Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Propranolol hydrochloride
Azure Pharmaceuticals Ltd
C07AA05
Propranolol hydrochloride
Film-coated tablet
propranolol
Not marketed
2023-12-08
1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER PROPRANOLOL AZURE 10 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, as 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Propranolol Azure is and what it is used for 2. What you need to know before you take Propranolol Azure 3. How to take Propranolol Azure 4. Possible side effects 5. How to store Propranolol Azure 6. Contents of the pack and other information 1. WHAT PROPRANOLOL AZURE IS AND WHAT IT IS USED FOR Propranolol Azure belongs to a group of medicines called beta-blockers, which act on different levels in the body including the heart. Propranolol Azure is indicated for: - Treatment of high blood pressure (hypertension). - Treatment of chest pain (angina). - Treatment of certain heart disorders (obstructive hypertrophic cardiomyopathy). - Control of irregular heartbeats (arrhythmias). - Protection of the heart after a myocardial infarction. - Migraine (headache) prevention. - Treatment of tremors. - Treatment of anxiety symptoms. - Treatment of certain thyroid disorders (thyrotoxicosis). - Treatment of pheochromocytoma (high blood pressure due to a tumour usually near the kidney) administered together with another treatment: an alpha-adrenergic blocking agent. - Prevention of bleeding in the esophagus caused by high blood pressure in the liver. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPRANOLOL AZURE DO NOT TAKE PROPRANOLOL AZURE - If you are allergic (hypersensitive) to propranolol or to any of the other ingredients of this medicine Preberite celoten dokument
Health Products Regulatory Authority 11 December 2023 CRN00DPF9 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Propranolol Azure 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of propranolol hydrochloride. Excipient(s) with known effect: Each tablet contains 75.01 mg of lactose, around 0.04 mg of sunset yellow FCF (E-110) and 0.01 mg of allura red AC (E-129). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink, round film-coated tablets scored on one 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 Treatment of renal and essential arterial hypertension. Treatment of angina pectoris. Long-term prophylaxis after recovery from acute myocardial infarction. Treatment of tachyarrhythmias. Migraine prophylaxis. Treatment of essential tremor. Treatment of peripheral symptoms of anxiety (tachycardia, tremor). Prophylaxis of upper gastrointestinal bleeding in patients with portal hypertension and oesophageal varices. Coadjuvant treatment of thyrotoxicosis. Treatment of hypertrophic obstructive cardiomyopathy. Treatment of pheochromocytoma (in conjunction with an alpha-adrenergic blocker). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION As the half-life may be increased in patients with significant hepatic or renal insufficiency, caution should be exercised when starting treatment and the starting dose should be selected by adjusting the dosage to the degree of insufficiency. Posology _ADULTS_ _Hypertension:_ The initial dose is 80 mg of propranolol twice a day, which may be increased in weekly intervals according to the response. The usual dose range is 160-320 mg per day and the maximum daily dose should not exceed 640 mg per day (see Table 1). With the concomitant administration of a diuretic or other antihypertensive treatment, a greater reduction Preberite celoten dokument