Metformin Denk 500 tablets film-coated

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

metformin (metformin hydrochloride)

Tilgængelig fra:

Denk Pharma GmbH & Co. KG

ATC-kode:

A10BA02

INN (International Name):

metformin (metformin hydrochloride)

Dosering:

500mg

Lægemiddelform:

tablets film-coated

Enheder i pakken:

(30/3x10/) in blister, (100/10x10/) in blister

Recept type:

Prescription

Autorisation status:

Registered

Autorisation dato:

2021-10-08

Indlægsseddel

_Metformin Denk 500_
Film-coated tablet – oral use
Oral anti-diabetic agent
Active substance: metformin
Package leaflet:
Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPOR-
TANT 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 METFORMIN DENK 500 IS
AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE METFORMIN DENK 500
3.
HOW TO TAKE METFORMIN DENK 500
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE METFORMIN DENK 500
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Metformin Denk 500 is and what
it is used for
Metformin Denk 500 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 Denk 500 helps
to lower your blood glucose to as normal levels as
possible.
If you are an overweight adult, taking Metformin
Denk 500 over a long period of time also helps to lower
the risk of complications associated with diabetes.
Metformin Denk 500 is associated with either a stable
body weight or modest weight loss.
Metformin Denk 500 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 glucos

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metformin Denk 500
Metformin Denk 850
Metformin Denk 1000
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: metformin
_Metformin Denk 500 _
Each film-coated tablet contains 500 mg metformin hydrochloride
equivalent to 390 mg
metformin.
Excipient with known effect: Each film-coated tablet contains 7.04 mg
of lactose monohydrate.
_Metformin Denk 850 _
Each film-coated tablet contains 850 mg metformin hydrochloride
equivalent to 662.8 mg
metformin.
_Metformin Denk 1000 _
Each film-coated tablet contains 1,000 mg metformin hydrochloride
equivalent to 780 mg
metformin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_Metformin Denk 500 _
White, round, biconvex film-coated tablets, without facet.
_Metformin Denk 850 _
White, oblong film-coated tablets, with a deep snap-tab break mark on
one side and break mark on the
other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
_Metformin Denk 1000 _
White, oblong film-coated tablets with a deep snap-tab break mark on
one side and break mark on the
other side.
The film-coated tablets can be divided into equal doses.
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.
2
-
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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults with normal renal function (GFR ≥ 90 mL/min)
_Monotherapy and combination with other