Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Metoprolol tartrate
Actavis UK Ltd
C07AB02
Metoprolol tartrate
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5012617009814 5012617015488
Actavis BST - Packing Technical BSTCutterGuideReq@actavis.com Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Metoprolol Tartrate 50 & 100mg x 28 & 56’s (UK) 148x210 (Reel Fed) 50907225 Leaflet for Blisters 4266 R.Wrey 08/08/16 148x210 Leaflet Reel Fed Profile (BST) * 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. METOPROLOL TARTRATE 50MG AND 100MG TABLETS PIL - UK Black Profile BBBA0028 C.Grant 21/09/16 01.12.16 S.Anson 148 x 210 7pts Actavis UK N/A N/A 05 METOPROLOL TARTRATE 50MG AND 100MG TABLETS _Continued over page_ 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 METOPROLOL TARTRATE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE METOPROLOL TARTRATE TABLETS 3 HOW TO TAKE METOPROLOL TARTRATE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE METOPROLOL TARTRATE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT METOPROLOL TARTRATE TABLETS ARE AND WHAT THEY ARE USED FOR Metoprolol Tartrate belongs to a group of medicines called beta-blockers. It is used to TREAT: • high blood pressure • an Read the complete document
1 NAME OF THE MEDICINAL PRODUCT METOPROLOL TARTRATE TABLETS BP 100mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg Metoprolol Tartrate. Excipient with known effect: Each tablet contains 48.40mg of lactose monohydrate PhEur. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White to off-white, uncoated tablets. White to off-white, circular, biconvex uncoated tablets impressed “50” and the identifying letters “MJ” on either side of a central division line on one face, plain on the reverse. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4.1 THERAPEUTIC INDICATIONS In the management of: 1) Hypertension. 2) Angina pectoris. 3) Cardiac arrhythmias (especially supraventricular tachyarrhythmias). 4) As an adjunctive treatment of thyrotoxicosis. 5) Prophylaxis of migraine. 6) Early intervention of metoprolol tartrate in acute myocardial infarction reduces infarct size and the incidence of ventricular fibrillation. Pain relief may also decrease the need for opiate analgesics. Metoprolol tartrate has been shown to reduce mortality when administered to patients with acute myocardial infarction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The following dosage regimes are intended only as a guideline and should always be adjusted to the individual requirements of the patient. _Adults _ _Hypertension_ Initially 100mg daily. This may be increased, if necessary, to 200mg daily in single or divided doses. Combination therapy with a diuretic or vasodilator may also be considered to further reduce blood pressure. Metoprolol may be administered with benefit both to previously untreated patients with hypertension and to those in whom the response to previous therapy is inadequate. In the latter type of patient the previous therapy may be continued and metoprolol added in to the regime with adjustment of the previous therapy if necessary. _Angina_ Usually 50-100mg two or three times daily. In general a significant impro Read the complete document