Siofor 850 film-coated tablets 850 mg No. 60

What is Siofor?

Siofor is an oral hypoglycemic (lowering blood glucose concentration) drug intended for the treatment of type II diabetes mellitus (non-insulin-dependent) by controlling blood sugar levels.

It is used in complex treatment along with diet, as well as special exercises for people with type 2 diabetes and obesity.

The active ingredient of this medication is metformin. Its pharmacological effect works by inhibiting the production of glucose (gluconeogenesis) in the liver. It reduces the absorption of glucose in the intestine. It also dulls the feeling of hunger and promotes weight loss.

Siofor is sometimes used with insulin or other medications, but not to treat type 1 diabetes.

What you need to know before you start taking Siofor

First of all, you should not take this medicine if you have an individual intolerance to the active and auxiliary substances of the drug Siofor.

Siofor should not be taken if you have:

• severe kidney disease;
• metabolic acidosis (high blood acid or acid-base imbalance) - this can increase the risk of infections and heart problems, and can also worsen kidney problems.

If you need to have an X-ray or any type of computed tomography (CT) scan that uses dye injected into veins, you may need to temporarily stop taking Siofor 2 days before and after such procedures.

If while taking Siofor you have any severe infection, chronic alcoholism, or if you are 65 years of age or older, then there is a risk of lactic acidosis - this is a dangerous accumulation of lactic acid in the blood.

With long-term use of Siofor, there is a deterioration in the absorption of vitamin B12 (cyanocobalamin), this is especially important for people suffering from anemia.

Controlling diabetes is important during pregnancy, and high blood sugar can cause complications for both mother and baby.

Siofor may stimulate ovulation in premenopausal women (the initial period of decreased ovarian function) and may increase the risk of unintended pregnancy.

Contraindications to the use of the drug Siofor

If you have a history of one or more of the following health conditions, Siofor suitable

• kidney disease;
• liver diseases;
• heart problems such as congestive heart failure;
• ketonuria (increased levels of ketones in urine);
• ketoacidosis (high levels of ketones in the blood).

You should not take Siofor if you are pregnant or if you are breastfeeding.

Siofor is prohibited for use in children under 10 years of age. At the age of 10 to 12 years, the drug should be taken with caution under the strict guidance of a doctor.

Contraindications

Hypersensitivity, diabetes mellitus type 1 (insulin-dependent), complete cessation of endogenous insulin secretion in diabetes mellitus type 2, diabetic ketoacidosis, diabetic precoma, coma, liver and kidney dysfunction, cardiac and respiratory failure, acute phase of myocardial infarction, severe infectious diseases, surgery , injuries, conditions with enhanced decay processes (for example, in tumor diseases), hypoxic conditions, chronic alcoholism, lactic acidosis (including a history), following a calorie-restricted diet (less than 1000 kcal/day), childhood.

Directions for use and dosage of Siofor

Siofor is available in dosages of 0.5 g (500 mg), 0.85 g (850 mg) and 1 g (1000 mg).

Usual Adult Dose for Type 2 Diabetes:

Initial dose: 500 mg orally 2 times a day or 850 mg orally 1 time a day, or half a tablet (1/2) at a dosage of 1000 mg, divided into two doses per day.

If necessary, increase the dose, but always gradually - this will help avoid side effects from the gastrointestinal tract.

Depending on the level of glycemia (blood glucose) as prescribed by the doctor, the dose may be:

• at a dose of 0.5 g - 3-4 tablets per day;
• at a dose of 0.85 g - 2-3 tablets. in a day;
• at a dose of 1 g - up to 2 tablets per day.

The maximum daily dose should not exceed 3 g per day, divided into three doses per day.

At the age of 12 to 18 years, the maximum daily dose of Siofor should not exceed 2 g per day, divided into 2-3 doses.

For complex treatment of type 1 diabetes mellitus:

To improve blood sugar control, Siofor can be combined with insulin. In this case, the dosage and use regimen is the same as in the treatment of non-insulin-dependent diabetes (type 2).

Composition and release form

Siofor® 500

10 pcs in blister; There are 3, 6 or 12 blisters in a box.

Siofor® 850

15 pcs in blister; There are 2, 4 or 8 blisters in a box.

What should you not do while taking Siofor?

Excessive alcohol consumption should while taking Siofora, since alcohol-containing drinks increase the decrease in blood sugar, as a result of which the risk of developing lactic acidosis (a complication of diabetes mellitus, accompanied by the accumulation of lactate in the blood due to lack of insulin) may increase.

It is worth remembering that although Siofor is used in complex treatment for type 1 diabetes, it is strictly not recommended to take it independently as an auxiliary therapy without a doctor’s prescription.

Interaction

Sulfonylurea derivatives, insulin, some NSAIDs (aspirin), oxytetracycline antibiotics, beta-blockers, MAO inhibitors, ACE inhibitors enhance the hypoglycemic effect. Glucocorticoids; drugs containing female sex hormones (contraceptives); thyroid hormones; some sedatives and hypnotics (phenothiazine derivatives); diuretics, nicotinic acid derivatives weaken the hypoglycemic effect.

Taking cimetidine may increase the risk of developing lactic acidosis.

Drinking alcohol during treatment with the drug increases the risk of developing severe side effects (hypoglycemia, lactic acidosis).

What are the side effects of Siofor?

Common side effects of Siofor may include:

• hypoglycemia (low blood sugar);
• disturbance of taste sensations;
• digestive disorders (nausea, vomiting, metallic taste, diarrhea).

Some people taking this medication are at risk of developing lactic acidosis, which can be fatal. contact an ambulance as soon as possible if you have one or more symptoms of this condition:

• unusual muscle pain;
• feeling cold;
• labored breathing;
• dizziness;
• feeling very tired;
• sharp pain in the abdomen;
• vomit;
• slow or irregular heartbeat.

Siofor® 850 (Siofor® 850)

Lactic acidosis

Lactic acidosis is a rare but serious (high mortality unless promptly treated) complication that may occur due to accumulation of metformin. Cases of lactic acidosis when taking metformin occurred mainly in diabetic patients with severe renal failure.

Other associated risk factors should be taken into account, such as decompensated diabetes mellitus, ketosis, prolonged fasting, alcoholism, severe infectious disease, liver failure and any condition associated with severe hypoxia, and concomitant use of drugs that can cause the development of lactic acidosis (see section "Interaction with other drugs"). This may help reduce the incidence of lactic acidosis. The risk of developing lactic acidosis should be taken into account when nonspecific signs appear, such as muscle cramps accompanied by dyspeptic disorders, abdominal pain and severe asthenia.

Lactic acidosis is characterized by acidotic shortness of breath, abdominal pain and hypothermia followed by coma. Diagnostic laboratory parameters are a decrease in blood pH (less than 7.35), lactate content in the blood plasma over 5 mmol/l, an increased anion gap and the lactate/pyruvate ratio. If metabolic acidosis is suspected, stop taking the drug and consult a doctor immediately.

Surgical operations

Metformin should be discontinued during surgery under general, spinal or epidural anesthesia. Metformin therapy can be continued no earlier than 48 hours after surgery or resumption of food intake, provided that the examination has not revealed a deterioration in renal function.

Kidney function

Since metformin is excreted by the kidneys, it is necessary to determine CC before starting treatment and regularly thereafter:

• at least once a year in patients with normal renal function;
• every 3-6 months in patients with CC 45-59 ml/min;
• every 3 months in patients with CC 30-44 ml/min.

In the case of CC less than 30 ml/min, the use of the drug is contraindicated.

Particular caution should be exercised in case of possible impaired renal function in elderly patients, with dehydration (chronic or severe diarrhea, repeated bouts of vomiting), and with the simultaneous use of antihypertensive drugs, diuretics or non-steroidal anti-inflammatory drugs.

Heart failure

Patients with heart failure have a higher risk of developing hypoxia and renal failure. Patients with chronic heart failure should have cardiac and renal function monitored regularly while taking metformin. Taking metformin in acute heart failure with unstable hemodynamic parameters is contraindicated.

Children and teenagers

The diagnosis of type 2 diabetes mellitus must be confirmed before starting treatment with metformin.

In clinical studies lasting 1 year, metformin was shown to have no effect on growth and puberty. However, due to the lack of long-term data, careful monitoring of the subsequent effects of metformin on these parameters in children, especially during puberty, is recommended. The most careful monitoring is necessary for children aged 10-12 years.

The use of iodine-containing radiocontrast agents

Intravascular administration of iodinated contrast agents can lead to the development of renal failure and accumulation of metformin, which increases the risk of developing lactic acidosis. Metformin should be discontinued 48 hours before an X-ray examination using iodinated radiocontrast agents, and not resumed until 48 hours after it, provided that the examination did not reveal a deterioration in renal function.

Other Precautions

- Patients are advised to continue to follow a diet with even carbohydrate intake throughout the day. Overweight patients are recommended to continue to follow a hypocaloric diet (but not less than 1000 kcal/day).

— It is recommended that routine laboratory tests be performed regularly to monitor diabetes mellitus.

— Metformin in monotherapy does not cause hypoglycemia, however, it is recommended to exercise caution when using it in combination with insulin or other hypoglycemic agents (for example, sulfonylurea derivatives, repaglinide, etc.).

The use of metformin is recommended for the prevention of type 2 diabetes mellitus in persons with prediabetes and additional risk factors for the development of overt type 2 diabetes mellitus, such as: age less than 60 years, body mass index (BMI) ≥ 30 kg/m2, history of gestational diabetes mellitus, family history history of diabetes mellitus in first-degree relatives, increased triglyceride concentrations, decreased HDL cholesterol concentrations, arterial hypertension.

— Metformin did not affect the fertility of male and female rats when administered at doses three times the maximum recommended daily dose for humans.

Symptoms and consequences of an overdose of Siofor

an overdose of this drug may occur These conditions are accompanied by symptoms such as:

• gastrointestinal problems (severe abdominal pain, nausea, vomiting, diarrhea);
• confusion, severe weakness;
• decrease in body temperature;
• bradycardia (decreased heart rate);
• decrease in blood pressure.

If you notice at least one of the symptoms presented above, you need to immediately go to an ambulance followed by hospitalization for timely medical care, which involves hemodialysis (blood purification) to remove excess lactic acid from the body.

Interaction of Siofor with other drugs and substances

Many medications can interact with Siofor, making it less effective or increasing the risk of lactic acidosis.

List of drugs that may interact with Siofor:

• X-ray contrast agents - increase the cumulation (accumulation) of Siofor and increase the risk of lactic acidosis;
• danazol (synthetic male hormone - androgen) - can lead to hyperglycemia (high blood sugar);
• nifedipine (a drug that lowers blood pressure), cimetidine (anti-ulcer) - slow down the elimination of Siofor from the body;
• other hypoglycemic agents - the effect of hypoglycemia is enhanced;
• indirect anticoagulants - Siofor weakens their effect;
• furosemide (diuretic) - Siofor reduces its concentration in the blood plasma.

Note!

The combined use of Siofor and alcohol increases the risk of developing a complication of diabetes, called lactic acidosis. This condition can be fatal.

This list of joint interactions with Siofor is not complete; for more detailed information, you should consult a medical specialist.