Aceoto 3 mg/ml otic solution drops
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Aceoto 3 mg/ml ear drops solution
Ciprofloxacin
Read the entire 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Aceoto is and what it is used for
- What you need to know before using Aceoto
- How to use Aceoto
- Possible adverse effects
- How to store Aceoto
- Contents of the pack and other information
1. What Aceoto is and what it is used for
Aceoto is an antibiotic belonging to a group of antibiotics known as fluoroquinolones.
It is indicated for the treatment of external otitis (infection of the outer ear) caused by microorganisms sensitive to ciprofloxacin.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.
It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
2. What you need to know before starting to use Aceoto
Do not use Aceoto
If you are allergic to ciprofloxacin or other quinolones, or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Aceoto.
Other medicines and Aceoto
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Use of Aceoto with food, drinks, and alcohol
Not described.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No clinical data are available on this issue. However, due to the route of administration, it is unlikely that this medicine will affect your ability to drive or operate machinery.
Aceoto contains parahydroxybenzoates
May cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
3. How to use Aceoto
Follow exactly the instructions for the administration of Aceoto as given by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose is 4-6 drops instilled into the external auditory canal every 8 hours. The duration of treatment will be 7 to 8 days.
If the auditory canal is narrow, in order to allow the medication to reach the eardrum, displace the canal inferiorly and then pull on the auricle so that the air bubbles escaping are replaced by the medication.
If you use more Aceoto than you should
There is no available information regarding overdose. In case of accidental ingestion instead of topical application, routine measures should be taken, such as gastric lavage, seeking medical attention as soon as possible.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number (91) 562 04 20, indicating the medication and the amount ingested.
If you forget to use Aceoto
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Aceoto may produce adverse effects, although not everyone experiences them.
Uncommon: may affect up to 1 in 100 people
Itching at the site of application (pruritus) may occur, which resolves upon discontinuation of treatment.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aceoto
Keep out of the sight and reach of children.
Do not use Aceoto after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine must be discarded one month after opening.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Aceoto
The active substance is ciprofloxacin.
The other components are: lactic acid, povidone, anhydrous glucose, propylene glycol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), hydrochloric acid, purified water.
Nature of the product and pack contents
Solution packed in a 10 ml opaque polyethylene container with a dropper and sealing cap.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zambon S.A.U.
Maresme 5. Pol. Can Bernades-Subirà
08130 – Sta. Perpètua de Mogoda - Barcelona
Manufacturer
LABORATORIOS SALVAT, S.A.
Gall, 30-36
08950 Esplugues de Llobregat – Barcelona
or
Pharmaloop, S.L.
C/Bolivia, 15 – Polig.Industrial Azque
28806 Alcalá de Henares,
Madrid (Spain)
Date of the most recent revision of this leaflet: June 1995
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.