Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
TIMOLOL MALEATE
Brown & Burk UK LTD
C07AA; C07AA06
TIMOLOL MALEATE
0.25 percent weight/volume
Eye drops, solution
Product subject to prescription which may be renewed (B)
Beta blocking agents, non-selective; timolol
Marketed
2013-02-15
PACKAGE LEAFLET: INFORMATION FOR THE USER TIMOLOL 0.25% W/V EYE DROPS SOLUTION TIMOLOL 0.5% W/V EYE DROPS SOLUTION Timolol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Timolol is and what it is used for 2. What you need to know before you use Timolol 3. How to use Timolol 4. Possible side effects 5. How to store Timolol 6. Contents of the pack and other information 1. WHAT TIMOLOL IS AND WHAT IT IS USED FOR Timolol Eye Drops contain a substance called timolol which belongs to a group of medicines called beta-blockers. Timolol lowers the pressure in your eye(s). It is used to treat glaucoma, when the pressure in the eye is raised. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TIMOLOL DO NOT USE TIMOLOL EYE DROPS IF: you are allergic (hypersensitive) to timolol, beta-blockers or any of the other ingredients of timolol (see section 6: Contents of the pack and other information) you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough). you have heart problems slow heart beat, disorders of heart rhythm (irregular heart beats) heart failure - “cardiogenic shock” – a serious heart condition caused by very low blood pressure, which may result in the following symptoms: dizziness and lightheadedness, fast pulse rate, white skin, sweating, restlessness,loss of consciousness. If you are not sure whether you sh Citiți documentul complet
Health Products Regulatory Authority 17 April 2020 CRN008L95 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Timolol 0.25% w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Timolol 0.25% w/v Eye Drops Solution contains timolol maleate equivalent to 0.25% w/v solution of timolol with preservative. Also contains Benzalkonium chloride. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye drops solution. Clear, colourless to light yellow, sterile eye drops solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Timolol Eye Drops Solution is a beta-adrenoreceptor blocking agent used topically in the reduction of elevated intra-ocular pressure in various conditions including the following: – patients with ocular hypertension – patients with chronic open-angle glaucoma including aphakic patients – some patients with secondary glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION PosologyRecommended therapy is one drop 0.25% solution in the affected eye twice a day. If clinical response is not adequate, dosage may be changed to one drop 0.5% solution in each affected eye twice a day. If needed, Timolol may be used with other agent(s) for lowering intra-ocular pressure. The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.4 'Special warnings and precautions for use'). Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to Timolol may take a few weeks to stabilise. Provided that the intra-ocular pressure is maintained at satisfactory levels, many patients can then be placed on once-a-day therapy. _Transfer from other agents: _ When another topical beta-blocking agent is being used, discontinue its use after a full day of therapy and start treatment with Timolol the next day with one drop of 0.25% Timolol in each affected eye twice a day. The dosage may be increased to one drop of 0.5% solution in each affected eye twice a day, if the response is not adeq Citiți documentul complet