CETRAXAL OTIC 3 mg/ml EAR DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Cetraxal Otic 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 pack:

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

1. What Cetraxal Otic is and what it is used for

Cetraxal Otic 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.

2. What you need to know before you use Cetraxal Otic

Do not use Cetraxal Otic:

• if you are allergic to ciprofloxacin or other quinolones or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cetraxal Otic.

Other medicines and Cetraxal Otic

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

Using Cetraxal Otic with food, drinks, and alcohol

Not described.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

No clinical data are available. However, given the route of administration, it is unlikely that this medicine will affect your ability to drive or use machines.

Cetraxal Otic contains parahydroxybenzoates

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

3. How to use Cetraxal Otic

Follow exactly the administration instructions for Cetraxal Otic 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 tractioning the pinna, so that when the air bubbles come out, they are replaced by the medication.

If you use more Cetraxal Otic than you should

No information is available on overdosing. 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 medicine and the amount ingested.

If you forget to use Cetraxal Otic

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cetraxal Otic can cause side effects, although not everybody gets them.

Uncommon: may affect up to 1 in 100 people

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

Reporting of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetraxal Otic

Keep out of the sight and reach of children.

Do not use Cetraxal Otic after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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 protect the environment.

6. Further information

Composition of Cetraxal Otic

• 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 and packaging

Solution packaged in a 10 ml opaque polyethylene container with a dropper and sealed cap.

Marketing authorisation holder

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

08950 Esplugues de Llobregat

Barcelona - Spain

Manufacturer

Laboratorios Salvat, S.A.

C/Gall, 30-36 – 08950

Esplugues de Llobregat

Barcelona – Spain

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