Glucophage SR 750mg 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:

750mg

Dawa fomu:

Modified-release tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 06010202; GTIN: 5013837321519 5013837321526

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOPHAGE® SR 750MG PROLONGED-RELEASE
TABLETS
(metformin hydrochloride)
This medicine is intended for ADULT patients only
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.
The name of your medicine is Glucophage SR 750mg prolonged-release
tablets, but will be referred to as Glucophage SR throughout the
remainder of the leaflet.
Your medicine is also available in the following strengths, 500mg and
1000mg.
WHAT IS IN THIS LEAFLET:
1. What Glucophage SR is and what it is used for
2. What you need to know before you take Glucophage SR
3. How to take Glucophage SR
4. Possible side effects
5. How to store Glucophage SR
6. Content of the pack and other information
1. WHAT GLUCOPHAGE SR IS AND WHAT IT IS USED FOR
Glucophage SR prolonged release tablets contain the active ingredient
metformin hydrochloride and belong to a group of medicines called
biguanides, used in the treatment of Type 2 (non-insulin dependent)
diabetes mellitus.
Glucophage SR is used together with diet and exercise to lower the
risk
of developing Type 2 diabetes in overweight adults, when diet and
exercise alone for 3 to 6 months have not been enough to control blood
glucose (sugar). You are at high risk of developing Type 2 diabetes if
you
have additional conditions like high blood pressure, age above 40
years,
an abnormal amount of lipids (fat) in the blood or a history of
diabetes
during pregnancy.
The medicine is particularly effective if you are aged below 45 years,
are
very overweight, have high blood glucose levels after

Tabia za bidhaa

OBJECT 1
GLUCOPHAGE SR 500MG, 750MG AND 1000MG
PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 23-May-2017 | Merck
1. Name of the medicinal product
Glucophage SR 500 mg prolonged release tablets
Glucophage SR 750 mg prolonged release tablets
Glucophage SR 1000 mg prolonged release tablets
2. Qualitative and quantitative composition
500 mg: One prolonged release tablet contains 500mg metformin
hydrochloride corresponding to 390 mg
metformin base.
750 mg: One prolonged release tablet contains 750 mg metformin
hydrochloride corresponding to 585 mg
metformin base.
1000 mg: One prolonged release tablet contains 1000 mg metformin
hydrochloride corresponding to 780
mg metformin base.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release tablet.
500 mg: White to off-white, round, biconvex tablet, debossed on one
side with '500'.
750 mg: White capsule-shaped, biconvex tablet, debossed on one side
with '750' and on the other side
with 'Merck'.
1000 mg: White to off-white capsule-shaped, biconvex tablet, debossed
on one side with '1000' and on the
other side with 'MERCK'.
4. Clinical particulars
4.1 Therapeutic indications
• Reduction in the risk or delay of the onset of type 2 diabetes
mellitus in adult, overweight patients with
IGT* and/or IFG*, and/or increased HbA1C who are:
- at high risk for developing overt type 2 diabetes mellitus (see
section 5.1) and
- still progressing towards type 2 diabetes mellitus despite
implementation of intensive lifestyle change
for 3 to 6 months
Treatment with Glucophage SR must be based on a risk score
incorporating appropriate measures of
glycaemic control and including evidence of high cardiovascular risk
(see section 5.1).
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
• Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary
m