Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
B & S Healthcare
S01ED51
DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
20/5 Mg/Ml
Eye Drops Solution
Product subject to prescription which may be renewed (B)
Beta blocking agents
Authorised
2011-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER COSOPT ® 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 side effects not listed in this leaflet. See section 4. The name of your medicine is Cosopt 20mg/ml + 5mg/ml eye drops, solution but will be referred to as Cosopt throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Cosopt is and what it is used for 2. What you need to know before you use Cosopt 3. How to use Cosopt 4. Possible side effects 5. How to store Cosopt 6. Contents of the pack and other information 1. WHAT COSOPT IS AND WHAT IT IS USED FOR Cosopt contains 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”. These medicines lower the pressure in the eye in different ways. Cosopt is prescribed to lower raised pressure in the eye in the treatment of glaucoma when beta-blocker eyedrop medicine used alone is not adequate. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE COSOPT DO NOT USE COSOPT • if you are allergic to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in section 6). • if you have now or had in the past respiratory problems, such as asthma or severe chronic obstructive bronchiti Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT COSOPT 20mg/ml + 5mg/ml eye drops, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding to 20 mg dorzolamide and 6.83 mg of timolol maleate corresponding to 5 mg timolol. Excipients: Benzalkonium chloride 0.075 mg/ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution _Product imported from UK and Italy:_ Clear, colourless to nearly colourless, slightly viscous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated in the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or pseudoexfoliative glaucoma when topical beta-blocker monotherapy is not sufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose is one drop of COSOPT in the (conjunctival sac of the) affected eye(s) two times daily. If another topical ophthalmic agent is being used, COSOPT and the other agent should be administered at least ten minutes apart. Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures. 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 OCUMETER PLUS bottles. _Usage Instructions_ 1. Before using the medication for the first time, be sure the Safety Strip on the front of the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle. 2. Tear off the Safety Str Belgenin tamamını okuyun