Држава: Малта
Језик: Енглески
Извор: Medicines Authority
ciprofloxacin 2 mg/ml, hydrocortisone 10 mg/ml
Alcon Cusi S.A.
S02CA03
ciprofloxacin, hydrocortisone
ear drops, suspension
Authorised
2005-09-27
Page 1 of 4 READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICATION. Do not discard this leaflet. You may need to read it again. If you have any doubt, consult your physician or pharmacist. This medication has been prescribed only for you. Do not give it to others. It can be harmful if used by others, even if they have the same symptoms. CONTENTS OF THIS LEAFLET: 1. What is CIPROXIN HC OTIC and what is it used for 2. Before using CIPROXIN HC OTIC 3. How to use CIPROXIN HC OTIC 4. Possible adverse effects 5. Storage of CIPROXIN HC OTIC CIPROXIN HC OTIC* EAR DROPS SUSPENSION THE ACTIVE INGREDIENTS ARE ciprofloxacin (hydrochloride) 2 mg/ml and hydrocortisone 10 mg/ml. THE OTHER COMPONENTS (EXCIPIENTS) ARE polysorbate 20, sodium acetate, glacial acetic acid, benzyl alcohol, lecithin, sodium chloride, polyvinyl alcohol and purified water. THE MARKETING AUTHORIZATION HOLDER AND MANUFACTURER IS: ALCON CUSÍ, S.A. c/ Camil Fabra, 58 08320 EL MASNOU - Barcelona SPAIN 1. WHAT IS CIPROXIN HC OTIC EAR DROPS SUSPENSION AND WHAT IS IT USED FOR CIPROXIN HC OTIC EAR DROPS SUSPENSION contains two active ingredients, a steroidal antiinflammatory 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. BEFORE USING CIPROXIN HC OTIC EAR DROPS SUSPENSION 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 Прочитајте комплетан документ
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. 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. Page 1 of 10 _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 This product SHOULD NEVER BE USED Прочитајте комплетан документ