Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Latanoprost; Timolol
PCO Manufacturing Ltd.
S01ED; S01ED51
Latanoprost; Timolol
50mcg/ml + 5 milligram(s)/millilitre
Eye drops, solution
Eye solution use
Pack sizes: 1 × 2.5 ml
Product subject to prescription which may not be renewed (A)
Pfizer Manufacturing Belgium
Ophthalmological-betablocking agents - timolol, combinations
Beta blocking agents1); timolol, combinations
Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues
Authorised
2015-04-17
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER XALACOM ® 50 MICROGRAMS/ML + 5 MG/ML, EYE DROPS, SOLUTION latanoprost/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 Xalacom is and what it is used for 2. What you need to know before you use Xalacom 3. How to use Xalacom 4. Possible side effects 5. How to store Xalacom 6. Contents of the pack and other information 1. WHAT XALACOM IS AND WHAT IT IS USED FOR Xalacom contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye. Xalacom is used to reduce the pressure in your eye if you have conditions known as open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within your eye, eventually affecting your eyesight. Your doctor will usually prescribe you Xalacom when other medicines have not worked adequately. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE XALACOM Xalacom can be used in adult men and women (including the elderly), but is not recommended for use if you are less than 18 years of age. DO NOT USE XALACOM: • if you are allergic (hypersensitive) to either of the medicines in Xalacom (latanoprost or timolol), beta-blockers, or any of the other ingredients of Xalacom (listed in section 6) • if yo Прочитайте повний документ
Health Products Regulatory Authority 26 February 2024 CRN00F3FQ Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xalacom 50 micrograms/ml + 5 mg/ml, eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains latanoprost 50 micrograms and timolol maleate 6.8 mg equivalent to 5 mg timolol. Excipient(s) with known effect: Benzalkonium chloride, Disodium phosphate anhydrous (E339ii), Sodium dihydrogen phosphate monohydrate (E339i). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. _Product imported from Greece, Lithuania and Belgium_ The solution is a clear, colourless liquid. 4 CLINICAL PARTICULARS As per PA23055/008/001 5 PHARMACOLOGICAL PROPERTIES As per PA23055/008/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium chloride Benzalkonium chloride Sodium dihydrogen phosphate monohydrate (E339i) Disodium phosphate anhydrous (E339ii) Hydrochloric acid solution (for adjustment to pH 6.0) Sodium hydroxide solution (for adjustment to pH 6.0) Water for injections 6.2 INCOMPATIBILITIES In vitro studies have shown that precipitation occurs when eye drops containing thiomersal are mixed with Xalatan. If such drugs are used concomitantly with Xalacom, the eye drops should be administered with an interval of at least five minutes. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer carton of the product as marketed in the country of origin. After opening of container: 4 weeks Health Products Regulatory Authority 26 February 2024 CRN00F3FQ Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Before first opening: Store in a refrigerator (2°C - 8°C) After first opening: Do not store above 25°C. Use within 4 weeks (see section 6.3). Keep the bottle in the outer carton in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Dropper container (5ml) with a screw cap and tamper evident overcap. Each bottle contains 2.5 ml eye drop solution. Pack sizes: 1 × 2.5 Прочитайте повний документ