Metformin Crescent 500 mg Tablets

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

METFORMIN HYDROCHLORIDE

Pieejams no:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATĶ kods:

A10BA02

SNN (starptautisko nepatentēto nosaukumu):

METFORMIN HYDROCHLORIDE 500 mg

Zāļu forma:

FILM-COATED TABLET

Kompozīcija:

METFORMIN HYDROCHLORIDE 500 mg

Receptes veids:

POM

Ārstniecības joma:

DRUGS USED IN DIABETES

Produktu pārskats:

Licence number in the source country: NOT APPLICAPABLE

Autorizācija statuss:

Authorised

Autorizācija datums:

2020-05-14

Lietošanas instrukcija

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PACKAGE LEAFLET: INFORMATION FOR THE USER
METFORMIN CRESCENT 500 MG TABLETS
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.
­
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 have any further questions, ask your doctor or pharmacist.
­
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Metformin is and what it is used for
2.
What you need to know before you take Metformin
3.
How to take Metformin
4.
Possible side effects
5.
How to store Metformin
6.
Contents of the pack and other information
1. WHAT METFORMIN IS AND WHAT IT IS USED FOR
Metformin belongs to a group of medicines called oral hypoglycaemics.
It works by reducing the level
of sugar in the blood.
Metformin Tablets are used for the treatment of Type 2 diabetes in
patients when diet and exercise
have not been enough to keep their blood sugar level under control,
especially when these patients are
overweight.
The tablets can be used as follows:
ADULTS
(18 or over):
•
as the only medicine for the treatment of diabetes
•
with other anti­diabetic medicines also taken by mouth
•
in combination with insulin.
CHILDREN
(10 to 17):
•
as the only medicine for the treatment of diabetes
•
in combination with insulin.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METFORMIN
Tests should have been done, especially if you are elderly (65 or
over) to assess the risks and benefits
of you taking this medicine and to check the functioning of your
kidneys.
DO NOT TAKE THESE TABLETS:
•
If you are allergic to the active substance metformin hydrochloride or
to any of the other
ingredients in this medicine (these are listed in section 6)
•
If you have failed to re

Produkta apraksts

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metformin Crescent 500 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains metformin hydrochloride 500 mg
For excipients see 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablets
White coloured, round shaped, biconvex tablets engraved with “C”
on one side and “323” on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-insulin-dependent diabetes (NIDDM, type II) and, in particular, in
overweight patients,
when adequate dietary treatment and exercise has failed.
In adults metformin hydrochloride 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
hydrochloride 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
DOSAGE
Usual dosage:
ADULTS WITH NORMAL RENAL FUNCTION (GFR ≥ 90ML/MIN):
_Monotherapy and combination with other oral antidiabetics _
Therapy should be initiated with one 850mg tablet twice a day or one
500mg tablet three
times a day. In order to minimise the gastro-intestinal side-effects
the daily dose should be
divided and taken with or after meals. Diabetic control may be
achieved within a few days but
the full effect can be delayed for up to 2 weeks.
If diabetic control is incomplete a cautious increase in dosage to a
maximum of 3g daily taken
as 3 divided doses is justified. Once control has been achieved it may
be possible to reduce
the daily dose.
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After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements.
A slow increase of dose may improve gastrointestinal tolerability.
Once adequate control has
been achieved a reduction in dosage may be possible. If transfer from
another oral
antidiabetic agent is