Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
LATANOPROST, TIMOLOL
Generics (UK) Limited
S01ED51
LATANOPROST, TIMOLOL
50mcg/ml + 5 Mg/Ml
Eye Drops Solution
Product subject to prescription which may not be renewed (A)
Beta blocking agents
Authorised
2014-09-26
NO. OF COLOURS COLOURS NON-PRINT COLOURS DATE: TIME: EQUATE CMYK WITH DESCRIPTION COMPONENT TYPE AFFILIATE ITEM CODE SUPERCEDED AFFILIATE ITEM CODE TRACKWISE PR NO. MA NO. PACKING SITE/PRINTER SUPPLIER CODE SIGN-OFFS PHARMA CODE SAP NO. VENDOR JOB NO. PROOF NO. CLIENT MARKET KEYLINE/DRAWING NO. BARCODE INFO DIMENSIONS MAIN FONT BODY TEXT SIZE PAGE COUNT 24 SEP 2014 1/2 08:45 LATANOPROST/TIMOLOL MALEATE 0.05MG/ML + 5MG/ML 1X2.5ML LEAFLET 428184 NA 428184 405/70/1 WINTAC TBC 1 BLACK TIMES 9PT 127 X 500 MM TBC NA 231209 4 IRELAND NA NA 1. WHAT LATANOPROST / TIMOLOL IS AND WHAT IT IS USED FOR Latanoprost / Timolol contains two active substances: 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. Latanoprost / Timolol is used to reduce the pressure in your eye if you have conditions known as open angle glaucoma or ocular hypertension. Both of these conditions are linked to an increase in the pressure within your eye, which may eventually affect your eyesight. Your doctor will usually prescribe you Latanoprost / Timolol when other medicines have not worked adequately. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST / TIMOLOL Latanoprost / Timolol can be used in adult men and women (including the elderly). Children and adolescents Latanoprost/Timolol is not recommended for children or adolescents less than 18 years of age. DO NOT USE LATANOPROST / TIMOLOL: - if you are allergic to latanoprost or timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6). - if you have now or have had in the past respiratory problems such as asthma or severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Latanoprost/Timolol 50 micrograms/ml + 5mg/ml eye drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms of latanoprost and 6.83 mg of timolol maleate (equivalent to 5 mg of timolol). One drop of the solution contains approximately 1.5 micrograms latanoprost and 150 micrograms timolol. Excipient with known effect: Each ml eye drops solution contains 0.2 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution A clear, colourless, aqueous solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Latanoprost/Timolol is indicated for the reduction of intraocular pressure (IOP) in adults 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 _Recommended dosage for 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 Latanoprost / Timolol in children and adolescents has not yet been established. Method of administration Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. 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 activi Leggi il documento completo