Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
LATANOPROST TIMOLOL MALEATE
Clonmel Healthcare Ltd
LATANOPROST TIMOLOL MALEATE
0.05/5 Mg/Ml
Eye Drops Solution
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ZANOPRO PLUS 50MICROGRAMS/ML AND 5MG/ML EYE DROPS, SOLUTION Latanoprost / Timolol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zanopro Plus is and what it is used for 2. What you need to know before you use Zanopro Plus 3. How to use Zanopro Plus 4. Possible side effects 5. How to store Zanopro Plus 6. Contents of the pack and other information 1. WHAT ZANOPRO PLUS IS AND WHAT IT IS USED FOR Zanopro Plus is a medicine for the treatment of INCREASED INTRAOCULAR PRESSURE (pressure inside the eye). Zanopro Plus is a drug combination containing two active substances: latanoprost (a prostaglandin derivative) and timolol maleate (a beta-blocker). Fluid known as aqueous humour is produced inside the eye. This fluid is then drained back into the bloodstream, thereby maintaining the required pressure within the eye. If this outflow is obstructed, pressure within the eye increases. Among other things, beta-blockers reduce pressure inside the eye, by reducing the production of aqueous humour. Prostaglandins promote the outflow of aqueous humour. ZANOPRO PLUS IS USED: to reduce inner eye pressure in patients with open-angle glaucoma (damage to the optic nerve, caused by excessive pressure within the eye). to reduce inner eye pressure in patients for whom the effect o Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zanopro Plus 50 micrograms/ml and 5 mg/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 50 micrograms latanoprost and 6.8 mg timolol maleate equivalent to 5 mg timolol. Excipient: Benzalkonium chloride 0.2 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution The solution is a clear colourless liquid. pH 5.5 - 6.5; osmolality 270 - 330 mOsmol/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology for adults (including the elderly): Recommended therapy is one eye drop in the affected eye(s) once daily. If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. Method of administration: Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes (see section 4.4). If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. 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. Paediatric population: Safety and effectiveness in children and adolescents has not been established. 4.3 CONTRAINDICATIONS Latanoprost/timolol is contraindicated in patients with: - Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmona Lestu allt skjalið