Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
PROPRANOLOL HYDROCHLORIDE
B & S Healthcare
160 Milligram
Prolonged Release Capsules
2009-05-08
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 Les hele dokumentet