Metformine Laurus 500 mg, filmomhulde tabletten

Land: Nederländerna

Språk: nederländska

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

Aktiva substanser:

METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE

Tillgänglig från:

Laurus Generics GmbH Van-der-Smissen-Strasse 1 22767 HAMBURG (DUITSLAND)

ATC-kod:

A10BA02

INN (International namn):

METFORMINEHYDROCHLORIDE COMPOSITION corresponding to ; METFORMIN

Läkemedelsform:

Filmomhulde tablet

Sammansättning:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)

Administreringssätt:

Oraal gebruik

Terapiområde:

Metformin

Tillstånd datum:

2019-06-26

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METFORMINE LAURUS 500 MG, FILMOMHULDE TABLETTEN
METFORMINE LAURUS 1000 MG, FILMOMHULDE TABLETTEN
Metformin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKINGTHIS
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
film-coated tablets contain 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.
helps to lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking over a long
period of time also helps to lower
the risk of complications associated with diabetes. is
associated with either a stable
body weight or modest weight loss.
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.

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metformine Laurus 500 mg, filmomhulde tabletten
Metformine Laurus 1000 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
500 mg film-coated tablets
One film-coated tablet contains 500 mg metformin hydrochloride
corresponding to 390 mg
metformin base.
The dimension of the film-coated tablet is 11.0 mm to 11.40 mm.
1000 mg film-coated tablets
One film-coated tablet contains 1000 mg metformin hydrochloride
corresponding to 780 mg
metformin base.
The dimension of the film-coated tablet is 19.0 -19.4 mm x 10.5 - 10.9
mm.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
500 mg film-coated tablets
White to off white, round, biconvex, film-coated tablets with
‘LA15” debossed on one side and plain
on the other side.
1000 mg film-coated tablets
White to off white, oval, biconvex, film-coated tablets, bisected on
both sides, with ‘LA’ and ‘07’
debossed on either side of bisect line on one side. The tablet 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.

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).
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR _
_ 90 mL/min) _
_ _
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS
The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2
or 3