Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
BETAXOLOL HYDROCHLORIDE
Novartis Pharmaceuticals UK Ltd
S01ED02
BETAXOLOL HYDROCHLORIDE
0.5 %w/v
Eye Drops Solution
Product subject to prescription which may be renewed (B)
Beta blocking agents
Authorised
2017-05-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betoptic 0.5% w/v Eye Drops, Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betaxolol 0.5% w/v (as hydrochloride). Excipients with known effect: Benzalkonium chloride 0.01% w/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betoptic 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 _Adults (including the elderly)_ The usual dose is one drop to be instilled into the affected eye(s) twice daily. _Children_ Betoptic is not recommended for use in children. 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. After cap is removed, if tamper evident snap collar is loose, remove before using product. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in 6.1. 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. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For ocular use only H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lesen Sie das vollständige Dokument