Glucophage 500mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Metformin hydrochloride

Inapatikana kutoka:

Merck Serono Ltd

ATC kanuni:

A10BA02

INN (Jina la Kimataifa):

Metformin hydrochloride

Kipimo:

500mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 06010202; GTIN: 5013675000034

Taarifa za kipeperushi

PAGE 1
MUP-000798
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or
pharmacist.
•
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
•
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Glucophage is and what it is used for
2.
What you need to know before you take Glucophage
3.
How to take Glucophage
4.
Possible side effects
5.
How to store Glucophage
6.
Contents of the pack and other information
1.
WHAT GLUCOPHAGE IS AND WHAT IT IS USED FOR
Glucophage contains metformin, a medicine to treat
diabetes. It belongs to a group of medicines called
biguanides.
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.
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

Tabia za bidhaa

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 the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, circular, convex film-coated tablets 11 mm in diameter and 5.7
mm high,
engraved with GL 500_. _
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 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 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 section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
_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 measurements.
A slow increase of dose may improve gastrointestinal tolerability.
The maximum recommended dose of metformin hydrochloride is 3 g daily,
taken as 3 divided
doses.
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 hydrochloride is given at the usual starting dose
of 500 mg or 850 mg 2 or
3 times daily, while insulin dosage is adjusted on t