País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
LATANOPROST TIMOLOL MALEATE
Laboratorios Normon S.A.
LATANOPROST TIMOLOL MALEATE
50 /5.0
Eye Drops Solution
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-03-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Latanoprost/Timolol Normon 50 microgram/5.0 mg per ml Eye Drops Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 50 microgram Latanoprost and 6.8 mg Timolol maleate equivalent to 5 mg Timolol. Excipient: Benzalkonium chloride 0.2 mg/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. The solution is a clear, colourless liquid. Osmolality: 280~320 mOsmol/kg pH: 5.0 – 7.0 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. _Method of administration:_ 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. 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. _Paediatric population:_ Safety and effectiveness in children and adolescents has not been established. 4.3 CONTRAINDICATIONS Latanoprost / Timolol Eye drops, solution is contraindicated in patients with: - Reactive airway disease including bronchial asthma or a history of bronchial asthma, Leer el documento completo