Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Ciprofloxacin hydrochloride
Novartis Ireland Limited
S02AA; S02AA15
Ciprofloxacin hydrochloride
3 milligram(s)/millilitre
Ear drops, solution
Product subject to prescription which may not be renewed (A)
Antiinfectives; ciprofloxacin
Marketed
2006-02-03
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CILOXAN® 3 MG/ML EAR DROPS, SOLUTION ciprofloxacin 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 Ciloxan is and what it is used for 2. What you need to know before you use Ciloxan 3. How to use Ciloxan 4. Possible side effects 5. How to store Ciloxan 6. Contents of the pack and other information 1. WHAT CILOXAN IS AND WHAT IT IS USED FOR Ciloxan contains CIPROFLOXACIN , a QUINOLONE ANTIBIOTIC that is effective against many of the types of germs that cause bacterial infection in your ear(s). It is used to treat acute infections of the outer ear (otitis externa or “swimmer’s ear”) in adults and children aged 1 year and above. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CILOXAN DO NOT USE CILOXAN - If you are ALLERGIC to ciprofloxacin or any other quinolones or to any of the other ingredients of this medicine (listed in Section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Ciloxan. - Only use CILOXAN in your ears. - If you notice the first signs of a skin rash or any other allergic reaction, including hives, itching or breathing problems, stop treatment and immediately contact your doctor. If you have a serious allergic reaction then you may need emergency treatment. - Avoid EXCESSIVE SUNLIGHT while using Ciloxan. - As with any antibiotic, use of Ciloxan for a long time may lead to other infections. If your symptoms get worse or suddenly return, tell your doctor. - If you feel pain, swelling or inflammation of the tendons Lees het volledige document
Health Products Regulatory Authority 22 August 2022 CRN00D481 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciloxan 3 mg/ml ear drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 3mg ciprofloxacin as ciprofloxacin hydrochloride. Excipient(s) with known effect: one ml of solution contains 0.06mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear drops, solution. Clear, colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults and Children 1 year and above Ciloxan is indicated for acute otitis externa due to susceptible strains of bacterial species shown to be responsive to ciprofloxacin as listed in section 5.1. Use should be under the supervision of a specialist ENT service having the facilities for regular monitoring of clinical and microbiological effects during and after administration. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: The dose is 4 drops of Ciloxan in the ear canal twice daily for adults. For patients requiring use of an otowick, the dose can be doubled for the first administration only (i.e., 8 drops for adult patients). Use in elderly No dosage alteration in patients 65 years of age or above is necessary. Paediatric population The dose is 3 drops of Ciloxan in the ear canal twice daily for children 1 year of age and older. For patients requiring use of an otowick, the dose can be doubled for the first administration only (i.e., 6 drops for paediatric patients). The safety and efficacy in paediatric patients below 1 year of age have not been established. Use in hepatic and renal impairment Ciloxan has not been studied in patients with hepatic or renal impairment and is therefore not recommended in such patients. Method of administration For otic use only. AFTER CAP IS REMOVED, IF TAMPER EVIDENT SNAP COLLAR IS LOOSE, REMOVE BEFORE USING PRODUCT. The user s Lees het volledige document