Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
METFORMIN HYDROCHLORIDE
Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
A10BA02
METFORMIN HYDROCHLORIDE 500 mg
PROLONGED-RELEASE TABLET
METFORMIN HYDROCHLORIDE 500 mg
POM
DRUGS USED IN DIABETES
Withdrawn
2008-04-14
Helvetica/ITC Zapf Dingbats (job box) Univers 7pt text size Supplier Instructions Artwork text and content must not be reset, remade, amended or altered. The only exceptions to this are: ❖ bleeds, chokes, spreads or other adjustments required for print reproduction purposes only. If you have any difficulties please contact the Teva Artwork Team. We must receive a copy of the 3rd Party Vendors Proof before final approval can be made. SENIOR ARTWORK CO-ORDINATOR Signature Date / / SUBJECT TO REG. AGENCY APPROVAL ❏ Signed APPROVED BY REG. DEPT. FOR PRINT ❏ Date --- Adobe Illustrator CS CUTTERGUIDE (not for Print) BLACK PMS GREEN 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: Last Colour Sep Date: --- 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 Citiți documentul complet
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 Citiți documentul complet