Tablets " ^{Metaminum ®} " are shown to use:

• in diabetes of the 2nd type 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 aged from 10 years and teenagers);
• for reduction of complications of diabetes at adult patients with diabetes of the 2nd type and excess body weight, as medicament of the first line after an inefficient dietotherapy.

Structure

One tablet contains metformin of a hydrochloride 850 mg.

Excipients: lactose, povidone, magnesium stearate, silicon dioxide colloidal, hydroksipropilmetiltsellyuloza.

Contraindication

• hypersensitivity to metformin or to any other component of drug;
• any type of an acute metabolic acidosis (for example lactoacidosis, diabetic ketoacidosis);
• diabetic prekoma;
• renal failure of heavy degree (glomerular filtration rate (GFR) <30 ml/minute);
• acute conditions proceeding with risk of developing renal failures such, as: organism dehydration, serious infectious diseases, shock;
• a disease which can lead to development of a hypoxia of fabrics (especially acute diseases or exacerbations of a chronic disease): dekompensirovanny heart failure, respiratory insufficiency, recently postponed myocardial infarction, shock;
• liver failure, acute alcoholic poisoning, alcoholism.

Route of administration

Adult (with normal function of kidneys - SKF ≥ 90 ml/minute)

or combination therapy together with other oral hypoglycemic means: usually, the initial dose makes 500 mg or 850 mg 2-3 times a day in time or after meal; in 10-15 days the 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; the maximum recommended dose makes 3000 mg a day in 3 receptions (in case of transition from other antidiabetic means it is necessary to stop reception of this means and to appoint metformin as it is stated above).

Combination therapy in combination with insulin: in blood metformin and insulin can be applied to achievement of the best control of glucose level in the form of combination therapy, usually initial dose makes 500 mg or 850 mg of metformin of a hydrochloride 2-3 times a day whereas the dose of insulin has to be selected according to results of measurement of level of glucose in blood.

Children

or combination therapy together with insulin: medicament is appointed to children aged from 10 years and to teenagers, usually initial dose makes 500 mg or 850 mg of metformin of 1 times a day in time or after meal; in 10-15 days the 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; the maximum recommended dose makes 2000 mg a day in 2-3 receptions.

Feature of use

Pregnant

Uncontrollable diabetes during pregnancy (gestational or constant) increases risk of developing congenital anomalies and perinatal lethality. The available limited these uses of metformin to pregnant women do not indicate the increased risk of congenital anomalies. Preclinical trials did not reveal negative impact on pregnancy, development of an embryo or a fruit, childbirth and postnatal development. In case of pregnancy planning and also in case of 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 to reduce risk of development of defects of a fruit.

in breast milk, but at the newborns/babies who were on breastfeeding, side effects was not observed. However, as there are not enough data on safety of use of drug, feeding by a breast is not recommended during therapy by metformin. The decision on the feeding termination by a breast needs to be made taking into account advantages of feeding by a breast and potential risk of side effects for the child.

Drivers

metformin does not influence speed of response at control of motor transport or other mechanisms as medicament does not cause a hypoglycemia. However it is necessary to be careful at use of metformin in a 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 lactoacidosis was observed. Considerable exceeding a dose of metformin or contributing factors of risk can cause lactoacidosis. Lactoacidosis is medical emergency, demands treatment in a hospital. The most effective action for removal from an organism of a lactate and metformin is the hemodialysis.

Side effects

Frequent undesirable reactions in an initiation of treatment are nausea, vomiting, diarrhea, an abdominal pain, lack of appetite. These symptoms in most cases pass independently. For prevention of emergence of the specified by-effects the slow increase in a dosage and use of a daily dose in 2-3 receptions is recommended.

to Store

in original packing at a temperature not above 25 °C, out of children's reach.

Expiration date - 3 years.