Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
PROPRANOLOL HYDROCHLORIDE
B & S Healthcare
PROPRANOLOL HYDROCHLORIDE
160 Milligram
Prolonged Release Capsules
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PATIENT INFORMATION LEAFLET INDERAL LA ® 160MG PROLONGED-RELEASE CAPSULES (PROPRANOLOL HYDROCHLORIDE) 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. IN THIS LEAFLET: 1. What Inderal is and what it is used for 2. Before you take Inderal 3. How to take Inderal 4. Possible side effects 5. How to store Inderal 6. Further information 1. WHAT INDERAL IS AND WHAT IT IS USED FOR The name of your medicine is Inderal LA Prolonged-release Capsules 160mg (called Inderal in the rest of this leaflet). Inderal contains a medicine called propranolol hydrochloride. This belongs to a group of medicines called beta-blockers. Inderal is used for many conditions including: • High blood pressure (hypertension). • Chest pain (angina). • Protecting the heart after a heart attack. • Preventing migraines. • Essential tremor (shaking with an unknown cause). • Anxiety. • Some thyroid problems (such as thyrotoxicosis which is caused by an overactive thyroid gland). • Prevention of bleeding in the food pipe (oesophagus) caused by high blood pressure in the liver. It works by the effects it has on the heart and circulation and also on other parts of the body. 2. BEFORE YOU TAKE INDERAL DO NOT TAKE INDERAL IF: • YOU OR ANYONE IN YOUR FAMILY HAS EVER HAD ASTHMA OR WHEEZING. • You are allergic (hypersensitive) to propranolol hydrochloride or any of the other ingredients in Inderal (see section 6: Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Inderal LA 160mg Prolonged Release Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 160mg Propranolol Hydrochloride. For a full list of excipients see 6.1. 3 PHARMACEUTICAL FORM Prolonged-release Capsules _Product imported from the UK:_ Pink/lavender prolonged release capsules marked ‘Inderal LA’ in white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS i) Control of hypertension. ii) Management of Angina Pectoris. iii) Prophylaxis of migraine. iv) Management of essential tremor v) Control of anxiety vi) Prophylaxis of upper gastrointestinal bleeding in patients with portal hypertension and oesophageal varices vii) Adjunctive management of thyrotoxicosis viii) Long-term prophylaxis after recovery from acute myocardial infarction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. The capsule must not be chewed, but swallowed whole to ensure a prolonged release action. Since the half-life may be increased in patients with significant hepatic or renal impairment, care should be taken when starting treatment and selecting the initial dose. ADULTS _Hypertension:_ The usual starting dose is one 160mg Inderal LA capsule daily, taken either morning or evening. An adequate response is seen in most patients at this dosage. If necessary, it can be increased in 80mg Half Inderal LA increments until adequate response is achieved. A further reduction in BP can be attained if a diuretic or other antihypertensive agent is given in addition to Inderal LA and Half-Inderal LA. One Half-Inderal LA capsule 80mg daily is unlikely on its own to be sufficient to treat hypertension but it may be used as a starting dose in appropriate patients (e.g. the elderly) or to provide a convenient method of gradual Baca dokumen lengkap