Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Latanoprost; Timolol
Pfizer Healthcare Ireland
S01ED; S01ED51
Latanoprost; Timolol
50mcg/ml + 5 milligram(s)/millilitre
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Beta blocking agents1); timolol, combinations
Marketed
2001-09-07
Page 1 of 9 2019-0056117 PACKAGE LEAFLET: INFORMATION FOR THE USER XALACOM ® 50 MICROGRAMS/ML AND 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 Preberite celoten dokument
Health Products Regulatory Authority 30 September 2020 CRN009L06 Page 1 of 9 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. Excipients with known effect: Benzalkonium chloride 0.2 mg/mL Disodium phosphate (E339ii), sodium dihydrogen phosphate monohydrate (E339i) (containing total phosphate 6.3 mg/mL) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. The solution is a clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xalacom is indicated in adults (including the elderly) for the 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly)_ Recommended therapy is one eye drop in the affected eye(s) once daily. If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. _Paediatric population_ The safety and efficacy of Xalacom in children and adolescents has not been established. Method of administration Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes (see section 4.4). If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. 4.3 CONTRAINDICATIONS Xalacom is contraindicated in patients with: Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. Preberite celoten dokument