Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Naphazoline hydrochloride
Elara Pharmaservices Europe Limited
S01GA; S01GA01
Naphazoline hydrochloride
0.012 percent weight/volume
Eye drops, solution
Sympathomimetics used as decongestants; naphazoline
Marketed
1983-04-01
Patient Information Leaflet Murine Irritation & Redness Relief 0.012% w/v Eyedrops naphazoline hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER MURINE IRRITATION & REDNESS RELIEF 0.012% W/V EYE DROPS NAPHAZOLINE HYDROCHLORIDE Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any of the side effects, talk to your pharmacist or doctor. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 24 hours. WHAT IS IN THIS LEAFLET 1. What MURINE Irritation & Redness Relief is and what it is used for 2. What you need to know before you take MURINE Irritation & Redness Relief 3. How to use MURINE Irritation & Redness Relief 4. Possible side effects 5. How to store MURINE Irritation & Redness Relief 6. Contents of the pack and other information 1. WHAT MURINE IRRITATION & REDNESS RELIEF IS AND WHAT IT IS USED FOR MURINE Irritation & Redness Relief is an eye drop solution. It is used to clear redness and soothe eyes which have been irritated by, for example, dusty atmospheres, wind, swimming, smoke, air pollutants, or close work such as reading and computer use. This medicine contains the active ingredient naphazoline hydrochloride which belongs to the group of medicines called local vasoconstrictors which act by narrowing the blood vessels in the eye, thereby reducing redness and swelling. MURINE Irritation & Redness Relief is fast acting and has a long lasting action. You must talk to a doctor if you do not feel better or if you feel worse after 24 hours. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MURINE IRRITATION & REDNESS RELIEF DO NOT USE: • if you are allergic to naphazoline hydrochloride or to any of the Baca dokumen lengkap
Health Products Regulatory Authority 20 September 2023 CRN00DM0M Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Murine irritation & redness relief, 0.012% w/v, eye drops solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Actives Naphazoline Hydrochloride 0.012 % w/v. Excipients with known effect: Contains Benzalkonium Chloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye Drops solution (eye drops). A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For temporary symptomatic relief of redness of the eye due to minor eye irritations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults and Children 12 years and over: The recommended dosage is one or two drops into each eye two or three times daily. This product is for intermittent or occasional use only (see section 4.4). Paediatric Population The safety and efficacy of Murine in children aged 0 to 12 years have not been established. No data are available. Method of Administration: For ocular use If other eye drops/ointments are additionally being used, an interval of approximately 15 minutes should be observed between the doses and any eye ointment should always be applied last (see section 4.5). 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Murine is contraindicated in subjects with: angle-closure glaucoma, a narrow chamber angle (at risk for acute glaucoma), previous attacks of acute glaucoma due to a narrow chamber angle, iritis or corneal damage. This product must not be used prior to peripheral iridectomy in eyes susceptible to angle closure because mydriatic action may precipitate angle block. Do not take if you are suffering from serious eye disease or have had previous eye surgery. Do not use while taking monoamine oxidase inhibitors or within 14 days of stopping this medication (see section 4.5). Use in patients with contact lenses. Not to be used in children younger than 12 years of age. Baca dokumen lengkap