Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Latanoprost; Timolol
Accord Healthcare Ireland Ltd.
S01ED; S01ED51
Latanoprost; Timolol
50 mcg/ml + 5 milligram(s)/millilitre
Eye drops, solution
Beta blocking agents1); timolol, combinations
Marketed
2011-08-26
PACKAGE LEAFLET: INFORMATION FOR THE USER LATANOPROST/TIMOLOL 50 MICROGRAM/5.0 MG PER 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 LATANOPROST/TIMOLOL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL 3. HOW TO USE LATANOPROST/TIMOLOL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE LATANOPROST/TIMOLOL 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT LATANOPROST/TIMOLOL IS AND WHAT IT IS USED FOR Latanoprost/Timolol contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye. Latanoprost/Timolol is used to reduce the pressure in your eye if you have conditions known as open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within your eye, eventually affecting your eyesight. Your doctor will usually prescribe you Latanoprost/Timolol when other medicines have not worked adequately. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL Latanoprost/Timolol can be used in adult men and women (including the elderly), but is not recommended for use if you are less than 18 years of age. DO NOT USE LATANOPROST/TIMOLOL: if you are allergic (hypersensitive) to latanoprost, timolol, beta Prečítajte si celý dokument
Health Products Regulatory Authority 17 January 2020 CRN009JZT Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Latanoprost / Timolol 50 microgram/5.0 mg per ml Eye Drops Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 50 microgram latanoprost and 6.8 mg timolol maleate equivalent to 5 mg timolol. Excipient with known effect: Benzalkonium chloride 0.2 mg/ml (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. The solution is a clear, colourless liquid. Osmolality: 280~320 mOsmol/kg pH: 5.0 – 7.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Latanoprost-Timolol is indicated in adults (including the elderly) for the 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 _Recommended dosage 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. _ _ _Paediatric population: _ The safety and efficacy of Latanoprost-Timolol in children and adolescents has not been established. 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). 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. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. 4.3 CONTRAINDICATIONS Latanoprost-Timolol is contraindicated in patients with: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Reactive air Prečítajte si celý dokument