Metformin Teva 500mg SR Tablets

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

METFORMIN HYDROCHLORIDE

Доступна з:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

Код атс:

A10BA02

ІПН (Міжнародна Ім'я):

METFORMIN HYDROCHLORIDE 500 mg

Фармацевтична форма:

PROLONGED-RELEASE TABLET

Склад:

METFORMIN HYDROCHLORIDE 500 mg

Тип рецепту:

POM

Терапевтична области:

DRUGS USED IN DIABETES

Статус Авторизація:

Withdrawn

Дата Авторизація:

2008-04-14

інформаційний буклет

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PRODUCT: METFORMIN 500MG PR TABLETS ALL TUK
JOB N
O
: 10808
DATE: 12-6-07 
SAP N
O
: N/A 
DESIGNER: WA 
DRAFT: 6
PHARMACODE X
TEMPLATE: N/A
REV DATE: 28-1-08
REVISER: WA
PAGE: 1 OF 2
Strength: 500MG
Livery: TUK
BarCode: N/A
Dimensions: 160 X 280MM
Component: LEAFLET
Artworker’s Signature:
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Other information: X
METFORMIN 500 MG PR TABLETS
METFORMIN HYDROCHLORIDE

PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 
THIS MEDICINE.
•  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. Do not 
pass it on to others. It may harm them, even if their 
symptoms are the same as yours.
•  If any of the side effects get serious, or if you notice 
any side effects not listed in this leaflet, please tell 
your doctor or pharmacist.
IN THIS LEAFLET:
1. WHAT METFORMIN PR TABLETS IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE METFORMIN PR TABLETS
3. HOW TO TAKE METFORMIN PR TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE METFORMIN PR TABLETS
6. FURTHER INFORMATION

Характеристики продукта

Page 1 of 7 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Metformin Teva 500 mg SR Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One prolonged-release tablet contains 500 mg metformin hydrochloride
equivalent to 390 mg 
metformin. 

For a full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 

Prolonged-release tablet  

White to off white, oval shaped tablet, debossed "93" on one side
and "7267" on the other side. 

4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 

Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary 
management and exercise alone does not result in adequate glycaemic
control. Metformin PR may be 
used as monotherapy or in combination with other oral
antidiabetic agents, or with insulin. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
_ _
_Monotherapy and combination with other oral antidiabetic agents:_ 
•   The usual starting dose is one tablet once daily.  
•   After 10 to 15 days the dose should be adjusted on the
basis of blood glucose measurements. A 
slow increase of dose may improve gastro-intestinal tolerability.
The maximum recommended 
dose is 4 tablets daily.  
•   Dosage increases should be made in increments of 500
mg every 10-15 days, up to a maximum of 
2000 mg once daily with the evening meal. If glycaemic control is
not achieved on  2000 mg of 
Metformin PR once daily, 1000 mg of Metformin PR twice
daily should be considered, with both 
doses being given with food. If glycaemic control is still not
achieved, patients may be switched 
to standard metformin tablets to a maximum dose of 3000 mg daily.

•   In patients already treated with metformin tablets, the
starting dose of Metformin PR should be 
equivalent to the daily dose of metformin immediate-release
tablets. In patients treated with 
metformin at a dose above 2000 mg daily, swit