Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
LATANOPROST
Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom
S01EE01
LATANOPROST 50 µg/ml
EYE DROPS, SOLUTION
LATANOPROST 50 µg/ml
POM
OPHTHALMOLOGICALS
Withdrawn
2016-02-19
PACKAGE LEAFLET: INFORMATION FOR THE USER LATANOPROST 50 MICROGRAMS/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 or your child’s doctor or pharmacist. - This medicine has been prescribed for you or for your child. 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 or your child’s doctoror pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What latanoprost eye drops are and what it is used for 2. What you need to know before you use latanoprost eye drops 3. How to use latanoprost eye drops 4. Possible side effects 5. How to store latanoprost eye drops 6. Contents of the pack and other information 1. WHAT LATANOPROST EYE DROPS ARE AND WHAT IT IS USED FOR 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. Latanoprost contains the active substance Latanoprost 0.005% w/v (50 micrograms per ml) eye drops solution. Latanoprost is used to treat conditions known as open angle glaucoma and ocular hypertension. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eye sight. Latanoprost 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 EYE DROPS Latanoprost can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latanoprost has not been investigated in prematurely born infants (less than 36 weeks gestation). DO NOT USE LATANOPROST EYE DROPS - if you are ALLERGIC (hypersensitive) to the active substance latanoprost or any of the oth Lesen Sie das vollständige Dokument
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Latanoprost 50 micrograms/ml eye drops solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml eye drops solution contains 50 micrograms latanoprost. One drop contains approximately 1.5 micrograms latanoprost. Excipient with known effects: Benzalkonium chloride 0.02% w/v (0.21mg/ml) is included as a preservative. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless solution practically free from particles filled in 5 ml FFS vial. pH: 6.40-7.00 Osmolality: 240-300 mOsmols / kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Latanoprost in indicated for reduction of elevated intraocular pressure • in patients with open angle glaucoma and ocular hypertension. • in paediatric patients with elevated intraocular pressure and paediatric glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Recommended dosage for adults (including the elderly): _ Page 2 of 12 Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Latanoprost eye drops is administered in the evening. The dosage of Latanoprost eye drops 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 is 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 drug is being used, the drugs should be administered at least five minutes apart. _Paediatric population _ Latanoprost eye drops may be used in paediatric patients at the same posology as in adults. No data are availa Lesen Sie das vollständige Dokument