GLUCOPHAGE 850 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Merck (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 850 mg

Authorization status:

Registered

Authorization date:

1977-01-04

Patient Information leaflet

GLUCOPHAGE XR 500 MG, XR 750 MG AND XR 1000 MG
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S3
1. NAME OF THE MEDICINE
Glucophage XR 500 mg (prolonged release tablet)
Glucophage XR 750 mg (prolonged release tablet)
Glucophage XR 1000 mg (prolonged release tablet)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release GLUCOPHAGE
XR 500 MG tablet contains 500 mg metformin
hydrochloride corresponding to 390 mg metformin base.
Each prolonged release GLUCOPHAGE
750 XR MG tablet contains 750 mg metformin
hydrochloride corresponding to 585 mg metformin base.
Each prolonged release GLUCOPHAGE
XR 1000 MG tablet contains 1 000 mg metformin
hydrochloride corresponding to 780 mg metformin base.
Sugar-free.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Glucophage XR 500 mg:
White to off-white, round, biconvex tablet of 12 mm diameter,
debossed on one side with “500”.
Glucophage XR 750 mg:
White to off-white, capsule-shaped, biconvex tablet of 19 mm
length, debossed on one side with “750” and on the other side with
“Merck”.
Glucophage XR 1000 mg:
White to off-white, capsule-shaped, biconvex tablet of 22 mm
length, debossed with “1000” on one face and “Merck” on the
other
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Risk reduction or delay of the onset of type 2 diabetes mellitus in
adult, overweight patients
with prediabetes (IGT* and/or IFG*, and/or increased HbA1c) and
additional risk factors**,
in whom lifestyle change has not resulted in adequate glycaemic
control.
Lifestyle modifications should be continued when metformin is
initiated, unless the patient
is unable to do so because of medical reasons.
*IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose
** Identified risk factors include obesity, age, hypertension,
cardiovascular disease, family
history of diabetes, dyslipidaemia, gestational diabetes, and
Polycystic ovary syndrome (PCOS).
•
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when
dietary

Summary of Product characteristics

GLUCOPHAGE 500 MG, 850 MG AND 1 000 MG PI
SCHEDULING STATUS: S3
1. NAME OF THE MEDICINE
GLUCOPHAGE 500 MG TABLET
GLUCOPHAGE 850 MG TABLET
GLUCOPHAGE 1 000 MG TABLET
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each GLUCOPHAGE
500 MG tablet contains 500 mg metformin hydrochloride
corresponding to 390 mg metformin base.
Each GLUCOPHAGE
850 MG tablet contains 850 mg metformin hydrochloride
corresponding to 663 mg metformin base.
Each GLUCOPHAGE
1 000 MG tablet contains 1 000 mg metformin hydrochloride
corresponding to 780 mg metformin base.
Sugar-free.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
GLUCOPHAGE 500 mg: White, round, biconvex, film-coated tablets.
GLUCOPHAGE 850 mg: White, round, convex, film-coated tablets.
GLUCOPHAGE 1 000 mg: White, oval, biconvex, bisected, film-coated
tablets with
“1000” embossed on one side.
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 film-coated tablets may be used as monotherapy
or in
combination with other oral antidiabetic medicines or with insulin.
•
In children over 12 years of age and adolescents with type 2 diabetes
mellitus,
Glucophage
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 immediate-release
as first-line
therapy after diet failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
It is important that Glucophage tablets be taken in divided doses with
meals.
MONOTHERAPY OR COMBINATION WITH OTHER ORAL ANTIDIABETIC MEDICINES
ADULTS
•
Initially, one 500 mg tablet three times a day, or one 850 mg or 1 000
mg tablet
twice a day, with or after meals.
•
After 10 to 15 days the dose should be adjusted according to blood
glucose
measurements.
A
slow
increase
in
dose
may
improve
gastroint