ACEOTO 3 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Aceoto 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.

Contents of the Package Leaflet

1. What is Aceoto and what is it used for
2. What you need to know before you use Aceoto
3. How to use Aceoto
4. Possible side effects
5. Storage of Aceoto
6. Contents of the pack and further information

1. What is Aceoto and what is it used for

Aceoto is an antibiotic that belongs to the group of antibiotics called fluoroquinolones.

It is indicated for 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 the flu or the common cold.

It is important that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medications via wastewater or trash.

2. What you need to know before you use Aceoto

Do not use Aceoto

If you are allergic to ciprofloxacin or other quinolones or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aceoto.

Other medications and Aceoto

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication.

Use of Aceoto with food, beverages, 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 medication.

Driving and using machines

No clinical data are available. However, given the route of administration, it is unlikely that this medication will affect your ability to drive vehicles or operate machinery.

Aceoto contains parahydroxybenzoates

May cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

3. How to use Aceoto

Follow the instructions for administration of Aceoto exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose is 4-6 drops instilled into the external auditory canal, every 8 hours. The duration of treatment will be 7 to 8 days.

In the case of a narrow auditory canal, the medication is made to reach the eardrum by displacing the canal from its lower part and then tractioning the pinna, so that when the air bubbles come out, they are replaced by the medication.

If you use more Aceoto than you should

No information is available regarding overdose. In case of accidental ingestion, instead of topical application, routine measures should be taken, such as gastric lavage, and you should go to a medical center as soon as possible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone (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 forgotten doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Aceoto can cause side effects, although not everyone gets them.

Uncommon: may affect up to 1 in 100 people

Itching at the site of application (pruritus) may occur, which subsides when the medication is discontinued.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Aceoto

Keep out of sight and reach of children.

Do not use Aceoto after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

This medication must be discarded one month after opening.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Aceoto

The active ingredient is ciprofloxacin.

The other ingredients are: lactic acid, povidone, anhydrous glucose, propylene glycol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), hydrochloric acid, purified water.

Appearance of the product and pack contents

Solution packaged in a 10 ml opaque polyethylene container with a dropper and sealed 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 last revision of this leaflet:June 1995

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.