Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
OXYMETAZOLINE HYDROCHLORIDE
Allergan Pharmaceuticals Ireland
0.025 %w/v
Eye Drops Solution
1984-08-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxylin Liquifilm 0.025% w/v Eye Drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One millilitre contains 0.25mg Oxymetazoline Hydrochloride Excipients: Benzalkonium Chloride 0.04mg/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution A clear, colourless to slightly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxylin is indicated in adults for symptomatic relief of redness due to non-infectious irritation of the conjunctiva. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ 1-2 drops into the eye(s) every 8 hours. _Paediatric population_ The safety and efficacy of Oxylin in children aged <18 years have not been established. No data are available. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute immediately following the instillation of each drop. To avoid contamination, do not let the tip of the dropper touch your eye or anything else. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients. • Patients receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment, since hypertensive crisis may occur. • Patients with uncontrolled hypertension, cardiac irregularities, hyperglycaemia (diabetes mellitus) and hyperthyroidism. • Patients in whom pupillary dilation should be avoided (angle-closure glaucoma or those with critically narrow angles). IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/07/2011_ _CRN 2085725_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Card Leggi il documento completo