Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Latanoprost
Rowex Ltd
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
2011-09-09
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LATOP 50 MICROGRAM/ML EYE DROPS, 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 Latop is and what it is used for 2. What you need to know before you use Latop 3. How to use Latop 4. Possible side effects 5. How to store Latop 6. Contents of the pack and other information 1. WHAT LATOP IS AND WHAT IT IS USED FOR Latop contains the active substance latanoprost. Latanoprost 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. Latop 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. Latop 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 LATOP Latop can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latop has not been investigated in prematurely born infants (less than 36 weeks gestation). DO NOT USE LATOP If you are ALLERGIC to latanoprost or any of the other ingredients of this medicine (listed in section 6) If you are pregnant or trying to become pregnant If you are breast-feeding. WARNINGS AND PRECAUTIONS Talk to your doctor or the doctor treating your child or pharmacist before using Latop or before you give this to Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Latop 50 microgram/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution contains 50 micrograms of latanoprost (equivalent to 0.005% w/v). Each drop contains approximately 1.5 micrograms latanoprost. Excipient with known effect Each ml contains 0.2 mg benzalkonium chloride (equivalent to 0.02% w/v) and 6.34 mg/ml phosphate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. 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 ] Latop is administered in the evening. The dose of latanoprost 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. 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. _Paediatric population:_ Latop may be used in paediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age). Data in the age group < 1 year (4 patients) are very limited (see Lire le document complet