Metformin tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

metformin (metformin hydrochloride)

Available from:

REPLEK FARM Ltd. Skopje

ATC code:

A10BA02

INN (International Name):

metformin (metformin hydrochloride)

Dosage:

500mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-07-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
METFORMIN
(Metformin)
500 MG FILM COATED TABLETS
850 MG FILM COATED TABLETS
1000 MG FILM COATED TABLETS
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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 any of the side effects become serious or troublesome, or if you
notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Metformin is and what it is used for
2.
Before you take Metformin
3.
How to take Metformin
4.
Possible side effects
5.
How to store Metformin
6.
Further information
1. WHAT METFORMIN IS AND WHAT IT IS USED FOR
WHAT METFORMIN IS
Metformin 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.
Metformin helps to lower your blood glucose to as normal a level as
possible. If you are an
overweight adult, taking Metformin over a long period of time also
helps to lower the risk of
complications associated with diabetes. Metformin is associated with
either a stable body
weight or modest weight loss.
WHAT METFORMIN IS USED FOR
Metformin 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 Metformin on its own or together with other medicines
to treat diabetes
(m

Summary of Product characteristics

- 1 -
- 1 -
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
METFORMIN
(Metformin)
500 MG FILM COATED TABLETS
850 MG FILM COATED TABLETS
1000 MG FILM COATED TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 500 mg metformin hydrochloride.
Each film coated tablet contains 850 mg metformin hydrochloride.
Each film coated tablet contains 1000 mg metformin hydrochloride.
* For full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablet.
METFORMIN 500 mg film coated tablets are uniform, round, white,
biconvex film coated
tablets.
METFORMIN 850 mg film coated tablets are uniform, oblong, biconvex,
white film coated
tablets.
METFORMIN 1000 mg film coated tablets are oval, biconvex, oblong
(caplet type), white
film coated tablets, with break lines on both sides and a facet.
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, Metformin may be used as monotherapy or in combination with
other oral
antidiabetic agents or with insulin.

In children from 10 years of age and adolescents, Metformin 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).
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- 2 -
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
_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 i