Metophage 500 mg Film-Coated Tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ixtrih issa

Ingredjent attiv:

METFORMIN HYDROCHLORIDE

Disponibbli minn:

Rowex Ltd

Kodiċi ATC:

A10BA; A10BA02

INN (Isem Internazzjonali):

METFORMIN HYDROCHLORIDE

Dożaġġ:

500 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Biguanides; metformin

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2008-12-19

Fuljett ta 'informazzjoni

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METOPHAGE 500 MG FILM-COATED TABLETS
METOPHAGE 850 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
Metophage is and what it is used for
2. What you need to know before you take Metophage
3. How to take Metophage
4. Possible side effects
5.
How to store Metophage
6. Contents of the pack and other information
1.
WHAT METOPHAGE IS AND WHAT IT IS USED FOR
Metophage 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. Metophage helps
to lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Metophage over a long period of
time also helps to lower the
risk of complications associated with diabetes. Metophage is
associated with either a stable body
weight or modest weight loss.
Metophage 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. It is used
particularly in overweight patients.
ADULTS
can take Metophage on its own or together wit
                                
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Karatteristiċi tal-prodott

                                Health Products Regulatory Authority
20 August 2021
CRN00CJP8
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metophage 500 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg metformin hydrochloride
equivalent to 390 mg metformin base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, white, double radius film-coated tablet, embossed “M 500”
on one side and plain on the reverse 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, Metophage 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, Metophage 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. 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.
_Renal impairment_
A GFR should be assessed before initiation of treatment with metformin
containing products and at least annually thereafter. In
patients at an increased risk of further pr
                                
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