Glyformin 500mg film-coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

METFORMIN HYDROCHLORIDE

Tilgængelig fra:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC-kode:

A10BA02

INN (International Name):

METFORMIN HYDROCHLORIDE 500 mg

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

METFORMIN HYDROCHLORIDE 500 mg

Recept type:

POM

Terapeutisk område:

DRUGS USED IN DIABETES

Autorisation status:

Authorised

Autorisation dato:

2007-02-15

Indlægsseddel

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GLYFORMIN 500 MG FILM-COATED 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.
−
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 Glyformin is and what it is used for
2.
What you need to know before you take Glyformin
3.
How to take Glyformin
4.
Possible side effects
5.
How to store Glyformin
6.
Contents of the pack and other information
1.
WHAT GLYFORMIN IS AND WHAT IT IS USED FOR
Glyformin contains 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.
Glyformin helps to lower your blood glucose to as normal a level as
possible.
If you are an overweight adult, taking Glyformin over a long period of
time also helps to lower
the risk of complications associated with diabetes. Glyformin is
associated with either a stable
body weight or modest weight loss.
Glyformin is used to treat patients with type 2 diabetes (also called
‘non-insulin dependent
siabetes’) when diet and exercise alone have not been enough to
control your blood glucose
levels. It is used particularly in overweight patients.
Adults can take Glyformin on its

Produktets egenskaber

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glyformin 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
Film-coated tablet.
White to off white, round, biconvex film-coated tablets, embossed with
“MET 500” on one
side and plain on the other side.
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, Glyformin 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, Glyformin 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 OTHER ORAL ANTIDIABETIC AGENTS
The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2
or 3 times daily given
during or after meals.
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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.
The maximum recommended dose of metformin hydrochloride is 3 g daily,
taken as 3 divided
doses.
If transfer from another oral antidiabetic agent is intended:
discontinue the other agent and
initiate metformin at the dose indicated above.
COMBINATION WITH INSULIN
Metformin and insulin may be used in combination therapy to achieve
better blood glucose
control. Metformin hydrochloride is given at the usual startin