国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Timolol maleate
Waymade Healthcare Plc
S01ED01
Timolol maleate
2.5mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000
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, please 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. - Your medicine, Timolol Eye Drops will be referred to as Timolol in this leaflet. 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 The active ingredient timolol belongs to a group of medicines called beta-blockers. Timolol is used to treat raised pressure of eye (intraocular pressure) which occurs in various conditions including glaucoma and ocular hypertension. 2. What you need to know before you use Timolol Do not use Timolol if: l you are allergic (hypersensitive) to timolol ,beta-blockers or any other ingredient of this medicine (see section 6: Content of the pack and other information). l you have now or have had in 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). l you have a slow heart beat, heart problems, heart failure or disorders of heart rhythm (irregular heart beats).“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 should use Timolol talk to your doctor or pharmacist. Warnings and precauti 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Timolol Eye Drops 0.25% w/v 2 QUALITATIVE AND QUANTITTAIVE COMPOSITION Active Ingredient Timolol 2.5 mg/ml (as Timolol maleate 3.4 mg/ml) Excipient(s) with known effect: Benzalkonium chloride 0.10 mg/ml Disodium phosphate dodecahydate 16.72 mg/ml Sodium dihydrogen phosphate dihydrate 3.12 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Clear, colourless to pale yellow, odourless solution, free of visible particulate matter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Timolol is a beta-adrenoceptor blocking agent used topically in the reduction of elevated intra-ocular pressure in various conditions including following: - Patients with ocular hypertension; - Patients with chronic open-angle glaucoma including aphakic patients - Some patient with secondary glaucoma. 4.2 Posology and method of administration Posology Recommended 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 also section 4.4). Intraocular pressure should be reassessed approximately four weeks after starting treatment because response to Timolol eye drops 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 eye drops 0.25% the next day with one drop 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 adequate. When transferring a patient from a single anti-glaucoma agent other 阅读完整的文件