Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Atenolol
Rowex Ltd
C07AB; C07AB03
Atenolol
100 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; atenolol
Marketed
1991-02-27
Package leaflet: Information for the user Atecor 25mg, 50mg & 100mg tablets atenolol What is in this leaflet: 1. What Atecor is and what it is used for 2. What you need to know before you take Atecor 3. How to take Atecor 4. Possible side effects 5. How to store Atecor 6. Contents of the pack and other information 1. What Atecor is and what it is used for Atecor contains a substance called atenolol. Atenolol belongs to a group of medicines called beta-blockers and is used for the treatment of: • high blood pressure (essential hypertension) • preventing chest pain (angina) • irregular or uneven heartbeats (cardiac arrhythmias) • protect the heart in early treatment after a heart attack (myocardial infarction) • long-term prophylaxis after recovery from a heart attack (to prevent another attack). This medicine works by making your heart beat more slowly and with less force. 2. What you need to know before you take Atecor Do not take Atecor if: • you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6) • you have heart failure which is not under control (this usually makes you breathless and causes your ankles to swell) • you suffer from other heart conditions: - second- or third-degree heart block (a condition which may be treated by a pacemaker) - bradycardia (very slow or uneven heartbeat) - low blood pressure (hypotension) - poor circulation (peripheral arterial disease) • you have a tumour called phaeochromocytoma that is not treated. This is usually near your kidney and can cause high blood pressure) • you have been told that you have higher than normal levels of acid in your blood (metabolic acidosis). You should first consult your doctor about these conditions. WARNINGS AND PRECAUTIONS: The initial treatment of severe high blood pressure should be very gradual so as to avoid a sudden drop of blood pressure. Talk to your doctor or pharmacist or nurse before taking Atecor if: • you have asthma, wheezing or any other similar breathing problems • Read the complete document
Health Products Regulatory Authority 17 September 2020 CRN009YFQ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atecor 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Atenolol 100 mg. Each tablet contains lactose monohydrate 4.32 mg and up to 15.2 mg sodium. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex, film-coated tablet with a one-sided score notch and embossed ‘100’ on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a beta-adrenoceptor blocker ATECOR is indicated for the treatment of: • essential hypertension • angina pectoris • cardiac arrhythmias. Atecor is also indicated in early intervention in the acute phase of myocardial infarction and for the long-term prophylaxis after recovery from myocardial infarction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION: Oral. Recommended dosage schedule: ADULTS: HYPERTENSION: The usual daily dose is 50 mg as a single dose. This can be increased to 100 mg daily if required for control but should only be done after the effects of the initial dose have been achieved (1 to 2 weeks). Atenolol may be combined with a diuretic if required or other antihypertensive agents. ANGINA: The usual daily dose is 100 mg given orally once daily or 50 mg given twice daily. CARDIAC ARRHYTHMIAS: For maintenance control the usual daily dose is 50 – 100 mg once daily. This can be increased to 100 mg daily if required for control but should only be done after the effects of the initial dose have been achieved (1 to 2 weeks). EARLY AND LATE INTERVENTION AFTER MYOCARDIAL INFARCTION: Oral treatment with atenolol can be initiated in haemodynamically stable patients with 50 mg twice daily and then100 mg once daily. During the early phase of acute myocardial infarction, treatment with atenolol should be initiated in Read the complete document