Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
LATANOPROST, TIMOLOL MALEATE
Actavis Group PTC ehf
S01ED51
LATANOPROST, TIMOLOL MALEATE
50mcg/ml + 5 Mg/Ml
Eye Drops Solution
Product subject to prescription which may not be renewed (A)
Beta blocking agents
Authorised
2013-05-03
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Latanoprost/Timolol 50 microgram/ml + 5 mg/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 active substances: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol belongs to a group of medicines known as beta-blockers. It 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 Latanoprost/Timolol when other medicines have not worked adequately. 2 Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Latanoprost/Timolol 50 micrograms/ml + 5mg/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 with known effect: Benzalkonium chloride 0.2 mg/ml eye drops. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution (eye drops). The solution is a clear, colourless liquid. 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 _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 50 microgram/ml + 5 mg/ml eye drops, solution in children and adolescents has not been established. _Method of administration_ Ocular use. 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 medicinal products 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. 4.3 CONTRAINDICATIONS Latanoprost/Timolol 50 microgram/ml + 5 mg/ml eye drops, solution is contraindica Lugege kogu dokumenti