Glucophage 500mg, film-coated Tablets

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

METFORMIN HYDROCHLORIDE

Boleh didapati daripada:

Merck Sante S.A.S. 37 Rue Saint Romain, 69008 Lyon, France

Kod ATC:

A10BA02

INN (Nama Antarabangsa):

METFORMIN HYDROCHLORIDE 500 mg

Borang farmaseutikal:

FILM-COATED TABLET

Komposisi:

METFORMIN HYDROCHLORIDE 500 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

DRUGS USED IN DIABETES

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2007-10-25

Risalah maklumat

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Code barre 128c centré
128c code barre position
Code barre 128c centré
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Code barre 128c centré
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Code barre 128c centré
128c code barre position
GLUCOPHAGE 500 MG, FILM-COATED TABLETS
PLEASE READ THIS LEAFLET CAREFULLY IN FULL BEFORE TAKING THIS
MEDICATION
QUALITATIVE COMPOSITION / QUANTITATIVE COMPOSITION OF ACTIVE
INGREDIENT
Film-coated tablets containing 500 mg metformin (INN) hydrochloride
(equivalent to 390 mg metformin base).
EXCIPIENTS
Povidone K 30, magnesium stearate and hypromellose.
PHARMACEUTICAL FORM
Glucophage 500 mg tablets are white, circular, convex and
film-coated. 
MANUFACTURER
Merck Santé s.a.s. - 2, rue du Pressoir Vert - 45400 Semoy - France
THERAPEUTIC INDICATIONS
As an adjunct to adequate diet and exercise Glucophage 500 mg is an
oral antidiabetic agent (biguanide) intended for the treatment of type
2 diabetes. In adults, Glucophage 500 mg 
may be given alone or with oral antidiabetic agents, or with insulin.
In children from 10 years old and adolescents, Glucophage 500 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.
CONTRA-INDICATIONS
This drug MUST NOT BE USED in the following cases:
- known hypersensitivity to metformin hydrochloride or any of the
product ingredients,
- severe destabilisation of diabetes (ketoacidosis or pre-coma),
- renal insufficiency, even if moderate (impairment of 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
myocardia

Ciri produk

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

GLUCOPHAGE 500 mg, film-coated tablet    

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One film-coated tablet contains 500 mg metformin hydrochloride
corresponding to 390 mg metformin 
base. 
For excipients, see § 6.1. 

3. 
PHARMACEUTICAL FORM 

Film-coated tablet. 
White, circular, convex film-coated tablet 

4. CLINICAL 
PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

Treatment of type 2 diabetes mellitus, particularly in overweight
patients, when dietary management 
and exercise alone does not result in adequate glycaemic control. 
•  In adults, Glucophage 500 mg 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
500 mg film-coated tablet 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 as first-line therapy after diet failure (see
5.1. Pharmacodynamic properties). 

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 3 g 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 usu