Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
ATENOLOL
Mercury Pharmaceuticals (Ireland) Ltd
C07AB03
ATENOLOL
50 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective
Authorised
1990-03-22
PACKAGE LEAFLET: INFORMATION FOR THE USER ATENOGEN® 50MG FILM-COATED TABLETS ATENOLOL 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Atenogen Film-coated Tablets are and what they are used for 2. Before you are take Atenogen Film-coated Tablets 3. How to take Atenogen Film-coated Tablets 4. Possible side effects 5. How to store Atenogen Film-coated Tablets 6. Further information 1. WHAT ATENOGEN FILM-COATED TABLETS ARE AND WHAT THEY ARE 1. WHAT ATENOGEN FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Atenogen Film Coated Tablets belong to a group of medicines called beta-blockers.and may be used to treat hypertension (high blood pressure) or to treat angina (a type of chest pain). They may also be used to treat irregular heartbeats and to protect the heart following a heart attack. 2. BEFORE YOU ARE TAKE ATENOGEN FILM-COATED TABLETS 2. BEFORE YOU ARE TAKE ATENOGEN FILM-COATED TABLETS DO NOT TAKE ATENOGEN FILM-COATED TABLETS • if you are allergic (hypersensitive) to atenolol or any of the other ingredients of Atenogen Film- coated Tablets (listed in section 6) • if you have low blood pressure • if you have been told that you have a heart block • if you suffer from a tight, painful feeling in the chest at the time of rest (Prinzmetal’s angina) or other heart problems • if you have been told that you have very slow or irregular heart beat • if you have difficulty in breathing, tiredness or ankle swelling due to heart disease • if you suffer from a chest problem su Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atenogen 50 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg Atenolol. Excipients - Contains Lactose Monohydrate 28.0mg For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet. White, round, film-coated tablets marked “AT/50” on one face and the company logo on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1) Management of essential hypertension 2) Management of angina pectoris 3) Management of cardiac dysrhythmias 4) Long-term prophylaxis after recovery from acute myocardial infarction 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Atenogen film coated Tablets are for oral administration. _Adults:_ _Hypertension: _50mg daily as a single dose (higher doses rarely necessary). The full effects of atenolol, which will be established after one or two weeks, should be achieved before determining the need to increase the dosage from 50 to 100 mg daily. Atenolol may be combined with a diuretic or other antihypertensive agent to achieve further reduction in blood pressure. _Angina pectoris: _The usual dose is 100mg daily, taken as a single dose or as 50mg twice daily. _Dysrhythmias: _The usual maintenance dose is 50 - 100mg daily. _Myocardial infarction: _The usual dose is 100mg daily for long-term prophylaxis, where beta-blockade is appropriate for patients presenting later after infarction. _Elderly:_ Dosage may need to be reduced, especially in patients with impaired renal function. _Children:_ As there is no paediatric experience with atenolol, it is not recommended for use in children. HEALTH PRODUCTS REGULATORY AUTHORITY _____________________________________________________________________________________________________________________ Lestu allt skjalið