Metnova 1000 mg, filmomhulde tabletten

Land: Niederlande

Sprache: Niederländisch

Quelle: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Wirkstoff:

METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE

Verfügbar ab:

Mylan Ireland Limited 35/36 Grange Parade, Baldoyle Industrial Estate DUBLIN 13 (IERLAND)

ATC-Code:

A10BA02

INN (Internationale Bezeichnung):

METFORMINEHYDROCHLORIDE COMPOSITION corresponding to ; METFORMIN

Darreichungsform:

Filmomhulde tablet

Zusammensetzung:

HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MACROGOL 400 ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201),

Verabreichungsweg:

Oraal gebruik

Therapiebereich:

Metformin

Produktbesonderheiten:

Hulpstoffen: HYPROLOSE (E 463); HYPROMELLOSE (E 464); MACROGOL 400; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201);

Berechtigungsdatum:

2010-01-13

Gebrauchsinformation

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METNOVA 500 MG, FILMOMHULDE TABLETTEN
METNOVA 850 MG, FILMOMHULDE TABLETTEN
METNOVA 1000 MG, FILMOMHULDE TABLETTEN
metformin hydrochloride
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 Metnova is and what it is used for.
2.
What you need to know before you take Metnova.
3.
How to take Metnova.
4.
Possible side effects.
5.
How to store Metnova.
6.
Contents of the pack and other information.
1. WHAT METNOVA IS AND WHAT IT IS USED FOR
WHAT METNOVA IS
Metnova
contains the active substance metformin hydrochoride
,
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. Metnova
helps to
lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Metnova
over a long period of time also helps to lower the risk
of complications associated with diabetes.
Metnova is associated with either a stable body weight or modest
weight loss.
WHAT METNOVA IS USED FOR
Metnovae 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
bl

Fachinformation

PAGE 1 OF 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metnova 500 mg, filmomhulde tabletten
Metnova 850 mg, filmomhulde tabletten
Metnova 1000 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 500 mg film-coated tablet contains 500 mg metformin hydrochloride
equivalent to metformin base
390 mg.
Each 850 mg film-coated tablet contains 850 mg metformin hydrochloride
equivalent to metformin base
662.9 mg.
Each 1000 mg film-coated tablet contains 1000 mg metformin
hydrochloride equivalent to metformin
base 780 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
500 mg: White, round, normal convex, film-coated tablets plain on both
sides. Diameter about
12.0 mm.
850 mg: White, round, normal convex, film-coated tablets plain on both
sides. Diameter about
13.5 mm.
1000 mg: White, oval, film coated tablet, debossed “MF” and
“3” on either side of the breakline on one
side and “G” on the other side. The tablet can be divided into
equal halves.
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, Metnova film-coated tablets may be used as monotherapy
or in combination with other oral
anti-diabetic agents or with insulin.
• In children from 10 years of age and adolescents, Metnova
film-coated tablets 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
PAGE 2 OF 10
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 500 mg or 850 mg
metformin 2 or 3 times daily given during
or after meals.
Af