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* Composition: Each film-coated tablet contains:
& Metformin hydrochloride 1000 mg (equivalent to metformin base 780 mg).
* Therapeutic indications: As an adjunct to adequate dietary management, GLUCOPHAGE 1000 mg is an oral antidiabetic agent
& (biguanide) intended for the treatment of adult diabetes. In some cases, it may be used in association with insulin.
* Pediatic indication: In children from 10 years of age and adolescents, GLUCOPHAGE 1000 mg, film-coated may be used
& as monotherapy or in combination with insulin.
* Contra-indications: This drug MUST NEVER BE USED in the following cases:
– Known hypersensitivity to metformin hydrochloride or any of the product ingredients,
– Severe destabilisation of diabetes (ketoacidosis),
– Renal insufficiency, even if moderate (impairment of kidney function with increased blood creatinine levels),
– Infectious diseases (respiratory tract infection, urinary tract infection),
– During the two days following an X-ray examination involving the use of iodinated contrast media (for example,
& intravenous urography, angiography),
– Heart failure, respiratory insufficiency,
– Hepatic insufficiency (impaired liver function),
– Persistent diarrhea, recurrent vomiting,
– Excessive consumption of alcoholic beverages,
– During breast-feeding.
* Dosage:
– The dosage of GLUCOPHAGE 1000 mg is determined by your doctor on an individual basis according to the results
& of laboratory blood glucose measurement.
– In general, the average dosage is 2 tablets per day (taken with or after meals).
– For children from 10 years of age and adolescents, the maximum recommended dose of metformin is 2 g daily, taken
& as 2 or 3 divided doses.
– Frequency && time at which the drug should be taken: Swallow the tablets without chewing during or at the end of meals.
& For example, for a dosage of 2 tablets daily take 1 tablet with breakfast and 1 tablet with your evening meal.
& IN ALL CASES YOU SHOULD STRICTLY COMPLY YOUR DOCTOR’S PRESCRIPTION.
– Duration of treatment: Glucophage must be taken daily without interruption, except if specifically indicated by your doctor.
& If you have forgotten to take a GLUCOPHAGE 1000mg film-coated tablet: Take the next dose at the usual time. Do not double
& the dose of Glucophage 1000mg film-coated tablets.
& If you have taken more GLUCOPHAGE 1000mg film-coated tablets than indicated: Consult your doctor or pharmacist immediately.
* Special warnings: Vomiting, abdominal pain accompanied by muscle cramps and/or a general feeling of malaise with severe
& fatigue occuring during therapy may be signs of serious destablisation of your diabetes (diabetic ketoacidosis or lactic acidosis)
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