Sandoz metformin – oral hypoglycemic means.

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.

For reduction of complications of diabetes at adult patients with diabetes 2 types and excess body weight as medicament of the first line after an inefficient dietotherapy.

Structure

• active ingredient: metformin;
• 1 tablet contains a hydrochloride of metformin 850 mg;
• other components: povidone, magnesium stearate;
• film covering: gipromelloza, titan dioxide (E 171), macrogoal 4000.

Contraindication

• hypersensitivity to metformin or 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/min.);
• acute conditions which proceed 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 exacerbation of a chronic disease): dekompensirovanny heart failure; respiratory insufficiency; recently postponed myocardial infarction; shock;
• liver failure, acute alcoholic poisoning, alcoholism.

Side reactions

Most often 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 by-effects the slow increase in dosing and use of a daily dose in 2–3 receptions is recommended.

from a metabolism: rare – lactoacidosis. 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: frequent – disturbance of taste.

from a digestive tract: very frequent – nausea, vomiting, diarrhea, a meteorism, lack of appetite, an abdominal pain. Most often these by-effects arise in an initiation of treatment and, as a rule, spontaneously disappear. For prevention of by-effects from a digestive tract the slow increase in a dose and use of medicament 2–3 times a day in time or after a meal is recommended.

Route of administration

or combination therapy together with other oral hypoglycemic means.

Adult. Usually initial dosage makes 500 mg or 850 mg 2–3 times a day in time or after a meal.

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

Slow increase in a dose promotes reduction of 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 to treatment by metformin needs to stop reception of other antidiabetic means.

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 of metformin 2–3 times a day while the dose of insulin should be selected according to results of measurement of level of glucose in blood serum.

therefore the dose of metformin should be selected on the basis of assessment of function of kidneys which needs to be seen off regularly.

Feature of use

Use during pregnancy or feeding by a breast

Pregnancy. Uncontrollable diabetes during pregnancy (gestational or constant) increases risk of developing congenital anomalies and perinatal lethality. There are limited data on metformin use to the pregnant women who are not pointing to the increased risk of congenital anomalies. Feeding by a breast. Metformin is excreted in breast milk, but at the newborns/babies who were on chest feeding, side effects were not observed. As there are not enough data of 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 breastfeeding and potential risk of side effects to the child.

Children

can use Drug for treatment of children for 10 years.

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

Drug does not influence the speed of reactions at control of motor transport or other mechanisms as monotherapy by metformin does not lead to a hypoglycemia.

Trace with care to apply metformin in a combination with other hypoglycemic means (sulphonylurea derivatives, insulin, repaglinid, 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. In case of development of lactoacidosis the medicament treatment should be stopped and to urgently hospitalize the patient. 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 required by

to p.

to Store

out of children's reach.