Country: Malta
Language: English
Source: Medicines Authority
PROPRANOLOL HYDROCHLORIDE
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
C07AA05
PROPRANOLOL HYDROCHLORIDE 80 mg
FILM-COATED TABLET
PROPRANOLOL HYDROCHLORIDE 80 mg
POM
BETA BLOCKING AGENTS
Withdrawn
2012-12-12
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER PROPRANOLOL 10 MG FILM-COATED TABLETS PROPRANOLOL 40 MG FILM-COATED TABLETS PROPRANOLOL 80 MG FILM-COATED TABLETS PROPRANOLOL HYDROCHLORIDE 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 or nurse. • 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 of the side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Propranolol is and what it is used for 2. What you need to know before you take Propranolol 3. How to take Propranolol 4. Possible side effects 5. How to store Propranolol 6. Contents of the pack and other information 1. WHAT PROPRANOLOL IS AND WHAT IT IS USED FOR Propranolol contains propranolol hydrochloride which belongs to a group of medicines called beta- blockers. It has effects on the heart and circulation and also on other parts of the body. Propranolol can be used for:Hypertension (high blood pressure) • Angina (chest pain) • Some arrythmias (disorders of heart rhythm) • Protection of the heart after a myocardial infarction (heart attack) • Migraine • Essential tremor (involuntary and rhythmic shaking) • Certain thyroid conditions (thyrotoxicosis and hyperthyroidism, which are caused by an overactive thyroid gland) • Hypertrophic cardiomyopathy (thickened heart muscle) • Phaeochromocytoma (high blood pressure due to a tumour usually near the kidney) • Bleeding in the oesophagus caused by high blood pressure in the liver. Page 2 of 8 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPRANOLOL DO NOT TAKE PROPRANOLOL TABLETS IF YOU: • are allergic (hypersensitive) to propranolol hydrochloride or any of t Read the complete document
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Propranolol 80 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Propranolol hydrochloride 80 mg, film coated tablet Each tablet contains 80 mg propranolol hydrochloride. Also contains 267.20 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet 80 mg: White to off-white round, biconvex film-coated tablets imprinted with "AM" on one side and a score line on the other side. NOTE: Diameter of the tablet 11.5 mm 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 • Angina pectoris. • Hypertension. • Long-term prophylaxis against myocardial reinfarction after recovery from acute myocardial infarction • Hypertrophic obstructive cardiomyopathy. • Essential tremor. • Supraventricular cardiac arrhythmia. • Ventricular cardiac arrythmias. • Hyperthyroidism and thyrotoxicosis • Phaeochromocytoma (with an alpha-blocker). • Migraine. • Prophylaxis of upper gastrointestinal bleeding in patients with portal hypertension and oesophageal varices. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: HYPERTENSION Page 2 of 11 A starting dose of 80 mg twice a day may be increased at weekly intervals according to response. The usual dose range is 160 to 320 mg per day. With concurrent diuretic or other antihypertensive drugs a further reduction of blood pressure is obtained. ANGINA, MIGRAINE AND ESSENTIAL TREMOR: The starting dose is 40 mg two to three times daily, increasing by the same amount at weekly intervals according to the patient response. An adequate response in migraine and essential tremor is usually seen in the range 80 to 160 mg/day and in angina in the range 120 to 240 mg/day. ARRHYTHMIAS, TACHYCARDIA, HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY AND THYROTOXICOSIS A dosage range of 10 to 40 mg three or four times a day usually achieves the require Read the complete document