Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Latanoprost
Accord Healthcare Ireland Ltd.
S01EE; S01EE01
Latanoprost
50 microgram(s)/millilitre
Eye drops, solution
Prostaglandin analogues1); latanoprost
Marketed
2011-01-28
PACKAGE LEAFLET: INFORMATION FOR THE USER LATANOPROST 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 the doctor treating your child or your pharmacist. - This medicine has been prescribed for you or for your child 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 or your child get any side effects, talk to your doctor or the doctor treating your child or your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Latanoprost is and what it is used for 2. What you need to know before you use Latanoprost 3. How to use Latanoprost 4. Possible side effects 5. How to store Latanoprost 6. Contents of the pack and other information 1. WHAT LATANOPROST IS 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 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 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 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 IF YOU ARE Allergic (hypersensitive) to latanoprost or any of the other ingredients of this medicine (listed in section 6) Pregnant or trying to become pregnant Breast feeding WARNINGS AND P Läs hela dokumentet
Health Products Regulatory Authority 06 May 2022 CRN00CVC7 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Latanoprost 50 microgram/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml eye drops, solution, contains 50 microgram latanoprost. One drop contains approximately 1.5 microgram latanoprost. Excipient with known effect: Benzalkonium chloride 0.2 mg/ml. Sodium dihydrogen phosphate monohydrate 4.60 mg.ml Disodium phosphate 4.74 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution The solution is a clear colourless liquid. pH 6.4-7.0. Osmolality 240-290 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension in adults (including the elderly). Reduction of elevated IOP in paediatric patients with elevated IOP 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 is administered in the evening. The dosage of Latanoprost should not exceed once daily since it has been shown that more frequent administration decreases the IOP lowering effect. If one dose is missed, treatment should continue with the next dose as normal. Method of administration 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_ Health Products Regulatory Authority 06 May 2022 CRN00CVC7 Page 2 of 9 Latanop Läs hela dokumentet