País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
BETAXOLOL HYDROCHLORIDE
Alcon Laboratories (UK) Ltd
S01ED02
BETAXOLOL HYDROCHLORIDE
0.25 %w/v
Eye Drops Suspension
Product subject to prescription which may be renewed (B)
Beta blocking agents
Authorised
1995-07-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betoptic Suspension Single Dose 0.25% w/v, Eye Drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betaxolol (as hydrochloride) 0.25% w/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, suspension A white to off white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BETOPTIC SUSPENSION SINGLE DOSE eye drops contain a cardioselective beta-adrenergic receptor blocker which is indicated for the reduction of elevated intraocular pressure in patients with ocular hypertension and chronic open- angle glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Shake well before each use. ADULTS (INCLUDING THE ELDERLY) The usual dose is one drop twice daily. Standard ocular hypotensive agents may be used to supplement this treatment. CHILDREN Clinical studies to establish the safety and efficacy in children have not been performed up to now. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 Hypersensitivity to beta-adrenoceptor blockers. Reactive airway disease including severe bronchial asthma or a history of severe bronchial asthma, severe chronic obstructive pulmonary disease. Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker. Overt cardiac failure, cardiogenic shock HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 24/05/2016_ _CRN 2177235_ _page number: 1 Leia o documento completo