Страна: Мальта
Язык: английский
Источник: Medicines Authority
CIPROFLOXACIN, HYDROCORTISONE
Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland
S02CA03
CIPROFLOXACIN 2 mg/ml HYDROCORTISONE 10 mg/ml
EAR DROPS, SUSPENSION
CIPROFLOXACIN 2 mg/ml HYDROCORTISONE 10 mg/ml
POM
OTOLOGICALS
Authorised
2005-09-27
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CIPROXIN HC OTIC*, 2MG/ML AND 10MG/ML, EAR DROPS SUSPENSION CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Ciproxin HC Otic* is and what is it used for 2. What you need to know before you use Ciproxin HC Otic* 3. How to use Ciproxin HC Otic* 4. Possible side effects 5. How to store Ciproxin HC Otic* 6. Contents of the pack and other information 1. WHAT CIPROXIN HC OTIC* IS AND WHAT IS IT USED FOR Ciproxin HC Otic* ear drops suspension contains two active ingredients, a steroidal anti-inflammatory and an antibacterial antibiotic. Ciproxin HC Otic* ear drops suspension is a white to off-white liquid, supplied as ear drops in 10 ml glass bottles. This medication is used to treat acute otitis externa in cases where the ear drum is not perforated, in adults and children older than 2 years. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CIPROXIN HC OTIC* Before prescribing this medication, your doctor should have examined your ears to ensure that your ear drums are not perforated. Do not use Ciproxin HC Otic* ear drops suspension: − If you are allergic to ciprofloxacin or any other medication of the quinolone group. − If you are allergic to hydrocortisone or any other component of Ciproxin HC Otic* ear drops suspension. − If your ear drum is perforated or damaged. − If you suffer from viral infections of the ear, including varicella virus or herpes simplex virus infections. − If you think Прочитать полный документ
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CIPROXIN* HC OTIC, ear drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml ear drop suspension contains 2.329 mg ciprofloxacin hydrochloride monohydrate equivalent (equivalent to 2 mg ciprofloxacin) and 10mg hydrocortisone. Excipients with known effect: This medicine contains 90 mg Benzyl alcohol in each 10 ml which is equivalent to 9 mg/ml. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Ear drops, suspension. The suspension is opaque and white to off-white. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute bacterial otitis externa, in the absence of perforated tympanic membrane. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For otic use only. Posology: In adults and in children over two years old: instill 3 drops of suspension into the affected ear, twice a day. Duration of treatment: 7 days. Method of administration: Ear drop instillation. Warm the bottle just before use by holding it in the palm of your hand for a few minutes. This will prevent any unpleasant sensation associated with the cold suspension coming into contact with the ear. Shake well before use. With the head tilted, instill the drops into the affected ear. Keep the head tilted on its side for at least 30 seconds to enable the drops to penetrate into the external auditory canal. Repeat, if necessary, in the other ear. Shake before use. Just before use, remove the cap from the bottle and replace it with the measured dropper. CIPROXIN* is ready to use as soon as the dropper is in place. At the end of the course of treatment, the remainder of the bottle should be discarded and should not be kept for reuse. 4.3 CONTRA-INDICATIONS Page 2 of 8 This product SHOULD NEVER BE USED in patients with: - hypersensitivity to ciprofloxacin or other quinolones - hypersensitivity to hydrocortisone or any other ingredient in the suspension - known or suspe Прочитать полный документ