国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Dorzolamide; Timolol
PCO Manufacturing Ltd.
S01ED; S01ED51
Dorzolamide; Timolol
20 mg/ml + 5 milligram(s)/millilitre
Eye drops, solution
Product subject to prescription which may be renewed (B)
Beta blocking agents1); timolol, combinations
Authorised
2012-10-05
_ _ _ _ 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. 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 bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough). • if you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats). • if you have severe kidney disease or problems, or a prior history of kidney stones. • if you have excess acidity of the blood caused by a build u 阅读完整的文件
Health Products Regulatory Authority 09 January 2024 CRN00F16Y Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT COSOPT 20 mg/ml + 5 mg/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. Excipient(s) with known effect: benzalkonium chloride For the full list of the excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. _Product imported from France, Italy, Greece and Romania:_ Clear, colourless or nearly colourless, slightly viscous solution with a pH between 5.5 and 5.8 and an osmolarity of 242‒323 mOsM 4 CLINICAL PARTICULARS As per PA0879/005/001 5 PHARMACOLOGICAL PROPERTIES As per PA0879/005/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Benzalkonium chloride Hydroxyethyl cellulose Mannitol (E 421) Sodium citrate (E 331) Sodium hydroxide for pH adjustment Water for injections 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Cosopt should be used no longer than 28 days after first opening the container. Health Products Regulatory Authority 09 January 2024 CRN00F16Y Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special temperature storage conditions. Keep the container in the outer carton in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Two alternate containers may be marketed. White translucent plastic container, a dropper and a white screw cap. One container contains 5 ml of solution. or The OCUMETER Plus Ophthalmic Dispenser consists of a translucent container with a sealed dropper tip, a flexible fluted side area which is depressed to dispense the drops, and a 2-piece cap assembly. One dispenser unit containing 5 ml in a cardboard carton. Tamper evidence is provided 阅读完整的文件