Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Metformin hydrochloride
Teva UK Ltd
A10BA02
Metformin hydrochloride
500mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010202; GTIN: 5017007310624
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. METFORMIN 500MG & 850MG TABLETS PIL - UK Black BBBA0524 C.Grant 14/02/17 27.03.17 S.Anson 180 x 280 8pts Relonchem 14/02/17 + 21/02/17 02.03.17 6 _continued over page_ METFORMIN 500MG AND 850MG TABLETS Metformin hydrochloride _continued top of next column_ BBBA0524 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 or nurse. 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 METFORMIN TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE METFORMIN TABLETS 3 HOW TO TAKE METFORMIN TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE METFORMIN TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT METFORMIN TABLETS ARE AND WHAT THEY ARE USED FOR Metformin tablets contain 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 lead read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT METFORMIN 500mg TABLETS BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg Metformin Hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, circular, biconvex, film-coated tablets, impressed “MF” on one face. 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. • In adults, Metformin 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, Metformin may be used as monotherapy or in combination with insulin. A reduction of diabetic complications has been shown in overweight type 2 diabetic patients treated with metformin as first-line therapy after diet failure (see 5.1 Pharmacodynamic properties). 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 one tablet 2 or 3 times daily with or after food. 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 is 3g 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 _ _Adults: _Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin is given at the usual starting dose of one tablet 2-3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements._ _ _ _ _Elderly:_ Due to the potential for decreased renal function in elderly subjects, t read_full_document