Composition
1 tablet contains:
Active ingredient:
metformin hydrochloride 500 mg.
Auxiliary substances:
hypromellose 2208 5.0 mg;
povidone K 90 (collidone 90F) 20.0 mg;
sodium stearyl fumarate 5.0 mg.
Water-soluble film shell:
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.
Clinical pharmacology
Hypoglycemic agent of the biguanide group for oral use.
Indications
Type 2 diabetes mellitus, especially in obese patients, when diet therapy and exercise are ineffective:
• 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.
Prevention of type 2 diabetes in prediabetic patients with additional risk factors for developing type 2 diabetes, in whom lifestyle changes did not allow achieving adequate glycemic control.
Contraindications
• Hypersensitivity to Metformin or to any accessory ingredient;
• diabetic ketoacidosis, diabetic precoma, coma;
• renal failure or impaired renal function (creatinine clearance less than 45 ml/min);
• acute conditions, which are accompanied with the risk of developing kidney problems: dehydration (diarrhea, vomiting), severe infection, shock;
• symptomatic manifestations of acute or chronic diseases that may lead to the development of tissue hypoxia (in volume 4 include, acute heart failure, chronic heart failure with unstable hemodynamic, respiratory failure, acute myocardial infarction);
• extensive surgery and trauma, when shown holding insulin (see section “Special instructions”);
• liver failure, liver dysfunction;
• chronic alcoholism, acute alcohol poisoning;
• pregnancy;
• lactic acidosis (including history);
• application in less than 48 hours before and within 48 hours after the radioisotope or radiological examinations with use of iodinated contrast agents (see section “Interaction with other medicines”);
• adherence to a reduced-calorie diet (less than 1000 kcal/day).
Side effects
The frequency of side effects of the drug is estimated as follows: very common (≥1/10); common (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (
Side effects are presented in descending order of significance.
From the side of metabolism and nutrition: very rarely – lactic acidosis (see “Special instructions”). With prolonged use of metformin, there may be a decrease in the absorption of vitamin B12. If megaloblastic anemia is detected, it is necessary to consider the possibility of such an etiology.
From the nervous system: often-a violation of taste.
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 pass spontaneously. To prevent symptoms, it is recommended to take metformin 2 or 3 times a day during or after a meal. Slowly increasing the dose may improve gastrointestinal tolerance.
From the skin and subcutaneous tissue: very rarely-skin reactions, such as erythema, pruritus, rash. Liver and biliary tract disorders: very rarely – impaired liver function or hepatitis; after discontinuation of metformin, these adverse events completely disappear.
Published data, post-marketing data, and controlled clinical trials in a limited pediatric population aged 10-16 years indicate that side effects are similar in nature and severity to those in adult patients.
Special instructions
Duration of treatment
Metformin should be taken daily, without interruption. If treatment is discontinued, the patient should inform the doctor.
Storage conditions
Store in a dark place at a temperature not exceeding 25C.
Keep out of the reach of children.
Shelf
life is 3 years. Do not use after the expiration date.
Active ingredient
Metformin
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
Children as prescribed by a doctor, Children over 10 years of age, Adults as prescribed by a doctor
Indications
Type 2 Diabetes
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