Metformin-Tev of the tab. of p/o of 500 mg No. 50

Metformin-Tev – oral hypoglycemic means, except for insulin, indications

Diabetes 2 types at inefficiency of a dietotherapy and mode of physical activities, especially at patients with excess body weight;

• as monotherapy or combination therapy together with other oral hypoglycemic means or together with insulin for treatment of adults;
• as monotherapy or combination therapy with insulin for treatment of children for 10 years and teenagers.

Reduction of complications of diabetes at adult patients with diabetes 2 types and excess body weight applied by metformin as medicament of the first line after an inefficient dietotherapy.

Structure

• active ingredient: metformin hydrochloride;
• 1 tablet contains a hydrochloride of metformin 500 mg;
• other components: kernel: K-30 povidone, silicon dioxide colloidal anhydrous, magnesium stearate; film covering *: gipromelloza (2910/5), titan dioxide (E 171), macrogoal (type 400).

Contraindication

Hypersensitivity to metformin or any other component of drug.

Any type of an acute metabolic acidosis (for example, lactacidemia, diabetic ketoacidosis).

Diabetic prekoma.

Heavy renal failure (SKF <30 ml/min.).

Acute conditions proceeding with risk of developing renal failures: organism dehydration; serious infectious diseases; shock.

Disease which can cause development of a fabric hypoxia (especially acute diseases or exacerbation of a chronic disease): dekompensirovanny heart failure, respiratory insufficiency, recently postponed myocardial infarction, shock.

Liver failure.

Acute drunkenness, alcoholism.

Side reactions

Most often undesirable reactions, especially in an initiation of treatment, are nausea, vomiting, diarrhea, an abdominal pain, lack of appetite.

from digestive tract the nausea, vomiting, lack of appetite, diarrhea, an abdominal pain can be observed. More often these by-effects arise in an initiation of treatment and, as a rule, pass independently. For prevention of side reactions from digestive tract the slow increase in a dosage and use of a daily dose of medicament in 2-3 inclusion in time or after a meal is recommended.

from metabolism: lactacidemia. At prolonged use of medicament B12 vitamin absorption can decrease that is followed by decrease in its level in blood serum. It is recommended to consider such possible cause of hypovitaminosis of B12 if the patient has a megaloblastny anemia.

from nervous system: disturbance of taste.

from a gepatobiliarny system: in isolated cases – decrease in the indicators of function of a liver or hepatitis completely disappearing after metformin cancellation.

from skin and hypodermic cellulose: skin reactions, including an erythema, an itching, a small tortoiseshell.

Route of administration

or combination therapy together with other oral hypoglycemic means.

Usually initial dose makes 500 mg or 850 mg (to apply in the corresponding dosage) a metformin hydrochloride 2-3 times a day in time or after a meal.

In 10-15 days a dose needs to be modified according to results of measurements of level of glucose in blood serum.

Slow increase in a dose promotes decrease in side effects from a digestive tract.

.

Maximum recommended dose makes 3000 mg/days, distributed on 3 receptions.

in case of transition from other antidiabetic means needs to stop reception of this means and to appoint metformin as it is stated above.

Combination therapy together with insulin.

in blood metformin and insulin can be applied To achievement of the best control of glucose in the form of combination therapy. Usually initial dose makes 500 mg or 850 mg (to apply in the corresponding dosage) a metformin hydrochloride 2-3 times a day while the dose of insulin should be selected according to results of measurement of level of glucose in blood.

Feature of use

Use during pregnancy or feeding by a breast

Pregnancy. In case of pregnancy planning and also at approach of pregnancy for treatment of diabetes it is recommended to apply not metformin, but insulin to maintenance of level of glucose of blood as close as possible to normal for reduction of risk of development of defects of a fruit.

Feeding by a breast. Metformin gets into breast milk, but at the newborns/babies who were on chest feeding, side effects were not observed. However, as there are not enough data on safety of use of metformin when feeding by a breast, its use is not recommended during this period. The decision on the feeding termination by a breast needs to be made taking into account advantages of breastfeeding and potential risk of side effects to the child.

Metformin to apply

to treatment of children for 10 years.

Ability to influence speed of response at control of motor transport or other mechanisms

metformin does not influence speed of response at control of motor transport or work with other mechanisms as medicament does not cause a hypoglycemia. However it is necessary to be careful at use of metformin in combination with other hypoglycemic means (sulphonylurea derivatives, insulin or meglitinida) because of risk of development of a hypoglycemia.

Overdose

At use of medicament in a dose of 85 g of development of a hypoglycemia it was not observed. However in this case development of a lactacidemia was observed. Considerable exceeding a dose of metformin or contributing factors of risk can cause a lactacidemia. The lactacidemia is medical emergency and it is necessary to treat in a hospital. The most effective measure for removal from an organism of a lactate and metformin is the hemodialysis.

Storage conditions

Special storage conditions it is not provided by p. To store out of children's reach.