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For the full list of excipients, see section 6. Glucophage mg and mg film coated tablets.

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Name of the medicinal product. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Controlled clinical studies in a limited paediatric population aged years treated during 1 year demonstrated a similar response in glycaemic control to that seen in adults. During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite which resolve spontaneously in most cases.

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Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis see sections 4. Clinical efficacy The prospective randomised study UKPDS has established the long-term benefit of intensive blood glucose control in adult patients with type 2 diabetes.

Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis. Paediatric population Controlled clinical studies in a limited paediatric population aged years treated during 1 year demonstrated a similar response in glycaemic control to that seen in adults.

Other precautions All patients should continue their diet with a regular distribution of carbohydrate intake during the day.

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Metformin may act via 3 mechanisms: The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses. Find medicines from the same company. The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated.

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When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.

Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis. The available data in subjects with moderate renal insufficiency are scarce and no reliable estimation of the systemic exposure to metformin in this subgroup as compared to subjects with normal renal function could be made. The clinical relevance of these findings is unknown. This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: The most effective method to remove lactate and metformin is haemodialysis.

When starting or using such products in combination with metformin, close monitoring of renal function is necessary.

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These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.

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To prevent them, it is recommended to take metformin in 2 or 3 daily doses and to increase slowly the doses. Qualitative and quantitative composition 3.

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