Merifatin, 1000 mg 60 pcs

Hypoglycemic agent of the group of biguanides for oral use.

Indications

Type 2 diabetes mellitus, especially in obese patients 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 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.

Active ingredient

Composition

1 tablet contains:

The active ingredient:

metformin hydrochloride 1000 mg.

Associates:

Hypromellose 2208 10.0 mg;

Povidone K90 (collidone 90F) 40.0 mg;

Sodium stearyl fumarate 10.0 mg.

Water-soluble film coating:

Hypromellose 2910 14.0 mg; polyethylene glycol 6000 (macrogol 6000) 1.8 mg; polysorbate 80 (tween 80) 0.2 mg; titanium dioxide 4.0 mg.

Special Instructions

The duration of treatment

Metformin should be taken daily, without interruption. If treatment is discontinued, the patient should tell the physician.

Contraindications

– Hypersensitivity to metformin or any excipient;

– diabetic ketoacidosis, diabetic precoma, coma;

– renal insufficiency or impaired renal function (creatinine clearance less than 45 ml/min);

– acute conditions with risk of renal impairment: dehydration (in diarrhea, vomiting), severe infectious diseases, shock;

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

– major surgical operations and trauma when insulin therapy is indicated (see section “Indications”).

– hepatic insufficiency, liver dysfunction;

– chronic alcoholism, acute alcohol poisoning;

– pregnancy;

– lactoacidosis (including

– use less than 48 hours before and 48 hours after radioisotopic or radiological studies with iodine contrast agent (see section “Interaction with other medicinal products”);

– keeping a hypocaloric diet (less than 1000 kcal/day).

Side effects

The frequency of side effects of the drug is rated as follows: very frequently (≥1/10); frequently (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1/10000, <1/1000); very rarely (<1/10000).

The side effects are presented in decreasing order of importance.

Metabolism and nutrition: very rare – lactoacidosis (see “Special Precautions”). With prolonged use of metformin a decrease in absorption of vitamin B12 may be observed. If megaloblastic anemia is detected, the possibility of this etiology should be considered.

Nervous system disorders: often – disorders of taste.

Gastrointestinal tract: very often – nausea, vomiting, diarrhea, abdominal pain, lack of appetite. They occur most frequently during the initial period of treatment and in most cases disappear spontaneously. To prevent symptoms, it is recommended that metformin be taken 2 or 3 times daily with or after meals. Slowly increasing the dose may improve gastrointestinal tolerance.

Skin and subcutaneous tissue disorders: very rare – skin reactions such as erythema, pruritus, rash.

Liver and biliary tract disorders: very rare – liver dysfunction or hepatitis; these adverse events disappear completely after cancellation of metformin.

Published data, post-marketing data, and controlled clinical trials in a limited pediatric population in the 10-16 year age group show that side effects are similar in nature and severity to those in adult patients.

Similarities