PACKAGE LEAFLET: INFORMATION FOR THE USER. <invented name> 1 mg Ear drops, solution Ciprofloxacin

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1 PACKAGE LEAFLET: INFORMATION FOR THE USER <invented name> 1 mg 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 your 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 <invented name> is and what it is used for 2. What you need to know before you use <invented name> 3. How to use <invented name> 4. Possible side effects 5. How to store <invented name> 6. Contents on the pack and other information 1. What is <Invented name> and what it is used for The active substance of <invented name> is ciprofloxacin an antibiotic belonging to an antibacterial group better known as quinolones. Ciprofloxacin prevents growth of certain microorganisms responsible for causing infections. It only works with specific strains of bacteria. <invented name> is used for the topical treatment of the following bacterial ear infections: chronic suppurative otitis media and acute otitis externa. 2. What you need to know before you use <Invented name> Do not use <invented name> If you are allergic (hypersensitive) to ciprofloxacin, to other quinolones or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or your pharmacist before using <invented name> - If you experience an allergic reaction to <invented name> you should stop the treatment and tell your doctor. Allergic reactions occur uncommonly and serious reactions occurs rarely (see section 4 in this leaflet). - Prolonged treatment with this medicinal product may cause overgrowth of resistant organisms. Tell your doctor if you do not experience an improvement in your otitis. 1

2 - If you have a perforated eardrum (the membrane which separates the outer ear from the middle ear), the medicine may enter the oral cavity. - If your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking ciprofloxacin. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds. Children There is no information on the use of <invented name> in children under the age of 2, therefore this medicine is not recommended in this age group. Other medicines and <invented name> Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. <invented name> should not be administered together with other medicines via the auricular route (through the ear). Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. It is preferable to avoid the use of <invented name> during pregnancy. Tell you doctor if you are planning to get pregnant. Do not take <invented name> during breast feeding because ciprofloxacin is excreted in breast milk and cab be harmful four your child. Driving and using machines Among the side effects described with this medicine are vertigo (sensation of dizziness which may be accompanied by feeling unwell, nausea and vomiting, etc.) and headache (see section 4). Therefore make sure you know how you react to <invented name> before driving a vehicle or operating machinery. If in doubt, talk to your doctor. 3. How to use <Invented name> For children over the age of 2, adolescents and adults: Follow the <invented name> administration instructions exactly as your doctor has told you. Your doctor will explain to you exactly how much <invented name> you will be given as well as how often and for how long. This will depend on the type of infections you have and how serious it is. <invented name> should be administered only via the auricular route (through the ear). The normal dose is as follows: Acute otitis externa: 1 mg (one single-dose container of 0.5 ml) every 12 hours for 7 days. Chronic suppurative otitis media: 1 mg (one single-dose container of 0.5 ml) every 12 hours for 10 days. The dose for patients over 65 is the same. You should check with your doctor or pharmacist if you are not sure. For correct administration, follow the instructions below: 1.- Remove one single-dose from the strip. 2

3 2.- Check that the single-dose is undamaged. 3.- Hold the single-dose between the thumb and index finger of one hand. Using the thumb and index finger of the other hand, lever the wing section open at the end of the singledose. Do not twist to break it. 4.- Remove the wing section. 5.- In order to apply the solution correctly, lie down with the infected ear facing the ceiling. 6.- To make it easier for the ear solution to enter the ear, hold the top part of the ear and pull it back. In this position, empty the contents of the container by pressing sometimes the single-dose. The amount of solution inside the unidose container guarantees the correct application of the dosage (0.5ml), even though some quantity may remain inside the unidose after emptying it. 7.- Once the ear solution has been applied, press the raised part of the ear located just in front of the outer ear canal (called the tragus) several times, so that the ear solution is distributed inside the ear. 8.- Remain in this position for about 5 minutes. 9.- Sit up and bend your head to the side of the treated ear to remove excess ear solution. Do not plug the ear with cotton wool or similar material, as it may lengthen the infection 3

4 If you use more <invented name> than you should In the event of overdose or accidental ingestion, inform your doctor or pharmacist. If you forget to use <invented name> Do not use a double dose to make up for a forgotten dose. If you stop using <invented name> It is important that you finish the course of treatment even if you begin to feel better after a few days. If you stop using this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience a severe allergic reaction and any of the following happen, stop taking ciprofloxacin immediately and tell your doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, rash or hives, large fluidfilled blisters, sores and ulceration. Common side effects (may affect up to 1 in 10 people): growth of germs resistant to this medicine in the ear. Uncommon side effects (may affect up to 1 in in 100 people): dizziness and headache. Localised itching, a burning or stinging sensation and pain at the site of administration may also occur. Rare side effects (may affect up to 1 in 1000 people): allergic reactions which may affect the whole body. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below. By reporting side effects you can help provide more information on the safety of this medicine. Deutschland Bundesinstitut für Arzneimittel und Medizinprodukte Abt. Pharmakovigilanz Kurt-Georg-Kiesinger Allee 3 D Bonn Website: Ελλάδα Εθνικός Οργανισμός Φαρμάκων Μεσογείων 284 GR Χολαργός, Αθήνα Τηλ: /337 Φαξ: Ιστότοπος: 4

5 Österreich Bundesamt für Sicherheit im Gesundheitswesen Traisengasse WIEN ÖSTERREICH Fax: + 43 (0) Website: 5. How to store <Invented name> Keep this medicine out of the sight and reach of children. Store the single-doses in the original package in order to protect from light. Do not use <invented name> after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Contents of the pack and other information What <invented name> contains - The active substance is ciprofloxacin. Each 0.5 ml single-dose container contains 1 mg of ciprofloxacin (as hydrochloride). - The other ingredients are glycerol, polysorbate 20, sodium acetate, acetic acid, methylcellulose (E 461), sodium hydroxide or hydrochloric acid and water for injection. What <invented name> looks like and contents of the pack <invented name> ear drops, solution (ear drops) is supplied as single-dose containers of 0.5 ml of sterile solution. Each pack contains 20 single-doses. Marketing Authorisation Holder and Manufacturer <To be completed nationally> This medicinal product is authorised in the Member States of the EEA under the following names: Germany PANOTILE CIPRO 1 mg Ohrentropfen, Lösung Greece Droll 1 mg Ωτικές σταγόνες, διάλυμα Austria Otanol 1 mg Ohrentropfen, Lösung This leaflet was last revised in 5

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