Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
TRAVOPROST
1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany
S01EE04
TRAVOPROST 40 µg
EYE DROPS, SOLUTION
TRAVOPROST 40 µg
POM
OPHTHALMOLOGICALS
Withdrawn
2017-08-22
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER Travoprost 40 micrograms/ml eye drops, solution travoprost 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 Travoprost is and what it is used for 2. What you need to know before you use Travoprost 3. How to use Travoprost 4. Possible side effects 5. How to store Travoprost 6. Contents of the pack and other information 1. WHAT TRAVOPROST IS AND WHAT IT IS USED FOR Travoprost contains travoprost, one of a group of medicines called prostaglandin analogues. It works by reducing the pressure in the eye. It may be used on its own or with other drops e.g. beta-blockers, which also reduce pressure. Travoprost is used to reduce high pressure in the eye in adults, adolescents and children from 2 months old onward. This pressure can lead to an illness called glaucoma. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRAVOPROST DO NOT USE TRAVOPROST if you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6). Ask your doctor for advice if this applies to you. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Travoprost Page 2 of 7 - Travoprost may increase the length, thickness, colour and/or number of your eyelashes. Changes in the eyelids including unusual hair growth or in the tissues around the eye have also been observed. - Travoprost may change the colour of your iris (the coloured part of your eye). This change may be permanent. A change in the colour of the skin around the eye may also oc Přečtěte si celý dokument
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _ _ Travoprost 40 micrograms/ml eye drops, solution _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ 1 ml of solution contains 40 micrograms of travoprost. Excipients with known effect: 1 ml of solution contains benzalkonium chloride solution (equivalent to 0.15 mg benzalkonium chloride), 5 mg macrogolglycerol hydroxystearate 40 (see section 4.4.). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless solution. pH: 5.5 – 6.5. Osmolality: 265-320 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in pediatric patients aged 2 months to <18 years with ocular hypertension or pediatric glaucoma (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For ocular use. Posology _Use in adults, including elderly population _ The dose is one drop of Travoprost in the conjunctival sac of the affected eye(s) once daily. Optimal effect is obtained if the dose is administered in the evening. Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart (see section 4.5). If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. Page 2 of 9 When substituting another ophthalmic antiglaucoma medicinal product with travoprost, the other medicinal product should be discontinued and travoprost should be started the following day. _Hepatic and renal impairment _ Travoprost has been studied in patients with mild t Přečtěte si celý dokument