Product description

Metformin Sandoz is an oral hypoglycemic agent.

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.
• To reduce complications of diabetes in adult patients with type 2 diabetes and excess body weight, as a first-line preparation after ineffective diet therapy

Storage

active substance: metformin;

1 tablet contains metformin hydrochloride 500 mg;

excipients: povidone, magnesium stearate;

film coating: hypromellose, titanium dioxide (E 171), macrogol 4000.

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 (glomerular filtration rate (GFR) < 30 ml/min);
• acute conditions with a risk of developing kidney dysfunction, such as:
• body 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 poisoning, alcoholism.

Adverse reactions

The most frequent adverse reactions at the beginning of treatment are nausea, vomiting, diarrhea, abdominal pain, lack of appetite. In most cases, these symptoms go away on their own. To prevent the occurrence of these side effects, it is recommended to slowly increase the dosage and use the daily dose of the preparation in 2-3 doses.

From the side of metabolism: rare - 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: frequent - taste disturbances.

From the side of the digestive tract: very frequent - nausea, vomiting, diarrhea, flatulence, lack of appetite, abdominal pain. Most often, these side effects occur at the beginning of treatment and, as a rule, disappear spontaneously. To prevent side effects from the digestive tract, it is recommended to slowly increase the dose and use the preparation 2-3 times a day during or after meals.

Application method.

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

Adults Usually, the starting dose is 500 mg or 850 mg 2-3 times a day during or after meals.

After 10–15 days of the treatment, 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.

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

In the case of switching from another antidiabetic agent to treatment with metformin, it is necessary to stop taking the other antidiabetic agent.

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

Renal function may decrease in elderly patients, so the dose of metformin should be selected based on the assessment of renal function, which should be carried out regularly.

Features of application

Use during pregnancy or breastfeeding

Pregnancy. Uncontrolled diabetes during pregnancy (gestational or permanent) increases the risk of congenital anomalies and perinatal mortality. There are limited data on the use of metformin in pregnant women, which do not indicate an increased risk of congenital anomalies. Breast-feeding. Metformin is excreted in breast milk, but in newborns/infants who were breastfed, side effects were not observed. Since there is insufficient data on the safety of the preparation, breastfeeding is not recommended during metformin therapy. 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

The preparation can be used to treat children over 10 years old.

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

The preparation does not affect the speed of reactions when driving a motor vehicle or other mechanisms, since metformin monotherapy does not cause hypoglycemia.

Metformin should be used with caution in combination with other hypoglycemic agents (sulfonylureas, insulin, repaglinide, 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 can cause lactic acidosis. If lactic acidosis develops, treatment with the preparation must be stopped and the patient must be hospitalized immediately. Hemodialysis is the most effective way to remove lactate and metformin from the body.

Storage conditions

No special storage conditions are required.

Keep out of the reach of children.