Product description

Metformin-Teva - an oral hypoglycemic agent, excluding insulin, indications for use

• Type 2 diabetes in case of ineffectiveness of diet therapy and physical activity regime, especially in patients with excess body weight;
• as monotherapy or combined therapy in combination with other oral hypoglycemic agents or in combination with insulin for the treatment of adults;
• as monotherapy or in combination with insulin for the treatment of children aged 10 years and older and adolescents.
• Reduction of diabetic complications in adult patients with type 2 diabetes mellitus and overweight who used metformin as a first-line preparation after ineffective diet therapy.

Storage

active substance: metformin hydrochloride;

1 tablet contains metformin hydrochloride 850 mg;

auxiliary substances: core: povidone K-30, colloidal anhydrous silicon dioxide, magnesium stearate; film coating*: hypromellose (2910/5), titanium dioxide (E 171), macrogol (type 400).

Contraindication

Hypersensitivity to metformin or any other component of the preparation.

Any type of acute metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis).

Diabetic precoma.

Severe renal failure (GFR < 30 ml/min).

Acute conditions that occur with the risk of developing kidney dysfunction: dehydration; severe infectious diseases; shock.

Diseases that can lead to the development of tissue hypoxia (especially acute diseases or exacerbation of chronic diseases): decompensated heart failure, respiratory failure, recent myocardial infarction, shock.

Liver failure.

Acute alcohol intoxication, alcoholism.

Adverse reactions

The most frequent adverse reactions, especially at the beginning of treatment, are nausea, vomiting, diarrhea, abdominal pain, lack of appetite.

From the gastrointestinal tract: nausea, vomiting, lack of appetite, diarrhea, abdominal pain may occur. Most often, these side effects occur at the beginning of treatment and, as a rule, pass on their own. To prevent adverse reactions from the gastrointestinal tract, it is recommended to slowly increase the dosage and use the daily dose of the preparation in 2-3 doses during or after eating.

From the side of metabolism: lactic acidosis. With long-term use of the preparation, the absorption of vitamin B12 may decrease, which is accompanied by a decrease in its level in blood serum. It is recommended to consider this possible cause of hypovitaminosis B12 if the patient has megaloblastic anemia.

From the side of the nervous system: taste disturbances.

From the side of the hepatobiliary system: in isolated cases - a decrease in liver function indicators or hepatitis, which completely disappear after withdrawal of metformin.

From the side of the skin and subcutaneous tissue: skin reactions, including erythema, itching, urticaria.

Application method

Monotherapy or combined therapy is compatible with other oral hypoglycemic agents.

Usually, the initial dose is 500 mg or 850 mg (to be used in the appropriate dosage) of metformin hydrochloride 2-3 times a day during or after eating.

After 10-15 days, the dose must be adjusted according to the results of measuring the level of glucose in the blood serum.

A slow increase in the dose helps to reduce side effects from the digestive tract.

When treating with high doses (2000-3000 mg/day), it is possible to replace every 2 tablets of Dianormet® 500 mg or Metformin-Teva 500 mg with 1 tablet of Metformin-Teva 1000 mg.

The maximum recommended dose is 3000 mg/day, divided into 3 doses.

In the case of switching from another antidiabetic agent, it is necessary to stop taking this agent and prescribe metformin as indicated above.

Combined therapy is compatible with insulin.

Metformin and insulin can be used in combination therapy to achieve better blood glucose control. Usually, the starting dose is 500 mg or 850 mg (to be used in the appropriate dosage) of metformin hydrochloride 2-3 times a day, while the dose of insulin should be selected according to the results of measuring the level of glucose in the blood.

Features of application

Use during pregnancy or breastfeeding

Pregnancy. In the case of pregnancy planning, as well as in the event of pregnancy, it is recommended to use insulin instead of metformin for the treatment of diabetes to maintain blood glucose levels as close to normal as possible in order to reduce the risk of developing fetal defects.

Breast-feeding. Metformin passes into breast milk, but in newborns/infants who were breastfed, no side effects were observed. However, since there are insufficient data on the safety of metformin use during breastfeeding, its use is not recommended during this period. The decision to stop breastfeeding must be made taking into account the benefits of breastfeeding and the potential risk of side effects for the baby.

Children

Metformin should be used to treat children over 10 years of age.

The ability to influence the speed of reaction when driving vehicles or other mechanisms

Metformin monotherapy does not affect the speed of reaction when driving a vehicle or working with other mechanisms, as the preparation does not cause hypoglycemia. However, caution should be exercised when using metformin in combination with other hypoglycemic agents (sulfonylureas, insulin, or meglitinides) due to the risk of hypoglycemia.

Overdose

When using the preparation in a dose of 85 g, the development of hypoglycemia was not observed. However, in this case, the development of lactic acidosis was observed. A significant overdose of metformin or associated risk factors may cause lactic acidosis. Lactic acidosis is an emergency and should be treated in a hospital. Hemodialysis is the most effective way to remove lactate and metformin from the body.

Storage conditions

There are no special storage conditions. Keep out of the reach of children.