Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PROPRANOLOL HYDROCHLORIDE
IPS Healthcare Limited
160 Milligram
Prolonged Release Capsules
2011-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Inderal LA Prolonged-release Capsules 160mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Propranolol hydrochloride 160 mg For full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Prolonged-release Capsules, Hard _Product imported from the UK:_ Hard gelatin capsules, consisting of an opaque pale lavender cap and a clear pink body. They are printed in white ink with 'INDERAL LA'. The capsules contain white to pale cream coloured spheroids. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 dose alteration. 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 o Read the complete document