Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
MEPYRAMINE MALEATE PHENYLEPHRINE HYDROCHLORIDE
Allergan Pharmaceuticals Ireland
0.12; 0.1 %w/v
Eye Drops Solution
1982-09-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PREFRIN-A Topical Ophthalmic Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see 6.1 3 PHARMACEUTICAL FORM Eyedrops, solution Topical, sterile ophthalmic solution A clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PREFRIN-A is used in the symptomatic relief to eyes affected with allergy/inflammation/irritation. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Adults only: one to two drops may be repeated 3 to 4 hourly. Method of Administration: topical into the conjunctival sac. 4.3 CONTRAINDICATIONS Use in patients with a known hypersensitivity to any of the active ingredients. Use in patients with narrow angle glaucoma, or with contact lenses. Use in the presence of infections, foreign bodies or where irritation is severe. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Topical antihistamines are potential sensitizers and use may produce a local sensitivity reaction. Use with caution on an inflamed eye, as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva. The puncta should be depressed after instillation of drops to reduce drainage through the nasolacrimal duct to the oral and nasal mucosa. If red eye persists, discontinue use and consult the eye care specialist. Active Ingredient Phenylephrine hydrochloride 0.12 %w/v Mepyramine maleate 0.10 %w/v IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 24/10/2005_ _CRN 2016030_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Phenylephrine may increase the activity of: Local anaesthetics Adrenergic blockers Monoamine oxidase inhibitors Tricyclic antidepressants Phenylephrine may decrease the activity of: Local anae Lire le document complet