* 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) | ||
& requiring specific treatment. If this occurs, you should stop taking Glucophage i
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