Metformin Denk 850 tablets film-coated

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

metformin (metformin hydrochloride)

Διαθέσιμο από:

Denk Pharma GmbH & Co. KG

Φαρμακολογική κατηγορία (ATC):

A10BA02

INN (Διεθνής Όνομα):

metformin (metformin hydrochloride)

Δοσολογία:

850mg

Φαρμακοτεχνική μορφή:

tablets film-coated

Μονάδες σε πακέτο:

(30/2x15/) in blister

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2016-12-05

Φύλλο οδηγιών χρήσης

_Metformin Denk 850_
Film-coated tablet – Oral use
Oral anti-diabetic agent
Active substance: metformin
Package leaflet:
Information for the user
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CON-
TAINS 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 doc-
tor or pharmacist. This includes any pos-
sible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. WHAT METFORMIN DENK 850 IS AND WHAT IT
IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
METFORMIN DENK 850
3. HOW TO TAKE METFORMIN DENK 850
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE METFORMIN DENK 850
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1
. What Metformin Denk 850 is and
what it is used for
Metformin Denk 850 contains metformin, a med-
icine to treat diabetes. It belongs to a group of
medicines called biguanides.
Insulin is a hormone produced by the pancre-
as that makes your body take in glucose (sugar)
from the blood. Your body uses glucose to pro-
duce 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 850 helps to lower your blood glucose to
as normal levels as possible.
If you are an overweight adult, taking Metform-
in Denk 850 over a long period of time also helps
to lower the risk of complications associated
with diabetes. Metformin Denk 850 is associ-
ated with either a stable body weight or mod-
est weight loss.
Metformin Denk 850 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 you

Αρχείο Π.Χ.Π.

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 1000 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 OTH