Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Latanoprost
Teva Pharma B.V.
S01EE; S01EE01
Latanoprost
50 microgram(s)/millilitre
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Prostaglandin analogues1); latanoprost
Not marketed
2012-10-19
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Latanoprost Teva 50 micrograms/ml eye drop solution Latanoprost 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 Teva 50 micrograms/ml eye drop solution is and what it is used for 2. What you need to know before you use Latanoprost Teva 50 micrograms/ml eye drop solution 3. How to use Latanoprost Teva 50 micrograms/ml eye drop solution 4. Possible side effects 5. How to store Latanoprost Teva 50 micrograms/ml eye drop solution 6. Contents of the pack and other information 1. WHAT LATANOPROST TEVA 50 MICROGRAMS/ML EYE DROP SOLUTION IS AND WHAT IT IS USED FOR Latanoprost Teva 50 micrograms/ml eye drop solution belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream. Latanoprost Teva 50 micrograms/ml eye drop solution is used to treat conditions known as open angle glaucoma and ocular hypertension in adults. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eye sight. Latanoprost Teva 50 micrograms/ml eye drop solution is also used to treat increased eye pressure and glaucoma in all ages of children and babies. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST TEVA 50 MICROGRAMS/ML EYE DROP SOLUTION Latanoprost Teva 50 micrograms/ml eye drop solution can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latanoprost Teva 50 microgr Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 20 August 2019 CRN008JQ9 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Latanoprost Teva 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml eye drops solution contains 50 micrograms of latanoprost. 2.5 ml eye drops solution contains 125 micrograms of latanoprost corresponding to approximately 80 drops of solution. One drop contains approximately 1.56 micrograms of latanoprost. Excipients with known effect: Benzalkonium chloride 0.2 mg/ml. -Phosphates 17.2 mg/ml For the 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 Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension. Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma. 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. Optimal effect is obtained if Latanoprost Teva 50 micrograms/ml eye drop solution is administered in the evening. The dosage of Latanoprost Teva 50 micrograms/ml eye drop solution should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect. If one dose is missed, treatment should continue with the next dose as normal. METHOD OF ADMINISTRATION: Ocular use As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop. Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least five minutes apart. _ _ _Paediatr Olvassa el a teljes dokumentumot