Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ATENOLOL
B & S Healthcare
ATENOLOL
50 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER TENORMIN ® 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is Tenormin 50mg Film-Coated Tablets but will be referred to as Tenormin throughout this leaflet. IN THIS LEAFLET: 1. What Tenormin is and what it is used for 2. Before you take Tenormin 3. How to take Tenormin 4. Possible side effects 5. How to store Tenormin 6. Further information 1. WHAT TENORMIN IS AND WHAT IT IS USED FOR Tenormin contains a medicine called atenolol. This belongs to a group of medicines called beta-blockers. Tenormin is used to: • Treat high blood pressure (hypertension). • Help prevent chest pain (angina). • Treat uneven heart beats (arrhythmias). • Protect the heart in the early treatment after a heart attack (myocardial infarction). • Help prevent another heart attack from happening. It works by making your heart beat more slowly and with less force. 2. BEFORE YOU TAKE TENORMIN DO NOT TAKE TENORMIN IF: • You are allergic (hypersensitive) to atenolol or any of the other ingredients in your medicine (see Section 6: Further information). • You have ever had any of the following heart problems: − heart failure which is not under control (this usually makes you breathless and causes your ankles to swell) − second- or third-degree heart block (a c Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tenormin 50mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg Atenolol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from the Greece:_ White, round, biconvex film-coated tablets, impressed Tenormin 50 on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Control of hypertension. Management of angina pectoris. Control of cardiac arrhythmias. Treatment of myocardial infarction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS CONTROL OF HYPERTENSION: Most patients respond to 50 mg daily given orally as a single dose. If necessary, the dose may be increased to 100 mg daily. The effect will be fully established after one to two weeks. A further reduction in blood pressure may be achieved by combining Tenormin with other antihypertensive agents. MANAGEMENT OF ANGINA PECTORIS: Most patients with angina pectoris will respond to 100 mg daily given orally as a single dose or as 50 mg given twice a day. It is unlikely that additional benefit will be gained by increasing the dose. CONTROL OF CARDIAC ARRHYTHMIAS: An oral maintenance dose of Tenormin is 50–100 mg, given once daily. EARLY AND LATE INTERVENTION AFTER MYOCARDIAL INFARCTION: Oral treatment with Tenormin can be initiated in haemodynamically stable patients with 50 mg twice daily and then 100 mg once daily. During the early phase of acute myocardial infarction, treatment with Tenormin should be initiated in hospital under close monitoring. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, Tenormin should be discontinued. Tenormin 100 mg daily is recommended for long-term prophylaxis of myocardial infarction. CHIL Read the complete document