Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
POLYMYXIN B SULFATE NEOMYCIN SULFATE HYDROCORTISONE
GlaxoSmithKline (Ireland) Limited
POLYMYXIN B SULFATE NEOMYCIN SULFATE HYDROCORTISONE
10000 IU/ML
Ear Drops Suspension
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-03-31
[GlaxoSmithKline Logo] PACKAGE LEAFLET: INFORMATION FOR THE USER OTOSPORIN TM EAR DROPS, SUSPENSION POLYMYXIN B SULPHATE, NEOMYCIN SULPHATE AND HYDROCORTISONE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects,talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1 What Otosporin is and what it is used for 2 What you need to know before you use Otosporin 3 How to use Otosporin 4 Possible side effects 5 How to store Otosporin 6 Further information 1 WHAT OTOSPORIN IS AND WHAT IT IS USED FOR The name of your ear drops is Otosporin TM Ear Drops, Suspension. It is used to treat ear infections and swelling of the external ear. • Otosporin contains three medicines called: polymyxin B sulphate, neomycin sulphate and hydrocortisone. • Polymyxin B sulphate and neomycin sulphate belong to a group of medicines called antibiotics. They kill the germs that can cause ear infections. • Hydrocortisone belongs to a group of medicines called steroids. It helps to reduce the swelling and irritation caused by the infection. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE OTOSPORIN DO NOT USE OTOSPORIN: • if you are allergic (hypersensitive) to polymyxin B sulphate, neomycin sulphate, hydrocortisone or any of the other ingredients of Otosporin (See section 6: Further information) • if you are allergic (hypersensitive) to aminoglycosid Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Otosporin Ear Drops Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Excipients with known effect: Each ml contains 0.005g of cetostearyl alcohol and 0.001g of methyl parahydroxybenzoate (E218). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear drops, suspension A creamy-white aqueous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Otosporin Ear Drops are indicated for the prophylaxis and management of otitis externa due to or complicated by bacterial infection. The use of Otosporin Ear Drops does not exclude concomitant systemic therapy with antibiotics where appropriate (_see_ _Special Warnings and Special Precautions for Use_). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Otosporin Ear Drops are for topical administration into the ear only. Adults: Following cleansing and drying of the external auditory meatus and canal as appropriate, three drops should be instilled into the affected ear three or four times daily. Alternatively, a gauze wick may be introduced into the external auditory canal and kept saturated with the solution; the wick may be left in place for 24 to 48 hours. Soap should not be used for cleansing of the external auditory meatus and canal as it may inactivate the antibiotics. Treatment should not be continued for more than 7 days without medical supervision. Use in children: Otosporin Ear Drops is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Otosporin Ear Drops is not recommended for use in neonates and infants (less than 2 years) (see _4.3 Contraindications _and _4.4 Special Warnings and Special Precautions for Use)._ Us Lugege kogu dokumenti