البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Atenolol
Clonmel Healthcare Ltd
C07AB; C07AB03
Atenolol
25 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; atenolol
Marketed
1988-07-25
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ATENOMEL 25MG TABLETS ATENOMEL 50MG TABLETS ATENOMEL 100MG TABLETS ATENOLOL 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Atenomel Tablets are and what they are used for 2. What you need to know before you take Atenomel Tablets 3. How to take Atenomel Tablets 4. Possible side effects 5. How to store Atenomel Tablets 6. Contents of the pack and other information 1. WHAT ATENOMEL TABLETS ARE AND WHAT THEY ARE USED FOR Atenomel Tablets contain the active substance atenolol. Atenolol belongs to a group of medicines called beta-blockers. These medicines control the heart rate and blood pressure by making your heart beat more slowly and with less force. Atenomel is used to: Control high blood pressure (hypertension) Help prevent chest pain (angina) Treat uneven heart beats (arrhythmias) Protect the heart in early treatment after a heart attack (myocardial infarction) Help prevent another heart attack from happening. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATENOMEL TABLETS DO NOT TAKE ATENOMEL TABLETS - if you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6). - if you have ever had any of the following heart disorders: - 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 condition which may be treated with a pacemaker) - very slow or irregular heart-beat, very low blood pre اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atenomel 25 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tablet contains 25mg atenolol Excipients with known effect: Each tablet contains lactose monohydrate 15.5mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, biplanar tablets marked “C 23”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A beta-adrenoceptor blocker for the treatment of essential hypertension. Management of angina pectoris. Control of cardiac arrhythmias. In early intervention in the acute phase of myocardial infarction and for long-term prophylaxis after recovery from 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 Atenomel 25 mg 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 atenolol is 50 – 100 mg, given once daily. Early and late intervention after myocardial infarction: Oral treatment with atenolol 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 atenolol should be initiated in hospital under close monitoring. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued. Atenolol 100 mg daily is recommended for long-term prophylaxis of myocardial infarction. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ اقرأ الوثيقة كاملة