GLUCOPHAGE 1000 mg tablet

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

METFORMIN HYDROCHLORIDE

Доступна з:

MERCK SDN. BHD.

ІПН (Міжнародна Ім'я):

METFORMIN HYDROCHLORIDE

Одиниць в упаковці:

120 Tablets

Виробник:

MERCK SANTE S.A.S.

інформаційний буклет

Consumer Medication Information Leaflet (RiMUP)
1
GLUCOPHAGE
®
FILM-COATED TABLET
Metformin hydrochloride (500mg, 850mg, 1000mg)
What is in this leaflet
1.
What Glucophage is used for
2.
How Glucophage works
3.
Before you take Glucophage
4.
How to take Glucophage
5.
While you are taking it
6.
Side effects
7.
Storage and Disposal of
Glucophage
8.
Product Description
9.
Manufacturer and Product
registration holder
10. Date of revision
What Glucophage is used for
Glucophage contains metformin, a
medicine to treat diabetes. It belongs
to a group of medicines called
biguanides.
Glucophage is used to treat patients
with type 2 diabetes (also called
'non-insulin dependent diabetes')
when diet and exercise alone have
not been enough to control your
blood glucose levels. It is used
particularly in overweight patients.
Adults can take Glucophage on its
own or together with other medicines
to treat diabetes (medicines taken by
mouth or insulin).
Children 10 years and over and
adolescents can take Glucophage on
its own or together with insulin.
How Glucophage works
Insulin is a hormone produced by the
pancreas that makes your body take
in glucose (sugar) from the blood.
Your body uses glucose to produce
energy or stores it for future use.
If you have diabetes, your pancreas
does not make enough insulin or
your body is not able to use properly
the insulin it produces. This leads to
a high level of glucose in your blood.
Glucophage helps to lower your
blood glucose to as normal a level as
possible.
If you are an overweight adult,
taking Glucophage over a long
period of time also helps to lower the
risk of complications associated with
diabetes. Glucophage is associated
with either a stable body weight or
modest weight loss.
Before you take Glucophage
- When you must not take it
Do not take Glucophage
 if you are allergic
(hypersensitive) to metformin or
any of the other ingredients of
this medicine (see Product
Description, Ingredients)
 if you have severely
reduced kidney function
 if you have uncontrolled diabetes,

Характеристики продукта

NAME OF THE MEDICINAL PRODUCT
GLUCOPHAGE® 1000 mg film -coated tablet
Q
UALI TATI VE AND Q UANTI TATI VE COMP OS I TI ON
Each film -coated tablet of GLUCOPHAGE 1000 mg contains metformin hydrochloride 1000mg
corresponding to 780 mg metformin base.
F
or a full list of excipients, see List of excipients
P
HARMACEUTI CAL FORM
Film -coated tablet.
White, oval, biconvex film -coated tablet with a score line on both sides with « 1000 » eng raved on
one side. The tablet can be divided into equal halves.
C
LI NI CAL PAR TI CULARS
Therapeutic indications
Treatment of type 2 diabetes mellitus, when dietary manag ement and exercise alone does not result
in adequate g lycemic control.
- In adults, GLUCOPHAGE® 1000 mg film -coated tablet may be used as monotherapy or in
combination with other oral anti -diabetic ag ents or with insulin.
- I n children from 10 years of ag e and adolescents, GLUCOPHAGE® 1000 mg film -coated tablet
may be used as monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweig ht type 2 diabetic adult patients
treated with metformin hydrochloride a s first-line therapy after diet failure (see Pharmacodynamic
properties) .
P
osology and method of administration
Adults with normal renal function (GFR ≥ 90 mL/min):
Monotherapy and combination with other oral antidiabetic agents :
- The usual starting dose is 500 mg or 850 mg 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 meas urements. A slow increase of dose may improve gastrointestinal tolerability. In
patients receiving a hig h metformin hydrochloride dose (2 t o 3 g ra ms per da y), it is possible t o
replace two Glucophag e 500 mg , film -coated tablets with one Glucophag e 1000 mg , film -coated
tablet.
- The maximum recommended dose of metformin hydrochloride is 3 g daily , taken as 3 divided
doses.
- I f transfer from another oral antidiabetic ag ent is intended: discontinue the other ag e