Metformin 500mg medicine

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Metformin hydrochloride 500 mg film-coated tablets2. Qualitative and quantitative compositionEach film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin.For a full list of excipients, see section 6.1.3. Pharmaceutical formFilm-coated tablet.White, round, biconvex, film-coated tablets with 'A' debossed on one side and '60' debossed on the other side. 4. Clinical particulars4.1 Therapeutic indicationsTreatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycemic control. • In adults, Metformin film-coated tablets may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin.• In children from 10 years of age and adolescents, Metformin hydrochloride film-coated tablets may be used as monotherapy or in combination with insulin.A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin hydrochloride as first-line therapy after diet failure (see section 5.1).4.2 Posology and method of administrationAdults:

The usual starting dose is 500mg or 850mg metformin hydrochloride 2 or 3 times daily given during or after meals.After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses.If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin hydrochloride at the dose indicated above.Combination with insulin:

Metformin hydrochloride and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual starting dose of 500mg or 850mg metformin hydrochloride 2or3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.Elderly:

Due to the potential for decreased renal function in elderly subjects, the metformin hydrochloride dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see section 4.4).Children and adolescents:

Monotherapy and combination with insulin• Metformin hydrochloride film-coated tablets can be used in children from 10 years of age and adolescents.• The usual starting dose is 500 mg or 850 mg metformin hydrochloride once daily, given during meals or after meals.After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 2 g daily, taken as 2 or 3 divided doses.4.3 Contraindications• Hypersensitivity to metformin hydrochloride or to any of the excipients.• Diabetic ketoacidosis, diabetic pre-coma.• Renal failure or renal dysfunction (creatinine clearance < 60 ml/min).• Acute conditions with the potential to alter renal function such as:   dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4).• Acute or chronic disease which may cause tissue hypoxia such as:   cardiac or respiratory failure, recent myocardial infarction,shock• Hepatic insufficiency, acute alcohol intoxication, alcoholism• Lactation.4.4 Special warnings and precautions for useLactic acidosis:

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Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin hydrochloride accumulation. Reported cases of lactic acidosis in patients on metformin hydrochloride have occurred primarily in diabetic patients with significant renal failure. The incidence of lactic acidosis can and should be reduced by assessing also other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia.Diagnosis:

The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps with digestive disorders as abdominal pain and severe asthenia.Lactic acidosis is characterised by acidotic dyspnea, abdominal pain and hypothermia followed by coma. Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5mmol/l, and an increased anion gap and lactate/pyruvate ratio. If metabolic acidosis is suspected, metformin hydrochloride should be discontinued and the patient should be hospitalised immediately (see section 4.9).Renal function:

As metformin hydrochloride is excreted by the kidney, serum creatinine levels should be determined before initiating treatment and regularly thereafter:* at least annually in patients with normal renal function,* at least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly subjects.Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diueretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug.Administration of iodinated contrast agent:

As the intravascular administration of iodinated contrast materials in radiologic studies can lead to renal failure, metformin hydrochloride must be discontinued prior to, or at the time of the test and not be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).Surgery:

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Metformin hydrochloride must be discontinued 48 hours before elective surgery under general, spinal or peridural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established.Children and adolescents:

The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin hydrochloride is initiated. No effect of metformin hydrochloride on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin hydrochloride on these parameters in metformin hydrochloride-treated children, especially pre-pubescent children, is recommended. Children aged between 10 and 12 years:

Only 15 subjects aged between 10 and 12 years were included in the controlled clinical studies conducted in children and adolescents. Although efficacy and safety of metformin hydrochloride in these children did not differ from efficacy and safety in older children and adolescents, particular caution is recommended when prescribing to children aged between 10 and 12 years.Other precautions: