GLUCOPHAGE 500 mg Merck Serono

Transcription

1 GLUCOPHAGE 500 mg Film-coated tablets Composition Film-coated tablets containing 500 mg of metformin (INN) hydrochloride (equivalent to 390 mg of metformin Excipients Polyvidone K 30, magnesium stearate, hypromellose, q.s. one film-coated tablet of 529 mg. Pharmaceutical form Film-coated tablet - Pack of 50 tablets = 25 g of metformin HCI per - Pack of 100 tablets = 50 g of metformin HCI per - Pack of 500 tablets = 250 g of metformin HCI per pack Pharmacotherapeutic category ORAL ANTIDIABETIC AGENT (A: gastrointestinal tract and metabolism). As an adjunct to adequate dietary management, Glucophage 500 mg is an oral antidiabetic agent (biguanide) intended for the treatment of adult-onset diabetes. In some cases, it may be used in association with insulin. Contraindications This drug MUST NOT BE USED in the following kidney function with increased levels of creatinine in the blood), - infectious diseases with high (respiratory tract infection, urinary tract infection), - persistent diarrhea, repeated vomiting, - before and for 2 days after a surgical procedure, - before or at the time of radiologic tests involving the use of intravascular iodinated contrast agents (for example, intravenous urography, angiogra- phy). The drug will be reinstituted only after renal function has been found to be normal, - severe destabilisation of diabetes (ketoacidosis), - heart failure, respiratory insufficiency, - hepatic insufficiency (impairment of liver function), - excessive intake of alcoholic beverages, - pregnancy and breast-feeding. Side Effects This drug can, in some people, cause more or less disagreeable effects. Gastrointestinal discomfort (nausea, vomiting, diarrhea) may occur at the beginning of treatment, especially if Glucophage 500 mg tablets are not taken with meals. These symptoms are usually temporary, lasting about 10 days, and can be reduced by taking the tablets during or at the end of meals. Should symptoms persist, stop taking the treatment and consult your doctor. ketoacidosis or lactic acidosis) requiring a specific treatment. If this occurs you should immediately stop taking Glucophage and consult your doctor promptly. REPORT ANY UNDESIRABLE OR DISTRESSING EFFECT WHICH HAS NOT BEEN MENTIONED IN THIS PACKAGE INSERT TO YOUR DOCTOR OR YOUR PHARMACIST. Warnings ketoacidosis or lactic acidosis) requiring a specific treatment. If this occurs, you should stop taking Glucophage immediately and consult your doctor promptly.

2 GLUCOPHAGE 500 mg - p.2/2 Precautions Your doctor will order periodic laboratory tests to determine the levels of creatinine in your blood in order to check your kidney function, which must be adequate since oral antidiabetic agents are substantially eliminated by the kidneys. Therefore, you should drink at least 1.5 liters of fluids every day. Certain illnesses or medications (corticosteroids oral contraceptives, some diuretics) may cause a more or less severe destabilisation of diabetes requiring temporary recourse to insulin therapy. You should inform your doctor of any other treatments you are receiving and of any infectious or viral illness such as flu, respiratory tract infection or urinary tract infection. If you are scheduled to undergo radiologic studies involving the use of iodinated contrast agents, such as intravenous urography or angiography, your doctor will ask you to stop the treatment with Glucophage prior to or at the time of the test and will only resume the treatment after making sure that your kidneys are functioning normally. If you are hospitalised for tests, a surgical procedure, or complications such as heart disease, tell your doctor that you are taking Glucophage. Avoid excessive intake of alcoholic beverages. IF IN DOUBT, DO NOT HESITATE TO SEEK THE ADVICE OF YOUR PHARMACIST OR YOUR DOCTOR. Pregnancy During pregnancy, the treatment of diabetes is based on insulin therapy. If you discover that you are pregnant while taking Glucophage, your treatment will be replaced by insulin. Inform your doctor so that he may make the necessary changes to your treatment. Inform your doctor if you wish to become pregnant. As a general rule, if you are pregnant or breastfeeding you should always ask your doctor for advice before taking a medication. Effect on Ability to Drive and Use Machines When used alone, Glucophage does not cause hypoglycemia. Therefore, there is no particular risk when driving or using machines. Intake or use of other medications Inform your doctor or your pharmacist if you are taking or have recently taken another drug, i.e. corticosteroids, anti hypertensive agents of the ACE inhibitor class (angiotensin-converting enzyme inhibitors), diuretics, ritodrine, salbutamol or terbutaline, iodized contrast media or medications containing alcohol, even if an over-the-counter medication is involved. Storage No special requirements for storage. Do not use after the expiry date shown on the outer packaging. Dosage and Administration The dosage of Glucophage 500 mg is determined by your doctor on an individual basis according to the results of laboratory blood glucose measurements. In general, the average dosage is 1 tablet one to three times a day. Method and route of administration This medication is administered by mouth. Oral route. Frequency and 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 two tablets daily, take 1 tablet with breakfast and 1 tablet with dinner. IN ALL CASES PATIENTS SHOULD STRICTLY COMPLY WITH THEIR DOCTOR S PRESCRIPTION. Duration of treatment Glucophage must be taken daily without interruption, except if specifically directed by your doctor. If you have forgotten to take a Glucophage 500 mg film-coated tablet: Take the next dose at the usual time. Do not double the dose of Glucophage. Packaging t: 50, 100, 500.

3 GLUCOPHAGE 850 mg Pharmaceutical form: Glucophage 850 mg tablets are white, circular, convex and film-coated. Film-coated tablets containing 850 mg metformin (INN) hydrochloride (equivalent to 663 mg metformin As an adjunct to adequate diet and exercise Glucophage 850 mg is an oral Anti-diabetic agent (biguanide) intended for the treatment of type 2 diabetes. In adults, Glucophage 850 mg may be given alone or with oral anti-diabetic agents, or with insulin. In children from 10 years old and adolescents, Glucophage 850 mg may be given alone or with insulin. A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet therapy Dosage The dosage of Glucophage 850 mg is determined by your doctor on an individual basis according to the results of laboratory blood glucose measurement. The initial dosage is usually one tablet of Glucophage 850 mg once daily in children from 10 years old and adolescents and one tablet of Glucophage 850 mg 2 or 3 times daily in adults. The maximum recommended dose is 2 g daily in children and 3 g daily in adults (taken as 2 or 3 divided doses). In case of decreased renal function, the dosage should be adjusted based on renal function. Contra-indications This drug MUST NOT BE USED in the following - known hypersensitivity to metformin hydrochloride or any of the product ingredients, - severe destabilisation of diabetes (ketoacidosis or pre-coma), kidney function with increased blood creatinine levels or decreased creatinine clearance <60 ml/mn), - infectious diseases (for example respiratory tract infection, urinary tract infection), - following an X-ray examination involving the use of iodinated contrast media (for example intravenous urography, angiography), - disease which may cause tissue hypoxia (heart failure, recent myocardial infarction, respiratory insufficiency, shock), - hepatic insufficiency (impaired liver function), - persistent or severe diarrhoea, recurrent vomiting, - excessive consumption of alcoholic beverages, - during breast-feeding.

4 GLUCOPHAGE 1000 mg Film-coated tablets Composition Film-coated tablets containing 1000 mg of metformin (INN) hydrochloride (equivalent to 780 mg of metformin Excipients Polyvidone K 30, magnesium stearate, Opadry clear YS , q.s. one film-coated tablet of 1071 mg. Pharmaceutical form Film-coated tablets. - Pack of 30 tablets = 30 g of metformin HCI per pack - Pack of 60 tablets = 60 g of metformin HCI per Pharmacotherapeutic category ORAL ANTIDIABETIC AGENT (AlOBA02: gastrointestinal tract and metabolism). 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. Contraindications This drug MUST NEVER BE USED in the following - Known hypersensitivity to metformin hydrochloride or any of the product ingredients, - severe destabilisation of diabetes (ketoacidosis), 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. Side Effects As with all medications, Glucophage 1000 mg filmcoated tablets, can cause undesirable effects. Gastrointestinal discomfort (nausea, vomiting, diarrhea) may occur at the beginning of treatment, especially if Glucophage 1000 mg tablets are not taken with meals. These symptoms are generally transient, lasting about 10 days, and can be reduced by taking the tablets with or after meals. Should symptoms persist, stop taking the treatment and consult your doctor. Vomiting, abdominal pain accompanied by muscle cramps and/or a general feeling of malaise with severe fatigue occurring during therapy may be signs of serious destabilisation of your diabetes (diabetic ketoacidosis or lactic acidosis) requiring specific treatment. If this occurs you should stop taking Glucophage immediately and consult your doctor promptly. REPORT ANY UNDESIRABLE OR DISTRESSING EFFECT WHICH HAS NOT BEEN MENTIONED IN THIS PACKAGE INSERT TO YOUR DOCTOR OR PHARMACIST. Warnings ketoacidosis or lactic acidosis) requiring specific treatment. If this occurs, you should stop taking Glucophage immediately and consult your doctor promptly. Precautions Your doctor will prescribe periodic laboratory tests (to determine your blood creatinine levels) in order to check your kidney function, which must be ade-

5 GLUCOPHAGE 1000 mg - p.2/2 quate since oral antidiabetic agents are excreted mainly by the kidneys. Certain illnesses or medications (corticosteroids and certain diuretics, ritodrine, salbutamol, terbutaline and ACE inhibitors) may cause more or less severe destabilisation of diabetes. You should inform your doctor of any other treatment you are receiving and of any infectious illnesses such as influenza, respiratory tract infection or urinary tract infection. If you are scheduled to undergo X-ray examinations involving the use of iodized contrast media, such as intravenous urography or angiography, your doctor will ask you to discontinue treatment with Glucophage prior to or at the time of the test and will not resume treatment until 48 hours after the test, after ensuring that your kidneys are functioning normally. If you are hospitalised for tests, a surgical procedure, or for any other reason, advise your doctor that you are taking Glucophage. Avoid consumption of alcoholic beverages. Pregnancy During pregnancy, treatment of diabetes is based on insulin therapy. If you discover that you are pregnant while taking Glucophage, your treatment will be replaced by insulin. Inform your doctor so that he may make the necessary changes to your treatment. Inform your doctor if you wish to become pregnant. Breastfeeding This drug is contraindicated during breast-feeding. As a general rule, if you are pregnant or breastfeeding you should always ask your doctor for advice before taking a medication. Effect on Ability to Drive and Use Machines When used alone, Glucophage does not cause hypoglycemia. Consequently, there is no particular risk when driving or using machines. However, in association with other antidiabetic agents (sulphonylurea, hypoglycemic agents, insulin, repaglinide), it is important to be aware of the onset of hypoglycemia, and of its effects on concentration. Intake or use of other medications Inform your doctor or your pharmacist if you are taking or have recently taken another drug, i.e. corticosteroids, anti hypertensive agents of the ACE inhibitor class (angiotensin-converting enzyme inhibitors), diuretics, ritodrine, salbutamol or terbutaline, iodized contrast media or medications containing alcohol, even if an over-the-counter medication is involved. Storage No special requirements for storage. Do not use after the expiry date shown on the outer packaging. Dosage and Administration 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). Method and route of administration Oral route. Frequency and 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 two tablets daily, take 1 tablet with breakfast and I tablet with your evening meal. IN ALL CASES PATIENTS SHOULD STRICTLY COMPLY WITH THEIR 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 1000 mg filmcoated tablet: Take the next dose at the usual time. Do not double the dose of Glucophage 1000 mg filmcoated tablets. If you have taken more Glucophage 1000 mg film-coated tablets than indicated: Consult your doctor or pharmacist immediately. Packaging t: 30, 60.