GLUCOPHAGE 500mg film-coated tab
|Active Ingredients||500 mg metformin hydrochloride|
|Side Effects||During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite which resolve spontaneously in most cases. To prevent them, it is recommended to take metformin in 2 or 3 daily doses and to increase slowly the doses.The following adverse reactions may occur under treatment with metformin. Frequencies are defined as follows: very common: ≥1/10; common >1/100, <1/10; uncommon >1/1,000, <1/100; rare >1/10,000, <1/1,000; very rare <1/10,000.Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.Metabolism and nutrition disordersVery rare• Lactic acidosis (see section 4.4).• Decrease of vitamin B12 absorption with decrease of serum levels during long-term use of metformin. Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia.Nervous system disordersCommon• Taste disturbanceGastrointestinal disordersVery common• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.Hepatobiliary disordersVery rare• Isolated reports of liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.Skin and subcutaneous tissue disordersVery rare• Skin reactions such as erythema, pruritus, urticaria|
|Contraindications||• Hypersensitivity to metformin or to any of the excipients listed in section 6.1.• Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).• Diabetic pre-coma.• Severe renal failure (GFR < 30 mL/min).• Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.• Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.• Hepatic insufficiency, acute alcohol intoxication, alcoholism.|
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