Glucophage® (Metformin) 850 mg (60 coated tablets)

Structure

One tablet contains 850 mg metformin hydrochloride
Film-coated tablets. 20 tablets in a blister strip packaging. 3 blister packs, together with instructions for medical use, are placed in a cardboard box.

Indications

- diabetes mellitus non-insulin dependent in adults with ineffective diet therapy (especially in obese patients)
- diabetes mellitus, accompanied by secondary insulin resistance, especially in severe obesity, in combination with insulin
- diabetes mellitus in children from 10 years of age - both with monotherapy and in combination with insulin

Contraindications

- hypersensitivity to metformin hydrochloride or to any excipient
- diabetic ketoacidosis, diabetic precomatose state, coma
- renal failure or impaired renal function (creatinine clearance less than 60 ml / min in urine)
- dehydration, severe infection, hypoglycemic shock, intravenous administration of iodinated contrast agents, which can lead to impaired renal function
- cardiac or respiratory disorders with tissue hypoxia
- recent myocardial infarction
- alcoholism and acute alcohol intoxication
- anemia
- liver failure
- pregnancy, lactation period
- application for at least 2 days before and within 2 days after carrying out radioisotope or X-ray studies with the introduction of an iodine-containing contrast agent

Mode of application

Adults: Monotherapy and combination therapy in combination with other oral antidiabetic agents:
The usual starting dose is one tablet 2-3 times daily after or during a meal.
After 10-15 days of treatment, the dose must be adjusted based on the results of blood glucose measurements. Slowly increasing the dose may help to improve gastrointestinal tolerance.
For patients who are prescribed high doses of the drug (2000-3000 mg per day), it is recommended to take Glucophage with a dosage of 1000 mg. The maximum recommended dose is 3000 mg per day (1 tablet of Glucophage 1000 mg in three divided doses).
If you are planning to switch from taking another antidiabetic drug: you must stop taking the other drug and start taking Glucophage at the dose indicated above.
Combination with insulin:
To achieve better blood glucose control, Glucophage and insulin can be used in combination therapy. The usual initial dose of Glucophage 500 mg or 850 mg is one tablet 2-3 times a day, Glucophage 1000 mg -1 tablet once a day, while the dose of insulin is selected based on the results of blood glucose measurements.
Children and adolescents:
In children from 10 years of age, Glucophage can be used both as monotherapy and in combination with insulin. The usual starting dose is 500 mg 2–3 times daily after or during a meal. After 10-15 days of treatment, the dose must be adjusted based on the results of blood glucose measurements. Slowly increasing the dose may improve gastrointestinal tolerance. The maximum recommended dose is 2000 mg of Glucophage per day, divided into 2-3 doses.
Elderly patients: due to a possible decrease in renal function in elderly people, the dose of Glucophage must be selected based on renal function (measurement of creatinine levels in the blood!).

Side effects

Very often
- loss of appetite, nausea, vomiting, abdominal pain and diarrhea
Often
- taste disturbance
Very rarely
- skin reactions (itching, erythema, rash)
- lactic acidosis
- hepato-biliary disorders (transient increases in transaminases)

During pregnancy

When planning pregnancy, as well as in case of pregnancy while taking Glucophage, the drug should be canceled, and insulin therapy should be prescribed. You must inform your doctor about the onset of pregnancy while taking Glucophage.

The mother and the newborn are monitored. Since there is no data on penetration into breast milk, this drug is contraindicated for breastfeeding. If necessary, the use of Glucophage during breastfeeding, breastfeeding should be discontinued.

Special instructions

If during treatment the patient develops vomiting, abdominal pain, muscle pain, general weakness and severe malaise, it is necessary to stop taking the drug and immediately consult a doctor. These symptoms can be a sign of incipient lactic acidosis.

48 hours before and within 48 hours after the X-ray contrast study (urography, intravenous angiography) with the introduction of an iodine-containing contrast agent, you should stop taking Glucophage.

It is necessary to stop taking Glucophage 48 hours before the surgery with general, spinal and epidural anesthesia; the drug should not be resumed within 48 hours after the surgery until renal function is restored.

Since metformin is excreted by the kidneys, serum creatinine levels should be measured before starting treatment and regularly thereafter.

Particular care should be taken in cases where renal function may be impaired, for example, during the initial period of antihypertensive therapy or diuretic therapy, and during initial therapy with non-steroidal anti-inflammatory drugs.

If a patient develops a bronchopulmonary infection or an infectious disease of the genitourinary organs, it is necessary to inform the doctor.

GI disorders most often occur during the initial period of treatment and in most cases resolve spontaneously. To prevent symptoms, it is recommended to take Glucophage 2 or 3 times a day during or after meals. Slowly increasing the dose may improve gastrointestinal tolerance.

With prolonged treatment with Glucophage, the absorption of vitamin B12 may decrease. This must be taken into account when prescribing to patients with megaloblastic anemia.
After discontinuation of the drug, in isolated cases, violations of liver function indicators were observed.

During treatment, you must refrain from drinking alcohol!

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms
Monotherapy with Glucophage does not cause hypoglycemia and therefore does not affect the ability to drive and operate machinery. However, patients should be wary of the risk of hypoglycemia when using Glucophage in combination with other antidiabetic drugs (sulfonylurea derivatives, insulin, repaglinide).

Overdose

When using Glucophage at a dose of 85 g, the development of hypoglycemia was not observed. However, in this case, the development of lactic acidosis was observed.
Early symptoms of lactic acidosis: nausea, vomiting, diarrhea, fever, abdominal pain, muscle pain, in the future there may be increased breathing rate, dizziness, impaired consciousness and the development of coma.
Treatment: In case of signs of lactic acidosis, treatment with Glucophage should be stopped immediately, the patient should be urgently hospitalized and, having determined the concentration of lactate, the diagnosis should be clarified.

The most effective measure for removing lactate and Glucophage from the body is hemodialysis. Symptomatic treatment is also carried out.

Shelf life 5 years