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GlucophageGlucophage

Metformin

 

1. NAME OF THE MEDICINAL PRODUCT

GLUCOPHAGE 850 mg film-coated tablet

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF THE ACTIVE INGREDIENT

Each film-coated tablet of GLUCOPHAGE 850mg contains metformin hydrochloride 850mg corresponding to metformin base 663 mg.

 

3. PHARMACEUTICAL FORM

Film-coated tablet.

 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of type 2 diabetes mellitus, when dietary management and exercise alone does not result in adequate glycemic control.

* In adults, GLUCOPHAGE 850mg film-coated tablet 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, GLUCOPHAGE 850mg film-coated tablet may be used as monotherapy or combination 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 failure ( see 5.1 Pharmacodynamic properties ).

 

In Type 1 diabetes, GLUCOPHAGE may be given as an adjuvant to patients whose diabetic are poorly controlled.

 

4.2 Posology and method of administration

Adults

Monotherapy and combination with other oral antidiabetic agents

-- The usual starting dose is one tablet 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 is 3g daily.

 

-- If transfer from another oral antidiabetic agent is intended : discontinue the other agent and initiate metformin at the dose indicated above.

 

Combination with insulin

Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin is given at the usual starting dose of one tablet 2-3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.

 

Children and adolescents

Monotherapy and combination with insulin

* GLUCAPHAGE 850mg film-coated tablet can be used in children from 10 years of age and adolescents.

 

* The usual starting dose is one tablet of 500mg or 850mg 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 is 2g daily, taken as 2 or 3 divided doses.

 

4.3 Contradications

-- 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 4.4 Warnings and special precautions for use ).

-- 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

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