Package Insert: Information for the User

Aceoto 3 mg/ml Ophthalmic Drops in Solution

Ciprofloxacin

Read this entire package insert carefully before starting to use this medicationbecause it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the adverse effects are not listed in this package insert. See section 4.

Ciprofloxacin is an antibiotic that belongs to the group of antibiotics known as fluoroquinolones.

It is indicated for external otitis (infection of the outer ear) caused by microorganisms sensitive to ciprofloxacin.

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

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.

Use of Aceoto with food, drinks, and alcohol

No information is available.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No clinical data is 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

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

Follow exactly the administration instructions for Aceoto 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 treatment duration 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 pulling the eardrum, so that the air bubbles are replaced by the medication.

If you use more Aceoto than you should

No information is available regarding overdosing. In case of accidental ingestion, instead of topical application, routine measures should be taken, such as gastric lavage, and seek medical attention as soon as possible.

In case of overdose or accidental ingestion,consult your doctor or pharmacist or call the Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Aceoto

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Aceoto may produce adverse effects, although not all people will experience them.

Rare: may affect up to 1 in 100 people

Itching at the application site (pruritus) may occur, which resolves upon discontinuation of the medication.

Reporting 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 prospectus. You may also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use Aceoto after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication must be disposed of one month after opening

Medicines should not be thrown down the drain or in the trash. Deposit the containers and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. In this way, you will help protect the environment.

Composition of Aceoto

The active principle 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.

Appearance of the product and contents of the packaging

Preconditioned solution in a transparent polyethylene container of 10 ml provided with a dropper and a pre-closed cap.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

Zambon S.A.U.

Maresme 5. Pol. Can Bernades-Subirà

08130 – Sta. Perpètua de Mogoda - Barcelona

Manufacturer responsible

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)

Last review date of this prospectus:June 1995

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.