GLUCOPHAGE 500 Milligram Film Coated Tablet

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

METFORMIN HYDROCHLORIDE

から入手可能:

Merck Serono Limited

ATCコード:

A10BA02

INN（国際名）:

METFORMIN HYDROCHLORIDE

投薬量:

500 Milligram

医薬品形態:

Film Coated Tablet

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

Biguanides

認証ステータス:

Authorised

承認日:

2010-06-04

情報リーフレット

MC-2076-2016
WHAT IS IN THIS LEAFLET
1.
What Glucophage is and what it is used for
2.
What you need to know before you take Glucophage
3.
How to take Glucophage
4.
Possible side effects
5.
How to store Glucophage
6.
Contents of the pack and other information
1. WHAT GLUCOPHAGE IS AND WHAT IT IS USED FOR
Glucophage 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. Glucophage helps to lower
your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Glucophage over a long period
of time also helps to lower the risk of complications associated with
diabetes. Glucophage is associated with either a stable body weight
or modest weight loss.
Glucophage 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 Glucophage on its own or together with other medicines
to treat diabetes (medicines taken by mouth or insulin).
Children 10 years and over and adolescents can take Glucophage on
its own or together with insulin.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLUCOPHAGE
DO NOT TAKE GLUCOPHAGE
• if you are allergic (hypersensitive) to metformin or any of the
other
ingredients of this medicine (see ‘What Glucophage contains’ in
section 6)
• if you have liver problems
• if you have severely reduced kidney function
• if
you
have
uncontrolled
diabetes,
with,
for
example,
severe
hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea,
rapid weight loss, lactic acidosis (see “Ris

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucophage 500 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 500 mg metformin hydrochloride
corresponding to 390 mg metformin base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, circular, convex film-coated tablets, 11 mm in diameter and 5.7
mm high, engraved with GL 500.
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, Glucophage 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, Glucophage 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.
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 starting dose of 500 mg or 850 mg
2 or 3 times daily, while insulin dosage is
adjusted on the basis of blood glu