Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
BETAXOLOL HYDROCHLORIDE
Alcon Laboratories (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
1986-08-27
64087-6 BETOPTIC ® 0.5 % W/V EYE DROPS, SOLUTION BETAXOLOL (AS HYDROCHLORIDE) PACKAGE LEAFLET - INFORMATION FOR THE USER CONTINUED OVER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE • KEEP THIS LEAFLET. You may need to read it again. • IF YOU HAVE ANY FURTHER QUESTIONS, ask your doctor or your pharmacist. • This medicine has been prescribed for you. DO NOT PASS IT ON TO OTHERS. It may harm them, even if their symptoms are the same as yours. • IF ANY OF THE SIDE EFFECTS GET SERIOUS, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. HOW TO USE • Wash your hands before you start. • Twist off the bottle cap. • Hold the bottle pointing down, between your thumb and fingers. • Tilt your head back. • Pull down your lower eyelid with a finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here (picture 1). • Bring the bottle tip close to the eye. Do this in front of a mirror if it helps. • DO NOT TOUCH YOUR EYE OR EYELID, surrounding areas or other surfaces with the dropper. It could infect the drops. • GENTLY PRESS ON THE BASE of the bottle to release one drop at a time (picture 2). • DO NOT SQUEEZE THE BOTTLE, only a gentle press on the bottom is needed. • If you use drops in both eyes, repeat the steps for your other eye. Put the bottle cap firmly back on immediately after use. • After using BETOPTIC 0.5 %, PRESS A FINGER INTO THE CORNER OF YOUR EYE BY THE NOSE (picture 3) for 2 minutes. This helps to stop betaxolol getting into the rest of the body. • IF A DROP MISSES YOUR EYE, try again. • IF YOU MISS A DOSE, just take it as soon as possible. However, if it is almost time for your next dose, skip the miss Lestu allt skjalið
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 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 06/11/2015_ _CRN 2170176_ _page number: 1_ GENERAL: Like other topically applied ophthalmic agents, betax Lestu allt skjalið