Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LATANOPROST TIMOLOL MALEATE
PCO Manufacturing
50 + 5
Ear Drops Solution
2011-04-08
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. Excipient: Contains benzalkonium chloride For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye Drops, Solution _Product imported from Greece:_ The solution is a clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 _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. _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. _Use in children and adolescents:_ Safety and effectiveness in children and adolescents has not been established. 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. Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock. Hypersensitivity to the active substances or to any of the excipients. IRISH MEDICINES BOARD _____________ Read the complete document