País: Israel
Idioma: anglès
Font: Ministry of Health
TIMOLOL AS MALEATE
RAFA LABORATORIES LTD
S01ED01
EYE DROPS, SOLUTION
TIMOLOL AS MALEATE 5 MG/ML
OCULAR
Required
LABORATORIES MERCK,SHARP & DOHME-CHIBRET (MIRABEL), FRANCE
TIMOLOL
TIMOLOL
For the reduction of elevated intraocular pressure may be used in patients with chronic open-angle glaucoma, aphakic glaucoma, some patients with secondary glaucoma and patients with ocular hypertension
2013-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine can be sold under doctor's prescription only TILOPTIC ® 0.5% OPHTHALMIC SOLUTION The ophthalmic solution contains: Timolol (as maleate) 5 mg/ml For a list of inactive ingredients see section 6.1 "What TILOPTIC contains". See also section 2.6 “IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF TILOPTIC”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • This leaflet contains concise information about TILOPTIC. If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. • This medicine is not intended for use in children and infants. 1. WHAT TILOPTIC IS AND WHAT IT IS USED FOR? Timolol lowers the intraocular pressure. TILOPTIC is used to treat glaucoma and to reduce elevated intraocular pressure. THERAPEUTIC GROUP: beta blockers. BEFORE YOU USE TILOPTIC 2. 2.1 DO NOT USE TILOPTIC IF: - you are hypersensitive (allergic) to timolol, beta-blockers or any of the other ingredients of TILOPTIC (for a list of inactive ingredients, see section 6.1). - you are suffering or have suffered in the past from 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 heartbeat - disorders of heart rhythm (irregular heartbeats) - 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 should use TILOPTIC talk to your doctor or pharmacist . 2.2 SPECIAL WARNINGS CONCERNING USE OF TILOPTIC BEFORE STARTING TREATMENT WITH TILOPTIC, TELL YOUR DOCTOR IF you are suff Llegiu el document complet
1 1. NAME OF THE MEDICINAL PRODUCT TILOPTIC® 0.5 % 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ‘Tiloptic’ 0.5% w/v Eye Drops Solution contains timolol maleate equivalent to 0.5% w/v solution of timolol. Excipients with known effect: Benzalkonium chloride 0.10mg/ml Disodium phosphate dodecahydrate 30.42mg/ml Sodium dihydrogen phosphate dihydrate 6.10mg/ml For 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 For the reduction of elevated intraocular pressure may be used in patients with chronic open angle glaucoma, aphakic glaucoma, some patients with secondary glaucoma and patients with ocular hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Recommended therapy is one drop in the affected eye twice a day. If needed, ‘Tiloptic’ 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 4.4 ‘Special warnings and precautions for use’). Intra-ocular pressure should be reassessed approximately four weeks after starting treatment because response to ‘Tiloptic’ 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. 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. _Transfer from other agents _ 2 When another topical beta-blocking agent is being used, discontinue its use after a full day of therapy and start treatment the next day with one drop of ‘Tiloptic’ in each affected eye twice a day. When transferring a patient from a single anti-glaucoma agent other than a topical beta-blocking agent, continue the agent and add one drop of ‘Tiloptic’ in each affected eye twice a day. On the following day, d Llegiu el document complet