Metfogamma

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Tabia za bidhaa Tabia za bidhaa (SPC)
14-10-2013

Viambatanisho vya kazi:

metformin (metformin hydrochloride)

Inapatikana kutoka:

Artesan Pharma GmbH & Co. KG

INN (Jina la Kimataifa):

metformin (metformin hydrochloride)

Kipimo:

850mg

Dawa fomu:

tablets film-coated

Dawa ya aina:

Prescription

Tabia za bidhaa

                                ___________________________________________________________________________
Enclosure
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
METFO_gamma_
®
850
Active ingredient: metformin hydrochloride, film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Each film-coated tablet contains 850 mg of metformin hydrochloride,
corresponding to 663 mg of metformin.
For a complete list of other constituents please see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Therapy of type 2 diabetes mellitus; particularly in overweight
patients in whom diet and
physical activity alone are not able to achieve sufficient adjustment
of blood sugar lev-
els.
-
In adults METFO_gamma_
®
850 can be administered in the form of a monother-
apy or in combination with other oral antidiabetics or insulin.
-
In children aged 10 and up and adolescents METFO_gamma_
®
850 can be ad-
ministered in the form of a monotherapy or in combination with
insulin.
Page: 1 of 12
In overweight adult patients with type 2 diabetes mellitus it has been
possible to show that
after the failure of dietary measures metformin hydrochloride is the
therapy of first choice
for reducing the frequency of diabetes-induced complications (see 5.1
"Pharmacodynamic
Properties").
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _
_Monotherapy and Combination with Other Oral Antidiabetics _
-
In general the initial dose consists of the administration of 1
film-coated tablet con-
taining 500 mg or 850 mg of metformin hydrochloride two or three times
a day dur-
ing or after meals. After 10 to 15 days the dosage should be adapted
in accor-
dance with measurements of the blood sugar levels. A slow increase in
dosage
has a positive effect on the gastrointestinal tolerance of the
medication.
The maximum recommended dose is 3 g of metformin hydrochloride a day.
-
In the event of a changeover from a different oral antidiabetic to
metformin hydro-
chloride the medication taken
                                
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