País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Dorzolamide; Timolol
Accord Healthcare Ireland Ltd.
S01ED; S01ED51
Dorzolamide; Timolol
20 mg/ml+5 milligram(s)/millilitre
Eye drops, solution
Beta blocking agents1); timolol, combinations
Not marketed
2011-08-12
PACKAGE LEAFLET: INFORMATION FOR THE USER DORZOLAMIDE/TIMOLOL 20 MG/ML + 5 MG/ML EYE DROPS, SOLUTION Dorzolamide / 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 Dorzolamide/Timolol is and what it is used for 2. What you need to know before you use Dorzolamide/Timolol 3. How to use Dorzolamide/Timolol 4. Possible side effects 5. How to store Dorzolamide/Timolol 6. Contents of the pack and other information 1. WHAT DORZOLAMIDE/TIMOLOL IS AND WHAT IT IS USED FOR Dorzolamide/Timolol is a combination of two medicines: dorzolamide and timolol. Dorzolamide belongs to a group of medicines called “carbonic anhydrase inhibitors”. Timolol belongs to a group of medicines called “beta blockers”. Dorzolamide/Timolol is prescribed to lower raised pressure within the eye in the treatment of glaucoma when beta-blocker eye drops used alone are not adequate. 2. WHAT YOU NEED TO NOW BEFORE YOU USE DORZOLAMIDE/TIMOLOL DO NOT USE DORZOLAMIDE/TIMOLOL: - if you are allergic to dorzolamide or 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 lung disease (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough), - if you have severe kidney problems, or a prior history of kidney stones, - if you have a disturbance in the pH (acid/alkali balance) of your blood, - if you have certain heart problems, including certai Llegiu el document complet
Health Products Regulatory Authority 15 May 2020 CRN009L1Y Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dorzolamide/Timolol 20 mg/ml + 5 mg/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 20 mg dorzolamide (as Dorzolamide hydrochloride) and 5 mg timolol (as timolol maleate). Excipient with known effect: each ml of eye drops solution contains 0.075 mg benzalkonium chloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, slightly viscous, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dorzolamide/Timolol is indicated in the treatment of elevated intra-ocular pressure (IOP) in patients with open-angle glaucoma or pseudo-exfoliative glaucoma when topical beta-blocker monotherapy is not sufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose is one drop of Dorzolamide/Timolol in the (conjunctival sac of the) affected eye(s) two times daily. If another topical ophthalmic medicinal product is being used, the other agent should be administered at least ten minutes apart. _Paediatric population_ Efficacy in paediatric patients has not been established. Safety in paediatric patients below the age of two years has not been established. (For information regarding safety in paediatric patients ≥ 2 and < 6 years of age, see section 5.1). Method of administation Patients should be instructed to wash their hands before use and avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. In order to secure correct dosage - the dropper tip should not be enlarged. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Patients should be informed of the correct handling of the ophthalmic _Dorzolamide/Timolol._ 1. The tamper-pro Llegiu el document complet