcohol is taken at least 3-4 hours after the pill or two hours before it.

Analogs

The main component of the drug can also be found in other drugs (Bagomet, Formetin, Langerin, Metadien, Sofamet, etc.). However, some of these drugs have a prolonged effect.

Glucophage Long and Siofor. In the first case, the action occurs in 8-10 hours, it is softer, in the second - within half an hour. Glucophage is taken only once a day, has a prolonged effect and at the same time controls the glucose level at night.

Siofor is prescribed instead of Glucophage, usually in cases where side effects were observed from taking Glucophage. Glucophage is more expensive than Siofor, because Siofor with active ingredient metformin is more popular. The price of Glucophage is higher, since it is an analogue, an original medicine from Menarini-Berlin Chemie (Germany), whose specialists found this active ingredient and first released it on the market.

How to find the optimal dose?

Drink Siofor 500 mg, 850 mg or 1000?

  1. Taking the drug, using a special diet and playing sports.

Dose: 500 mg, taken twice a day.

Result: weight loss of about two kilograms in seven to ten days.

  1. Increasing the dose. Consultation with a dietitian is required. In some cases, additional medical examinations and consultations with related specialists are required (endocrinologist, gynecologist, laboratory tests, instrumental studies). Do not adjust the dosage yourself!

Admission course

Determined by a doctor. For healthy person, in whom the doctor found no contraindications and allowed the drug to be taken, the course should not be more than three months.

Overdose symptoms

Overdose symptoms are reminiscent of common food poisoning.

Treatment is symptomatic. Help is a sweet reception.

Contraindications and side effects

Metamorphine hydrochloride, which is part of the Siofor drug, is a substance used to treat diabetes mellitus. This is not a dietary supplement, but medicinal product, therefore, the question of its independent appointment and selection of the dosage is not worth it at all.

The active component of the drug has a whole list of contraindications and negative side effects. With an illiterate prescription, the patient may develop irreversible changes.

Contraindications:

  • The presence of insulin-dependent diabetes mellitus (type 1).
  • Hypersensitivity to the components of the product.
  • Impaired renal function.
  • High body temperature of various etiologies.
  • Dehydration of the body.
  • Ketoacidosis
  • Severe liver disease.
  • Coronary insufficiency.
  • Respiratory dysfunctions.
  • Severe infectious diseases.
  • Surgical operations and mechanical trauma.
  • Malignant and benign neoplasms.
  • Use of a super low-carb diet (less than 1,000 kcal / day).
  • Chronic alcoholism.
  • Drug addiction and any other addiction.
  • Pregnancy.
  • Lactation.
  • Children and adolescents.
  • Elderly age (after 60 years).

Side effects characteristic in the initial period of treatment:

  • Gastrointestinal dysfunction (nausea / vomiting / diarrhea).
  • Sharp abdominal pain.
  • Anemia (drop in hemoglobin levels).
  • Lactic acidosis.
  • Foreign taste in the mouth (metallic).
  • Allergic skin reactions.

Dysfunction of the gastrointestinal tract does not require discontinuation of the drug and usually goes away on its own after a while.

  1. Dramatically reduces the need for sweets. This action is due to a decrease in the body's production of the hormone insulin. It is because of insulin that a person feels hypoglycemia, which does not go away until the body receives a dose of sweets. In severe cases of hypoglycemia, symptoms characteristic of a reduced amount of glucose in the blood are observed - trembling of the limbs, weakness, cold sweat and even loss of consciousness (coma).
  2. Reduces the number and severity of hypoglycemic attacks. Because of the hormone insulin, an "overdose" of sweets occurs when the patient is unable to give up cakes, rolls and chocolate. Insulin "forces" the body to store excess fat. When Siofor is taken, insulin sensitivity rapidly increases, therefore the body does not need to produce this hormone in increased amounts... And if you approach the issue of losing weight competently and comprehensively and apply specially selected low-calorie diets, then the extra pounds go away pretty quickly.
  3. With the course of treatment with the drug and not following the diet, weight is also lost, but much more slowly. Weight loss occurs, but this requires more time, since active ingredient the drug still blocks the absorption of carbohydrates that come with food. Excess carbohydrates are removed from feces, without being deposited in the body, however, this process is accompanied by active fermentation in the gastrointestinal tract, the formation of a large amount of gas, bloating, pain in the intestines, reminiscent of newborn colic. At the same time, the stool becomes frequent, acquires a liquid consistency and a sour smell.

Endocrinologist opinion

Weight loss while taking Siofor is like by-effect funds. There are patients who may experience weight loss (to varying degrees), but there are times when there is none at all.

1 coated tablet contains metformin hydrochloride 500 mg

Excipients: povidone (K value = 25), hypromellose, magnesium stearate, titanium dioxide (E 171), macrogol 6000.

Release form

Film-coated tablets.

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Pharmacological group

Antidiabetic drugs. Oral hypoglycemic drugs. ATC code: А10 BA02

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Pharmacological properties

Pharmacological. Metformin is a glucose-lowering biguanide that reduces both basal and postprandial blood sugar levels. Metformin does not stimulate insulin secretion and therefore does not lead to hypoglycemia. The sugar-lowering effect is due to several mechanisms: an increase in muscle sensitivity to insulin and, accordingly, a decrease in glucose uptake at the periphery and its utilization; a decrease in the production of glucose in the liver due to inhibition of gluconeogenesis and glycogenolysis; inhibition of glucose absorption in the intestine. Metformin with its direct action on glycogen synthetase stimulates intracellular glycogen synthesis. Metformin increases the glucose transport capacity of all hitherto known membrane transport proteins (GLUTs). Metformin leads to a decrease in total cholesterol, low-density cholesterol and triglycerides.

Pharmacokinetics. After an orally taken dose of metformin, its maximum concentration (T max) is reached after 2.5 hours. Bioavailability is 50-60%. When taken orally, the fraction that is not absorbed and excreted in the feces is 20-30%. When taken orally, the absorption of metformin is incomplete and has a satiety character. Metformin is believed to have non-linear pharmacokinetics. At the recommended dosages and at usual dosing intervals, equilibrium relative to plasma concentrations is achieved after 24 to 48 hours. The latter are usually less than 1 mg / ml. The maximum concentration of metformin in plasma (C max) at the maximum dosage does not exceed 4 mg / ml. Food intake reduces and slightly inhibits the absorption of metformin. Plasma protein binding is negligible. Metformin is excreted unchanged in the urine. After administration, the half-life is approximately 6.5 hours. With a decrease in renal function, renal clearance decreases in proportion to creatinine clearance, after which the half-life is lengthened and the concentration of metformin in plasma increases.

Indications

Diabetes Type II in adults, especially in overweight patients, in whom sufficient blood sugar adjustment is not achieved with diet and exercise.

Method of administration and dosage. Monotherapy and combination with other oral hypoglycemic agents. Of course, the initial dose of Siofor - 500 - 1 coated tablet, which is taken 2 or 3 times a day during or after meals. After 10 - 15 days, the dose should be adjusted depending on the blood sugar levels. The gradual increase in the dose has a positive effect on the tolerability of the medication. Maximum daily dose is 3 g of metformin per day. When transferring a patient from another oral antidiabetic agent to metformin, the previous medication should be discontinued first and then metformin therapy should be started. Combination with insulin. Metformin and insulin can be combined to increase blood sugar correction. Metformin is given at the usual starting dose, while the insulin dose depends on the measured blood sugar values. Elderly patients. Due to the often limited renal function in elderly patients, the dose of metformin should be selected based on renal function.

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Side effect

Digestive tract complaints. Nausea, vomiting, diarrhea, abdominal pain and loss of appetite are very common (> 10%). Often (1% - 10%) there is a metallic taste in the mouth. Functional disorders from the skin and subcutaneous tissue. Very rarely (<0,01%) наблюдается незначительная эритема у больных с повышенной чувствительностью. Нарушение обмена веществ. Очень редко (<0,01%) - снижение всасывания витамина В 12 , вплоть до снижения его концентрации в сыворотке крови при длительном применении. Очень редко (0,03 случаев / 1000 пациентов в год) наблюдается лактатацидоз.

Contraindications

Hypersensitivity to metformin or other components of the drug diabetic ketoacidosis and diabetic coma; renal failure or impaired renal function (serum creatinine values> 135 μmol / L in men and 110 μmol / L in women); acute conditions that can lead to deterioration of renal function, for example, dehydration, severe infection, shock, intravascular administration of iodine-containing contrast compounds; acute or chronic diseases that can lead to tissue hypoxia, for example, heart or respiratory failure, fresh myocardial infarction, shock, liver failure, acute alcohol intoxication; alcoholism, lactation period.

Overdose

At a dosage of up to 85 g, hypoglycemia was not noted, even if lactic acidosis developed under these conditions. With a significant overdose or in the presence of concomitant risk factors, lactic acidosis may develop. In this case, an emergency hospitalization of the patient is required. The most effective method for removing lactate and metformin is hemodialysis.

Application features

Patients with diabetes who wish to become pregnant or are already pregnant should not be treated with metformin. In the absence of sufficient clinical experience of use, it is not recommended to prescribe Siofor â 500 to children. The drug Siofor â 500 is prescribed as monotherapy, in combination with other oral hypoglycemic agents or insulin. Siofor â 500 therapy is possible under the condition of normal renal function, therefore, before starting treatment, as well as during treatment, it is necessary to regularly monitor the level of creatinine in the blood serum. Patients with normal renal function - once a year, and elderly patients and those with creatinine levels on the verge of normal - 2-4 times a year. Particular care is required when renal function is limited, for example at the beginning of treatment with antihypertensive drugs, diuretics, or non-steroidal anti-inflammatory drugs. 48 hours before the planned surgical intervention, which will be performed under general anesthesia, Siofor â500 must be canceled. During treatment with metformin, alcohol and the use of drugs that contain alcohol should be avoided, since the latter significantly increases the risk of developing lactic acidosis, especially in combination with fasting, malnutrition and liver failure. Siofor â 500 does not lead to hypoglycemia and therefore does not affect the ability to drive vehicles or mechanical means. However, when combined with other hypoglycemic drugs, there is a risk of hypoglycemia.

Siofor is an oral hypoglycemic drug from the biguanide group that reduces both basal and postprandial blood glucose concentrations.

Release form and composition

Dosage form - white coated tablets:

  • Siofor 500: round, biconvex (10 pcs. In blisters, in a cardboard box 3, 6 or 12 blisters);
  • Siofor 850: oblong, with a double-sided risk (15 pcs. In blisters, in a cardboard box 2, 4 or 8 blisters);
  • Siofor 1000: oblong, with a notch on one side and a wedge-shaped snap-tab on the other (15 pcs. In blisters, in a cardboard box of 2, 4 or 8 blisters).

The active ingredient of the drug is metformin hydrochloride, one tablet contains 500 mg (Siofor 500), 850 mg (Siofor 850) or 1000 mg (Siofor 1000).

Additional components:

  • Excipients: povidone, hypromellose, magnesium stearate;
  • Shell composition: macrogol 6000, hypromellose, titanium dioxide (E171).

Indications for use

Siofor is intended for the treatment of type II diabetes mellitus, especially in overweight patients with ineffective physical activity and diet therapy.

It can be used as a monopreparation or as part of complex therapy in combination with insulin and other oral hypoglycemic agents.

Contraindications

Absolute:

  • Diabetic ketoacidosis, diabetic precoma;
  • Lactic acidosis, including history;
  • Liver failure;
  • Renal dysfunction (creatinine clearance<60 мл/мин) или почечная недостаточность;
  • Acute conditions that can have a negative effect on kidney function (for example, severe infection or dehydration);
  • Chronic alcoholism and acute alcohol intoxication;
  • Acute or chronic diseases that can lead to tissue hypoxia (for example, respiratory or heart failure, recent myocardial infarction, shock);
  • Intravascular administration of an iodine-containing contrast agent;
  • Compliance with a low-calorie diet (consumption of less than 1000 kcal per day);
  • Children under the age of 10;
  • Pregnancy;
  • Lactation period;
  • Hypersensitivity to the components of the drug.

Relative (special care required):

  • Children aged 10-12;
  • Patients over the age of 60 who perform heavy physical work.

Method of administration and dosage

The drug should be taken orally during meals or immediately after.

The dosage regimen and duration of treatment is determined by the doctor depending on the blood glucose level.

When conducting monotherapy, adults are prescribed 500 mg 1-2 times a day or 850 mg 1 time a day. After 10-15 days, if necessary, the daily dose is gradually increased to 3-4 Siofor 500 tablets, 2-3 Siofor tablets 850 mg or 2 Siofor 1000 tablets.

The maximum daily dose is 3000 mg (6 tablets of 500 mg or 3 tablets of 1000 mg) in 3 divided doses.

When prescribing high doses, 2 Siofor 500 tablets can be replaced with 1 Siofor 1000 tablet.

If the patient is transferred to metformin from other antidiabetic drugs, the latter are canceled and Siofor is taken in the above doses.

In combination with insulin (to improve glycemic control) Siofor is prescribed 500 mg 1-2 times a day or 850 mg once a day. If necessary, once a week, the dose is gradually increased to 3-4 Siofor 500 tablets, 2-3 Siofor 850 tablets or 2 Siofor 1000 tablets. The insulin dose is determined depending on the blood glucose level. The maximum daily dose is 3000 mg in 3 divided doses.

Elderly patients, when selecting a dose, also take into account the concentration of creatinine in the blood plasma. During treatment, regular assessment of kidney function is necessary.

Children aged 10-18 years, both for monotherapy and in combination with insulin, are prescribed 500 mg or 850 mg of metformin once a day at the beginning of treatment. If necessary, after 10-15 days, the dose is gradually increased. The maximum daily dose is 2000 mg (4 tablets of 500 mg or 2 tablets of 1000 mg) in 2-3 doses.

The required dose of insulin is determined depending on the level of glucose in the blood.

Side effects

  • Allergic reactions: very rarely - urticaria, itching, hyperemia;
  • Nervous system: often - taste disturbance;
  • Liver and biliary tract: individual reports - a reversible increase in the activity of hepatic transaminases, hepatitis (disappear after discontinuation of the drug);
  • Metabolism: very rarely - lactic acidosis; with prolonged use - a decrease in the absorption of vitamin B 12 and a decrease in its concentration in the blood plasma (the likelihood of this reaction should be taken into account when prescribing the drug to patients with megaloblastic anemia);
  • Digestive system: lack of appetite, metallic taste in the mouth, nausea, vomiting, abdominal pain, diarrhea. These symptoms often occur early in treatment and usually resolve on their own. To prevent them, you should gradually increase the daily dose, divide it into 2-3 doses, and take the drug with meals or immediately after.

special instructions

Siofor is not a substitute for dietary nutrition and daily exercise - these non-drug therapies must be combined with the drug in accordance with the recommendations of the attending physician. All patients should follow a diet with even consumption of carbohydrates throughout the day, overweight people should follow a low-calorie diet.

If you suspect the development of lactic acidosis, immediate withdrawal of the drug and emergency hospitalization of the patient are required.

Metformin is excreted by the kidneys, therefore, before starting treatment and regularly in its process, the concentration of creatinine in the blood plasma should be determined. Special supervision is necessary if there is a risk of impaired renal function, for example, at the beginning of the use of diuretics, non-steroidal anti-inflammatory or antihypertensive drugs.

If it is necessary to conduct an X-ray study with intravenous administration of an iodine-containing contrast agent, Siofor should be temporarily (48 hours before and 48 hours after the procedure) replaced with another hypoglycemic drug. The same must be done when prescribing elective surgery under general anesthesia, epidural or spinal anesthesia.

According to one-year controlled clinical trials, metformin does not affect the growth, development and puberty of children. However, there are no data on these indicators with longer therapy, therefore, children receiving Siofor, especially in the prepubertal period (10-12 years), require special observation.

Siofor monotherapy does not lead to hypoglycemia. With combination therapy (in combination with insulin or sulfonylurea derivatives), there is such a possibility, therefore, care must be taken.

Siofor, used as a monopreparation, does not adversely affect the speed of reactions and / or the ability to concentrate. When using metformin as part of complex therapy, there is a risk of developing hypoglycemic conditions, therefore, care should be taken when engaging in any potentially hazardous activities, incl. when driving vehicles.

Drug interactions

Metformin is contraindicated for use during studies with intravascular administration of iodine-containing contrast agents.

It is not recommended to consume alcoholic beverages and take ethanol-containing drugs during treatment, as the risk of lactic acidosis increases, especially in liver failure, malnutrition or dieting.

Combinations requiring caution due to possible interaction reactions:

  • Danazol - development of a hyperglycemic effect;
  • Angiotensin-converting enzyme inhibitors and other antihypertensive drugs - lowering blood glucose;
  • Thyroid hormones, oral contraceptives, nicotinic acid, glucagon, epinephrine, phenothiazine derivatives - increased blood glucose concentration;
  • Nifedipine - increasing the absorption and maximum concentration of metformin in the blood plasma, prolonging its excretion;
  • Cimetidine - slowing down the elimination of metformin, increasing the risk of developing lactic acidosis;
  • Salicylates, sulfonylurea derivatives, insulin, acarbose - increased hypoglycemic action;
  • Cationic drugs (procainamide, morphine, quinidine, triamterene, ranitidine, vancomycin, amiloride) secreted in the tubules - an increase in the maximum concentration of metformin in blood plasma;
  • Furosemide - a decrease in its concentration and half-life;
  • Indirect anticoagulants - weakening their action;
  • Beta-adrenomimetics, diuretics, glucocorticoids (for systemic and local use) - an increase in blood glucose.

Terms and conditions of storage

Store at temperatures up to 25 ° C out of reach of children.

Shelf life is 3 years.

Siofor is one of the most popular hypoglycemic drugs. The main active ingredient is metformin.

It is prescribed to effectively regulate the amount of concentrated glucose in insulin-dependent diabetics.

It is indispensable if proper nutrition and regular exercise do not help in the fight against weight-increasing glycemia. An equally important advantage of the drug is its ability to effectively reduce the amount of cholesterol; it also provides a unique help in the fight against obesity.

Clinical and pharmacological group

Oral hypoglycemic drug.

Conditions of sale from pharmacies

Can be purchased with a doctor's prescription.

Price

How much does Siofor 500 mg cost in pharmacies? The average price is at 280 rubles.

Composition and form of release

Dosage form - white coated tablets:

  • Siofor 500: round, biconvex (10 pcs. In blisters, in a cardboard box 3, 6 or 12 blisters);
  • Siofor 850: oblong, with a double-sided risk (15 pcs. In blisters, in a cardboard box 2, 4 or 8 blisters);
  • Siofor 1000: oblong, with a notch on one side and a wedge-shaped snap-tab on the other (15 pcs. In blisters, in a cardboard box of 2, 4 or 8 blisters).

The active ingredient of the drug is metformin hydrochloride, one tablet contains 500 mg (Siofor 500), 850 mg (Siofor 850) or 1000 mg (Siofor 1000).

Additional components:

  • Excipients: povidone, hypromellose, magnesium stearate;
  • Shell composition: macrogol 6000, hypromellose, titanium dioxide (E171).

pharmachologic effect

Siofor is a product from Berlin-Chemie AG. This is one of the largest pharmaceutical associations located in Italy. The drug is produced in the form of tablets of various dosages. It can be Siofor 500, 850 and 1000 mg.

The main substance of the drug does not affect the functioning of human beta cells. Due to this, a large amount of insulin is not produced in the body, and therefore hypoglycemia does not develop. The positive effect of the drug is based on the additional components included in the drug, among which are Povidone, Magnesium stearate, Titanium dioxide, Hypromelase and Macrogol 6000.

The unique composition of the drug makes it possible for people taking it to achieve such positive results as:

  1. Slowing down the absorption of active glucose in the digestive organs;
  2. Decrease in the rate of glucose production in the liver;
  3. Improving the general sensitivity of peripheral tissues to sugar-containing hormones.

Siofor in the process of diabetes treatment has a positive effect on the general lipid metabolism, the coagulability of the blood composition is significantly improved. The amount of sugar in the body decreases during the meal, but also before meals.

Patients who take medication and follow a simple diet quickly achieve weight loss.

Indications for use

Siofor can be used as a monotherapy drug or in combination with other oral hypoglycemic agents and insulin.

Contraindications

Absolute:

  • Diabetic ketoacidosis, diabetic precoma;
  • Lactic acidosis, including history;
  • Liver failure;
  • Intravascular administration of an iodine-containing contrast agent;
  • Compliance with a low-calorie diet (consumption of less than 1000 kcal per day);
  • Children under the age of 10;
  • Pregnancy;
  • Lactation period;
  • Renal dysfunction (creatinine clearance<60 мл/мин) или почечная недостаточность;
  • Acute conditions that can have a negative effect on kidney function (for example, severe infection or dehydration);
  • Chronic alcoholism and acute alcohol intoxication;
  • Acute or chronic diseases that can lead to tissue hypoxia (for example, respiratory or heart failure, recent myocardial infarction, shock);
  • Hypersensitivity to the components of the drug.

Relative (special care required):

  • Children aged 10-12;
  • Patients over the age of 60 who perform heavy physical work.

Appointment during pregnancy and lactation

Pregnancy is a contraindication for taking Siofor. The drug is contraindicated during pregnancy. When planning a pregnancy, drug treatment is also not recommended.

Dosage and method of administration

As indicated in the instructions for use, Siofor 500 tablets are taken orally during or after meals. The regimen, the dose of the drug, the duration of the course of therapy, the doctor prescribes individually, taking into account the level of glucose concentration in the blood plasma.

  1. Monotherapy: initial dose - 1 pc. (0.5 g) 1-2 times a day for 10-15 days. Then, taking into account the level of glucose in the blood plasma, the dose is gradually increased to 3-4 pcs. in a day. A gradual increase in the dose avoids symptoms of intolerance from the gastrointestinal tract. The maximum daily dose is 6 pcs. (3d) divided into 3 doses;
  2. Combined therapy with insulin: initial dose - 1 pc. 1-2 times a day. The dose should be increased gradually, at intervals of 7 days. The average daily dose after the increase is 3-4 pcs. Insulin dosage is determined based on blood glucose levels. The daily dose of the drug should not exceed 6 pcs., It should be divided into 3 doses.

The transition from the use of another antidiabetic agent is made by canceling the previous and immediate start of taking Siofor 500 in the above doses.

For elderly patients, the dose of the drug should be prescribed with extreme caution, only taking into account the level of creatinine in the blood plasma. Treatment should take place under regular monitoring of the state of renal function.

The recommended dosage of Siofor 500 for children over 10 years of age with monotherapy and in combination with insulin: initial dose - 1 pc. (0.5 g) once a day. To achieve the desired therapeutic response after 10-15 days of administration, you can begin to gradually increase the dose, depending on the level of glucose in the blood plasma. The maximum daily dose for children aged 10 to 18 years is 4 pcs. (2 g of metformin) in 2-3 doses. Insulin dosage is determined based on plasma glucose levels.

When appointing 4–6 pcs. (2-3 g) per day, you can use tablets of the drug in a dose of 1 g (Siofor 1000).

How to take Siofor 500 for weight loss

The minimum dosage of metformin that is possible for Siofor (according to the range of Russian pharmacies) is 500 mg. The use of such a pill is allowed even in children, and persons who are considering the option of losing weight with Siofor, it is advisable to do with this option. For diabetics, doctors suggest 2 options for using the drug:

  • as monotherapy - 500 mg 2 times a day;
  • combined with insulin (for addiction) - an increase from 500 mg to 2000 mg per day, i.e. from 1 to 4 receptions.

If we talk about how to take Siofor 500 for weight loss, then it is advisable to dwell on the monotherapy option proposed by the official instructions: for a month, drink Siofor 500 tablets, 1 pc. in a day. Do this with food or after taking it, because the use of metformin is fraught with irritation of the gastrointestinal tract. The minimum dosage of Siofor has a mild effect on the process of losing weight, but adverse reactions to it are also rare. With good tolerance, the instruction allows an increase in the dose to 2 Siofor tablets.

Side effect

Possible violations (often - ≥ 1/100,< 1/10; нечасто – ≥ 1/1000, < 1/100; редко – ≥ 1/10 000, < 1/1000; очень редко – < 1/10 000, с учетом отдельных случаев):

  • nervous system: often - taste disturbances;
  • allergic reactions: very rarely - skin reactions, including flushing, itching, urticaria;
  • digestive system: nausea, vomiting, lack of appetite, metal taste in the mouth, abdominal pain, diarrhea. These adverse reactions most often develop at the beginning of the course, then, as a rule, go away on their own. To reduce the likelihood of these disorders, it is recommended to divide the daily dose into 2-3 doses, take Siofor during or after meals and increase the dose gradually;
  • metabolism: very rarely - lactic acidosis (with the development of this disorder, the drug is canceled); with a long course - a decrease in the absorption of vitamin B12 and its plasma concentration in the blood (should be taken into account in the presence of megaloblastic anemia);
  • liver and biliary tract: isolated cases - liver dysfunctions of a reversible nature, which are expressed as an increase in the activity of hepatic transaminases, hepatitis.

Overdose

With a significant overdose of the drug, there is a risk of developing lactic acidosis, the signs of which are respiratory disorders, nausea, severe weakness, drowsiness, vomiting, abdominal pain, diarrhea, hypothermia, reflex bradyarrhythmia, decreased blood pressure. Confusion and loss of consciousness, muscle pains are also possible.

special instructions

Laboratory tests, standard for patients with diabetes mellitus, should be carried out regularly.

Before using the drug Siofor in children aged 10 to 18 years, the diagnosis of type 2 diabetes should be confirmed.

Since metformin is excreted by the kidneys, the concentration of creatinine in the blood plasma should be determined before starting treatment, and then regularly. Particular care should be taken in cases where there is a risk of impaired renal function, for example, at the beginning of therapy with antihypertensive drugs, diuretics or NSAIDs.

Treatment with Siofor must be temporarily replaced with therapy with other hypoglycemic drugs (for example, insulin) 48 hours before and 48 hours after the X-ray examination with intravenous administration of iodine-containing contrast agents.

The use of Siofor should be discontinued 48 hours before the planned surgery under general anesthesia, with spinal or epidural anesthesia. Continue therapy should be after resumption of oral nutrition or no earlier than 48 hours after surgery, provided that normal renal function is confirmed.

Siofor is not a substitute for diet and daily exercise - these therapies must be combined according to your doctor's recommendations. During treatment with Siofor, all patients should adhere to a diet with an even intake of carbohydrates throughout the day. Overweight patients should follow a low-calorie diet.

In the course of one-year controlled clinical trials, the effect of metformin on the growth and development, as well as on puberty, was not observed in children; there are no data on these indicators with longer use. In this regard, it is recommended to carefully monitor the relevant parameters in children receiving metformin, especially in the prepubertal period (10-12 years).

Monotherapy with Siofor does not lead to hypoglycemia, however, it is recommended to be careful while using the drug with insulin or sulfonylurea derivatives.

Lactic acidosis is a serious pathological condition that is extremely rare, associated with the accumulation of lactic acid in the blood, which can be caused by the accumulation of metformin. The described cases of the development of lactic acidosis in patients receiving metformin were observed mainly in patients with diabetes mellitus with severe renal failure. Prevention of lactic acidosis involves identifying all associated risk factors such as decompensated diabetes, ketosis, prolonged fasting, excessive alcohol consumption, liver failure, and any condition associated with hypoxia. If you suspect the development of lactic acidosis, immediate withdrawal of the drug and emergency hospitalization are recommended.

The use of the drug Siofor does not cause hypoglycemia, therefore it does not affect the ability to drive vehicles and maintain mechanisms.

With the simultaneous use of the drug Siofor with other hypoglycemic drugs (sulfonylurea derivatives, insulin, repaglinide), hypoglycemic conditions may develop, therefore, care must be taken when driving vehicles and other potentially hazardous activities that require concentration of attention and speed of psychomotor reactions.

Interaction with other drugs

Combinations of metformin with other drugs requiring special care due to possible interaction reactions:

  • Angiotensin-converting enzyme (ACE) inhibitors and other antihypertensive drugs - may lower blood glucose levels;
  • Derivatives of sulfonylureas, acarbose, salicylates, insulin - the hypoglycemic effect is enhanced;
  • Diuretics, beta-adrenergic agonists, glucocorticoids (for systemic and local use) - the level of glucose in the blood increases;
  • Indirect anticoagulants - their effect is weakened;
  • Cimetidine - the excretion of metformin slows down, the risk of lactic acidosis is aggravated;
  • Cationic drugs (quinidine, procainamide, morphine, amiloride, vancomycin triamterene, ranitidine) secreted in the tubules - the maximum plasma concentration of metformin increases;
  • Danazol - the development of a hyperglycemic effect is possible (a change in the Siofor dose may be required);
  • Nifedipine - the maximum concentration and absorption of metformin in plasma increases, its excretion is lengthened;
  • Phenothiazine derivatives, epinephrine, thyroid hormones, glucagon, nicotinic acid, oral contraceptives - the concentration of glucose in the blood increases;
  • Furosemide - decreases its concentration and half-life.

Composition

The active ingredient of the drug is metformin hydrochloride.

Each film-coated tablet contains 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).

Other components

Hypromellose, povidone K-25, magnesium stearate (Ph. Eur.), Macrogol 6000, titanium dioxide (E 171).

Description

White oblong, film-coated tablets with a snap-tab on one side and a scoring notch on the other side.

The tablet can be divided into two equal parts

Indications for use

Siofor® 1000 belongs to the group of medicines for the treatment of diabetes (type 2 diabetes mellitus, also known as non-insulin dependent diabetes mellitus).

Siofor® 1000 is a drug for lowering high blood sugar levels in adults and children from 10 years of age with diabetes (type 2 diabetes mellitus).

It is used in particular in overweight patients with insufficient effectiveness of the recommended diet and exercise. The use of Siofor® 1000 helps to reduce the incidence of diabetic organ damage in overweight adults.


For adults, Siofor® 1000 can be used alone or in combination with other drugs that lower blood sugar levels (oral drugs or insulin).

For children from 10 years of age and adolescents, Siofor® 1 OOO can be used alone or in combination with insulin.

Contraindications

In case of allergy (hypersensitivity) to the active substance - metformin hydrochloride - or other components of Siofor® 1000 (see p. 6);

When complications occur against the background of diabetes, namely: with a very strong increase in blood sugar (hyperglycemia) or excessive blood oxidation due to the accumulation of so-called ketone bodies (diabetic ketoacidosis). Signs of these conditions may include abdominal pain, rapid and difficult breathing, drowsiness, or unusual, fruity breath;

With kidney or liver disease;

In acute conditions that can lead to kidney disease, for example:

Loss of fluid due to persistent vomiting or severe diarrhea;

Serious infectious diseases;

If it is necessary to administer an iodine-containing contrast agent for X-ray or other research (see below in the section “Special precautions when using Siofor® 1000”);

For acute or chronic diseases that can lead to oxygen deprivation, for example:

Heart failure;

A recent heart attack;

Circulatory failure (shock);

Lung function disorders;

With acute alcohol intoxication or alcoholism;

When breastfeeding.

The presence of any of the above conditions should be immediately reported to the attending physician.

Pregnancy and lactation

You should consult your doctor or pharmacist before taking any medication.

Pregnancy

If you are pregnant or planning to become pregnant, you should not take Siofor® 1000. In this case, insulin should be used to normalize blood sugar levels. Tell your doctor about your situation to prescribe insulin.

Lactation

During breastfeeding Siofor® 1000 is contraindicated.

Method of administration and dosage

Siofor® 1000 should be taken in strict accordance with the doctor's prescription. If you have any questions, ask your doctor or pharmacist.

The doctor determines the doses of Siofor® 1000 for each patient individually based on the blood sugar level and regularly monitors them. This is especially important when treating children, adolescents and elderly patients.

Each film-coated Siofor® 1000 tablet contains 1000 mg of metformin hydrochloride.

The drug is also available in the form of coated tablets with an active ingredient content of 500 mg and 850 mg.

For the use of Siofor® 1000 separately from other agents;

For combination therapy with other oral medications that lower blood sugar levels (in adults only);

For combined use with insulin.

Adults

(which corresponds to 500 mg of metformin hydrochloride) 2-3 times a day or 850 mg of metformin hydrochloride 2-3 times a day (such a dosage of Siofor 1000 is impossible).

Standard dose after adjustment: 1 coated Siofor® 1000 tablet 2 times a day (which corresponds to 2000 mg of metformin hydrochloride per day).

Maximum dose: 1 coated Siofor® 1000 tablet 3 times a day (which corresponds to 3000 mg of metformin hydrochloride per day).

Standard initial dose: according to the angle of the film-coated Siofor® 1000 tablet,

(which corresponds to 500 mg of metformin hydrochloride) 1 time per day or 850 mg of metformin hydrochloride 1 time per day (such dosage of Siofor® 1000 is impossible).

After 10-15 days, the doctor will adjust the dose depending on the blood sugar level. A gradual increase in the dose improves the tolerability of the drug from the gastrointestinal tract.

Standard dose after adjustment: 1 coated Siofor® 1000 tablet once a day (which corresponds to 1000 mg of metformin hydrochloride per day).

Maximum dose: 1 coated Siofor® 1000 tablet 2 times a day (which corresponds to 2000 mg of metformin hydrochloride per day).

Side effect

Like all medicines, Siofor 1000 can cause side effects, although not everybody gets them.

The following categories are commonly used to estimate the incidence of side effects:

Often:

Very rarely:

Not installed:

Often:

Nausea

Vomit

Stomach ache

Loss of appetite

Such manifestations, as a rule, are observed at the beginning of therapy and in most cases go away spontaneously. To prevent their occurrence, it is recommended to distribute Siofor® 1000 in several doses (2-3) during the day during or after meals. If symptoms persist, seek medical attention.

Taste changes Very rare

Serious metabolic disorders, such as excessive oxidation of the blood by lactic acid (lactic acidosis)

Lactic acidosis is manifested by nausea, vomiting, diarrhea, or abdominal pain. Then, within a few hours, the appearance of muscle pains and spasms, impaired or rapid breathing and clouding of consciousness up to coma are possible. If you suspect lactic acidosis, you should IMMEDIATELY consult a doctor and STOP taking Siofor® 1000!

Decreased blood levels of vitamin B12 due to reduced absorption.

It can be caused by some form of red blood cell deficiency (megaloblastic anemia).

Skin reactions such as redness, itching and rash.

Unusual liver function tests or liver inflammation (hepatitis) with or without jaundice

Both that, and another pass when the drug Siofor® 1000 is canceled.

Children from 10 years of age and adolescents

There is currently insufficient information on the side effects of the drug in children and adolescents. The reported side effects are similar in nature and severity to those seen in adults.

If your side effects get worse, or if you experience any side effects not covered in this leaflet, please tell your doctor or pharmacist.

Overdose

In case of an overdose of Siofor® 1000, you should IMMEDIATELY inform your doctor about it.

An overdose of Siofor® 1000 does not lead to a low blood sugar level (hypoglycemia), but there is a risk of excessive blood oxidation by lactic acid (lactic acidosis). More detailed information on the symptoms that will help to recognize lactic acidosis can be found in section 2 under the heading "Special precautions when using Siofor 1000". In this case, you will need EMERGENCY hospital care.

Interaction with other medicinal products

You should inform the attending physician or pharmacist about the current or recent intake of other drugs, including over-the-counter drugs.

With prolonged use of Siofor® 1000, jumps in blood sugar levels are possible at the beginning and at the end of taking other medications. During this period of time, the blood sugar should be monitored with particular care.

If you are taking or have recently taken any of the following medicines, please tell your doctor or pharmacist about it:

Corticosteroids (such as cortisone);

Certain drugs used for high blood pressure or heart failure (ACE inhibitors)

Diuretics used to lower blood pressure (called diuretics)

Certain medications for the treatment of bronchial asthma (beta-sympathomimetics);

Tell your doctor if you are taking any of the following medications that may have a negative effect on kidney function:

Medicines to lower blood pressure;

Medicines for pain, fever, or rheumatism (NSAIDs).

Application features

It is extremely rare when taking Siofor 1000 there is a risk of excessive blood oxidation by lactic acid (lactic acidosis), in particular in case of serious renal dysfunction. The reason for this may be an undesirable accumulation of the active substance of Siofor® 1000.

Lactic acidosis, if not addressed in time, can be life-threatening consequences (for example, coma).

To reduce the risk of its development, all contraindications (listed above under the heading “ Not take Siofor® 1000 ") and adhere to the prescribed dose.

At first, the symptoms of lactic acidosis may be similar to the side effects of Siofor 1 OOO from the gastrointestinal tract: nausea, vomiting, diarrhea and abdominal pain. Then, within a few hours, the appearance of muscle pains and spasms, impaired or rapid breathing and clouding of consciousness up to coma are possible.

If these symptoms occur, STOP taking Siofor® 1000 and consult a doctor IMMEDIATELY! You may need EMERGENCY hospital care.

The active substance is excreted by the kidneys. Therefore, before starting treatment, as well as at least once a year, and if necessary more often, the doctor should examine the condition of the kidneys.

Particularly careful observation of the work of the organ is necessary

In elderly patients (over the age of 65);

With the simultaneous use of other drugs that can have a negative effect on kidney function. For this reason, you should always tell your doctor about any medications you are taking (see below under the heading “Taking other medications”).

With the introduction of an iodine-containing contrast agent for X-ray or other examination, there is a risk of temporary impairment of renal function. As a result, the excretion of the active substance is impaired, and, as indicated above, the development of lactic acidosis is possible, which, if left untreated, poses a threat to life. Therefore, you should stop taking Siofor® 1000 48 hours (2 days) before the study and resume it only 48 hours (2 days) after the study. But first, your doctor will do an examination to make sure your kidneys are working properly.

If you are scheduled for a planned operation under general anesthesia or with spinal anesthesia, you should also stop taking Siofor® 1000 48 hours (2 days) before. Its use can be continued after the resumption of food intake or no earlier than 48 hours (2 days) after the operation. But first, the doctor must make sure that your kidneys are working properly.

Drinking large amounts of alcohol increases the risk of severely lowering blood sugar levels and developing lactic acidosis. Therefore, during the period of taking Siofor® 1000, alcohol should not be consumed.

The doctor must closely monitor the liver.

Additional precautions

During the period of treatment with Siofor® 1000, you should adhere to the recommended diet and pay special attention to the uniform intake of carbohydrates (starchy foods, such as potatoes, pasta, rice and fruits). If you are overweight, you should continue to follow a low-calorie diet (weight loss diet) under medical supervision.

To control the progress of diabetes, routine blood tests should be done regularly.

Siofor® 1 OOO by itself does not lead to low blood sugar (hypoglycemia). However, concurrent use of other diabetes medications (insulin or sulfonylurea) increases the risk of a sudden drop in blood sugar.

Children from 10 years of age and adolescents

Before using Siofor® 1000 in children and adolescents, the doctor must confirm the diagnosis of diabetes (type 2 diabetes mellitus).

Treatment with Siofor® 1 OOO should be combined with a change in diet and daily exercise.

In the course of one-year controlled clinical studies, the effect of the active substance - metformin hydrochloride - on growth and development, as well as puberty was not observed; the results of longer studies, however, are not yet available. Only a few children aged 10 to 12 participated in clinical trials. When using the drug Siofor 1000 in children of this age group, the doctor should especially carefully observe them during the treatment period.

Elderly patients

Since in elderly patients, kidney function is often impaired, the dose of Siofor 1000 should be adjusted accordingly. For this reason, kidney tests are regularly performed in a medical facility for such patients.