Merifatin, 500 mg 60 pcs

Type 2 diabetes

Type 2 diabetes mellitus, especially in patients with obesity, with ineffectiveness of diet therapy and physical activity:

– in adults as monotherapy or in combination with other oral hypoglycemic agents or with insulin;

– in children from 10 years of age as monotherapy or in combination with insulin.

The prevention of type 2 diabetes mellitus in pre-diabetic patients with additional risk factors for type 2 diabetes in whom lifestyle changes have failed to achieve adequate glycemic control.

Indications

Type 2 diabetes mellitus, especially in obese patients, with ineffective diet therapy and exercise:

• in adults as monotherapy or in combination with other oral hypoglycemic agents or insulin;

• in children over 10 years of age as monotherapy or in combination with insulin.

Prevention of type 2 diabetes mellitus in patients with prediabetes with additional risk factors for developing type 2 diabetes mellitus in whom lifestyle changes have not allowed them to achieve adequate glycemic control.

Special instructions

Duration of treatment

Metformin should be taken daily, without interruption. If treatment is stopped, the patient must inform the doctor.

Active ingredient

Metformin

Composition

1 tablet contains:

Active ingredient:

metformin hydrochloride 500 mg.

Excipients:

hypromellose 2208 5.0 mg;

povidone K90 (kollidon 90F) 20.0 mg;

sodium stearyl fumarate 5.0 mg.

Film water-soluble coating:

hypromellose 2910 7.0 mg; polyethylene glycol 6000 (macrogol 6000) 0.9 mg; polysorbate 80 (Tween 80) 0.1 mg; titanium dioxide 2.0 mg.

Contraindications

• Hypersensitivity to metformin or to any excipient;

• diabetic ketoacidosis, diabetic precoma, coma;

• renal failure or impaired renal function (creatinine clearance less than 45 ml/min);

• acute conditions with a risk of developing renal dysfunction: dehydration (with diarrhea, vomiting), severe infectious diseases, shock;

• clinically pronounced manifestations of acute or chronic diseases that can lead to the development of tissue hypoxia (including 4 acute heart failure, chronic heart failure with unstable hemodynamic parameters, respiratory failure, acute myocardial infarction);

• extensive surgical operations and injuries, when insulin therapy is indicated (see section “Special Instructions”);

• liver failure, liver dysfunction;

• chronic alcoholism, acute alcohol poisoning;

• pregnancy;

• lactic acidosis (including history);

• use for less than 48 hours before and within 48 hours after radioisotope or x-ray studies with the introduction of an iodine-containing contrast agent (see section “Interaction with other drugs”);

• adherence to a hypocaloric diet (less than 1000 kcal/day).

Side Effects

The frequency of side effects of the drug is assessed as follows: very often (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000).

Side effects are presented in order of decreasing importance.

Metabolism and nutrition: very rarely – lactic acidosis (see “Special Instructions”). With long-term use of metformin, a decrease in the absorption of vitamin B12 may be observed. When megaloblastic anemia is detected, the possibility of such an etiology must be taken into account.

From the nervous system: often – taste disturbance.

From the gastrointestinal tract: very often – nausea, vomiting, diarrhea, abdominal pain, lack of appetite. Most often they occur during the initial period of treatment and in most cases resolve spontaneously. To prevent symptoms, it is recommended to take metformin 2 or 3 times a day with or after meals. Slowly increasing the dose may improve gastrointestinal tolerability.

From the skin and subcutaneous tissue: very rarely – skin reactions such as erythema, itching, rash.

Disorders of the liver and biliary tract: very rarely – abnormal liver function tests or hepatitis; after discontinuation of metformin, these adverse effects completely disappear.

Published data, post-marketing data, and controlled clinical studies in limited pediatric populations aged 10-16 years indicate that side effects are similar in nature and severity to those observed in adult patients.

Clinical pharmacology

Hypoglycemic agent of the biguanide group for oral use.

Storage conditions

In a place protected from light at a temperature not exceeding 25˚C.

Keep out of the reach of children.

Shelf life

3 years. Do not use after expiration date.

Manufacturer

Farmasintez-Tyumen, Russia