Metabet SR

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

metformin (metformin hydrochloride)

Available from:

Morningside Pharmaceuticals Ltd

INN (International Name):

metformin (metformin hydrochloride)

Dosage:

1000mg

Pharmaceutical form:

tablets prolonged-release

Prescription type:

Prescription

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Metabet SR 1000 mg 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness 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 Metabet SR is and what it is used for
2.
What you need to know before you take Metabet SR
3.
How to take Metabet SR
4.
Possible side effects
5.
How to store Metabet SR
6.
Contents of the pack and other information
Metabet
SR
1000mg
prolonged
release
tablets
contain
the
active
ingredient metformin hydrochloride and belongs to a group of medicines
called biguanides which are used in the treatment of diabetes.
Metabet SR is used for the treatment of Type 2 (non-insulin dependent)
diabetes mellitus when diet and exercise changes alone have not been
enough to control blood glucose (sugar).
Insulin is a hormone that enables body tissues to take glucose from
the
blood and use it for energy or for storage for future use. People with
Type 2
diabetes do not make enough insulin in their pancreas or their body
does
not respond properly to the insulin it does make. This causes a
build-up of
glucose in the blood which can cause a number of serious long-term
problems so it is important that you continue to take your medicine,
even
though you may not have any obvious symptoms. Metabet SR makes the
body more sensitive to insulin and helps return to normal the way your
body
uses glucose.
Metabet SR is associated with either a stable body weight or modest
weight
loss.
Metabet SR prolonged release tablets are specia

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metabet SR 1000 mg prolonged release tablets
Bolamyn SR 1000 mg prolonged release tablets
Metformin 1000 mg prolonged release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains:
Metformin hydrochloride 1000 mg corresponding to 780 mg metformin base
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release tablet .
Off-white coloured, oval, biconvex, film-coated tablets with score
line on one side and plain on
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary
management and exercise alone does not result in adequate glycemic
control. Metabet SR /
Bolamyn SR / Metformin may be used as monotherapy or in combination
with other oral
antidiabetic agents, or with insulin.
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 one tablet of Metabet SR / Bolamyn SR /
Metformin 500 mg tablet once
daily.
After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements. A
slow increase of dose may improve gastro-intestinal tolerability. The
maximum recommended
dose is 2 tablets of Metabet SR / Bolamyn SR / Metformin 1000 mg
tablet daily.
Dosage increases should be made in increments of 500 mg every 10-15
days, up to a maximum of
2000 mg once daily with the evening meal. If glycaemic control is not
achieved on 2000 mg of
Metabet SR / Bolamyn SR / Metformin once daily, 1000 mg of Metabet SR
/ Bolamyn SR /
Metformin twice daily should be considered, with both doses being
given with food. If glycaemic
control is still not achieved, patients may be switched to standard
metformin tablets to a
maximum dose of 3000 mg daily.
In patients already treated with metformin tablets, the starting dose
of Metabet SR / Bolamyn SR