Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVOBUNOLOL HYDROCHLORIDE
PCO Manufacturing
0.5 %w/v
Ear Drops Solution
2008-01-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betagan 0.5% w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Levobunolol hydrochloride 0.5% w/v _Product imported from Spain:_ Clear, viscous, sterile, colourless to light yellow eye drops solution Excipients: Benzalkonium chloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, viscous, sterile, colourless to light yellow eye drops solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the control of intraocular pressure in chronic open angle glaucoma and ocular hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elderly): the recommended dosage of Betagan is one drop in the affected eye(s) once or twice daily. Betagan is not recommended for use in children due to lack of safety and efficacy data (see section 5.1.). Method of administration: topical into the conjunctival sac. Concurrant therapy may be used where necessary. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctual occlusion) for one minute. This should be performed immediately following the instillation of each drop. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Bronchial asthma (or a history of bronchial asthma) or chronic obstructive pulmonary disease. Uncontrolled cardiac failure. History of sinus bradycardia, second and third-degree atrioventricular block, overt cardiac failure or cardiogenic shock. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/04/2011_ _CRN 2091804_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR Read the complete document