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:

500mg

Pharmaceutical form:

tablets prolonged-release

Prescription type:

Prescription

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Metabet SR 500 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 500mg 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 speciall

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metabet SR 500mg prolonged release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains:
Metformin hydrochloride 500 mg corresponding to 390 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 plain on both
sides.
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 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 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 4 tablets of Metabet SR 500 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 once daily, of 1000 mg of Metabet SR
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
should be equivalent to the daily dose of metformin immediate release
tablets. In
patients
treated
with
metformin
at
a
dose
above
2000
mg
daily,
switching
to
Metformin prolonged release tablets is not recommended.
If transfer from another oral antidiabetic ag