Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
travoprost, timolol
Novartis Europharm Limited
S01ED51
travoprost, timolol
Ophthalmologicals
Glaucoma, Open-Angle; Ocular Hypertension
Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Revision: 18
Authorised
2006-04-23
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE USER DUOTRAV 40 MICROGRAMS/ML + 5 MG/ML EYE DROPS, SOLUTION travoprost/timolol 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 DuoTrav is and what it is used for 2. What you need to know before you use DuoTrav 3. How to use DuoTrav 4. Possible side effects 5. How to store DuoTrav 6. Contents of the pack and other information 1. WHAT DUOTRAV IS AND WHAT IT IS USED FOR DuoTrav eye drop solution is a combination of two active substances (travoprost and timolol). Travoprost is a prostaglandin analogue which works by increasing the outflow of aqueous fluid from the eye, which lowers its pressure. Timolol is a beta blocker which works by reducing the production of fluid within the eye. The two substances work together to reduce pressure within the eye. DuoTrav eye drops are used to treat high pressure in the eye in adults, including the elderly . This pressure can lead to an illness called glaucoma. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DUOTRAV DO NOT USE DUOTRAV if you are allergic to travoprost, prostaglandins, timolol, beta blockers or any of the other ingredients of this medicine (listed in section 6). if you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough), or other types of breathing problems. if you have severe hay fever. if you have a slow heartbeat, heart f Soma hati kamili
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate). Excipient(s) with known effect Each mL of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5 mg and polyoxyethylene hydrogenated castor oil 40 1 mg (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution (eye drops). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DuoTrav is indicated in adults for the decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta blockers or prostaglandin analogues (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Use in adults, including the elderly _ The dose is one drop of DuoTrav in the conjunctival sac of the affected eye(s) once daily, in the morning or evening. It should be administered at the same time each day. 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. _Special populations _ _Hepatic and renal impairment _ No studies have been conducted with DuoTrav or with timolol 5 mg/mL eye drops in patients with hepatic or renal impairment. Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 mL/min). No dose adjustment was necessary in these patients. Patients with hepatic or renal impairment are unlikely to require dose adjustment with DuoTrav (see section 5.2). 3 _Paediatric population _ The safety and efficacy of DuoTrav in children and adolescents below the age of 18 years have not been established. No data are available. Method of administration For ocular use. The pa Soma hati kamili