1. NAME OF THE MEDICINAL
GLUCOPHAGE 850 mg film-coated
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
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
4.2 Posology and method of
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
* 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.
-- Hypersensitivity to metformin
hydrochloride or to any of the excipients.
-- Diabetic ketoacidosis,
-- Renal failure or renal
dysfunction ( creatinine clearance < 60 mL/min ).
-- Acute conditions with the
potential to alter renal function such as :
-- severe infection,
-- intravascular administration
of iodinated contrast agents ( see 4.4 Warnings and special precautions for
-- Acute or chronic disease which
may cause tissue hypoxia such as :
-- cardiac or respiratory
--recent myocardial infarction,
-- Hepatic insufficiency, acute
alcohol intoxication, alcoholism