País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Framycetin sulfate; Gramicidin; Dexamethasone
Sanofi-Aventis Ireland Limited T/A SANOFI
S03CA; S03CA01
Framycetin sulfate; Gramicidin; Dexamethasone
0.5 %w/v+0.005 %w/v+0.05 percent weight/volume
Ear/eye drops, solution
Product subject to prescription which may not be renewed (A)
Corticosteroids and antiinfectives in combination; dexamethasone and antiinfectives
Not marketed
1977-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER SOFRADEX EAR/EYE DROPS Framycetin sulphate 5mg/ml Gramicidin 0.05mg/ml Dexamethasone sodium metasulphobenzoate 0.5mg/ml IS THIS LEAFL ET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leafl et. You may need to read it again • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours • If any of the side effects gets serious, or if you notice any side effects not listed in this leafl et, please tell your doctor or pharmacist IN THIS LEAFL ET: 1. What Sofradex Drops are and what they are used for 2. Before you use Sofradex Drops 3. How to use Sofradex Drops 4. Possible side effects 5. How to store Sofradex Drops 6. Further information 1. WHAT SOFRADEX DROPS ARE AND WHAT THEY ARE USED FOR WHAT SOFRADEX DROPS ARE Sofradex Ear/Eye Drops (called Sofradex Drops in this leafl et) contains three medicines called Framycetin sulphate, Gramicidin and Dexamethasone sodium metasulphobenzoate. • Framycetin sulphate and Gramicidin belong to a group of medicines called antibiotics. These work by killing the bacteria that is causing the infection • Dexamethasone sodium metasulphobenzoate. This belongs to a group of medicines called steroids. It works by lowering infl ammation WHAT SOFRADEX DROPS ARE USED FOR IT IS USED IN THE EYE(S) FOR: • Infl ammation in the eye when prevention of bacterial infection is also needed. Signs include sore, red or swollen eyes IT IS USED IN THE EAR(S) FOR: • Infl ammation of the ear canal (otitis externa) 2. BEFORE YOU USE SOFRADEX DROPS DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR IF: You are allergic (hypersensitive) to framycetin sulphate, dexamethasone sodium metasulphobenzoate, gramicidin or any of the other ingredients of Sofradex Drops (listed in Section 6 below) Signs of an allergic reaction include: a rash, Leer el documento completo
Health Products Regulatory Authority 03 December 2019 CRN009FFS Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sofradex Ear/Eye Drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Framycetin Sulphate 0.5 %w/v (5mg/ml), Gramicidin 0.005% w/v (0.05 mg/ml), Dexamethasone sodium metasulphobenzoate equivalent to Dexamethasone 0.05% w/v (0.5 mg/ml). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear/Eye drops, solution. Practically clear, colourless to slightly green-yellow aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _In the eye_ For the short-term treatment of steroid responsive conditions of the eye, when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease. _In the ear_ Otitis externa. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Auricular and Ocular. ADULTS (AND THE ELDERLY) AND CHILDREN _In the eye_ One or two drops applied to each affected eye up to six times daily or more frequently if required. _In the ear_ Two or three drops instilled into the ear three or four times daily. Treatment duration should be short (not exceed 7 days) (see section 4.4). 4.3 CONTRAINDICATIONS Use in patients hypersensitive to the active ingredients. Use in the presence of infections of viral, treponemal, tuberculous or of non-sensitive fungal origin. Use in infants. The product should not be used if there is a perforation of the tympanic membrane (eardrum perforation), as entry into the middle ear could lead to ototoxicity. Use is contraindicated if glaucoma is present or herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Use of topical steroids in the latter condition can lead to extension of the ulcer and marked visual deterioration. Health Products Regulatory Authority 03 December 2019 CRN009FFS Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged use of an anti-infective may result in the development of superinfection due to organisms, Leer el documento completo