Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Latanoprost
Zaklady Farmaceutyczne POLPHARMA S.A.
S01EE01
Latanoprost
Eye drops, solution
latanoprost
2022-01-07
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LORAVIS 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 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 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 Loravis is and what it is used for 2. What you need to know before you use Loravis 3. How to use Loravis 4. Possible side effects 5. How to store Loravis 6. Contents of the pack and other information 1. WHAT LORAVIS IS AND WHAT IT IS USED FOR Loravis contains latanoprost and it belongs to a group of medicines known as prostaglandin analogues. It lowers the pressure within your eye by increasing the natural outflow of fluid from inside the eye into the blood stream. Loravis is used to treat a type of glaucoma called OPEN ANGLE GLAUCOMA and also a condition known as OCULAR HYPERTENSION in adults. Both of these conditions are linked with an increase in the pressure within your eye and eventually they may affect your eyesight. Loravis 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 LORAVIS Loravis can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Loravis has not been investigated in prematurely born infants (less than 36 weeks gestation). DO NOT USE LORAVIS if you are ALLERGIC to latanoprost or any of the other ingredients of this medicine (listed in section 6) WARNINGS AND PRECAUTIONS Talk to your doctor, or the doctor treating your child or pharmacist before using Loravis: if you or your Preberite celoten dokument
Health Products Regulatory Authority 23 October 2023 CRN00DRSP Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loravis 50 microgram/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms of latanoprost. Each drop contains approximately 1.5 micrograms of latanoprost. Excipient(s) with known effect: Each ml of eye drops, solution contains 6.4 mg (0.2 mg per drop) of phosphates (as disodium phosphate and sodium dihydrogen phosphate monohydrate). 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. pH is in the range of 5.5 to 6.5 Osmolality is in the range of 250 to 320 mOsmol/kg 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 _Recommended dosage for 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 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 products is being used, the medicinal products should be administered at least five minutes apar Preberite celoten dokument