CETRAXAL PLUS 3 mg/mL + 0.25 mg/mL OTIC SOLUTION, SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the Patient

Cetraxal plus 3 mg/ml + 0.25 mg/ml ear drops in solution for single-dose container

ciprofloxacin / fluocinolone acetonide

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

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

Cetraxal plus is a solution for otic use (in the ear). It contains:

• Ciprofloxacin, which belongs to the group of antibiotics called fluoroquinolones.

Ciprofloxacin acts by eliminating bacteria that cause infections,

• and fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic properties for the treatment of inflammation and pain.

It is used in adults and children from 6 months of age to treat acute external otitis (infection of the outer ear) and otitis media (infection of the middle ear) of bacterial origin with tympanostomy tubes (drainage tubes).

You should consult a doctor if your symptoms worsen or do not improve after finishing the treatment.

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

Do not use Cetraxal plus:

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

• If you have a viral or fungal ear infection.

Warnings and precautions:

• This medication should only be applied in the ear. It should not be ingested, injected, or inhaled. It should not be applied in the eye.

• If you experience symptoms of urticaria (itching) or skin rash or any other allergic symptom (e.g., sudden swelling of the face, throat, or eyelids, difficulty breathing) after starting treatment, stop the medication immediately and consult your doctor. Severe hypersensitivity reactions may require immediate emergency treatment.

• Tell your doctor if your symptoms do not improve before finishing the treatment. As with other antibiotics, infections can sometimes be caused by organisms that are not sensitive to ciprofloxacin. In such cases, appropriate treatment should be prescribed by your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children:

There is not enough clinical experience with the use of Cetraxal plus in children under 6 months, so you should consult your doctor before administering this medication to your child if they are of this age.

Using Cetraxal plus with other medications:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

It is not recommended to use Cetraxal plus with other ear medications.

Pregnancy, breastfeeding, and fertility:

There are no adequate and well-controlled studies in pregnant women on the teratogenic effects of fluocinolone acetonide.

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.

Caution should be exercised when administering Cetraxal plus to a breastfeeding woman since it is not known whether Cetraxal plus is excreted in breast milk.

Driving and using machines:

Given the characteristics and route of administration of the medication, Cetraxal plus does not affect the ability to drive vehicles or operate hazardous machinery.

3. How to use Cetraxal plus

Cetraxal plus is intended for otic use only (in the ear). Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults and children is the contents of 1 single-dose container, twice a day in the affected ear, for 7 days.

Only administer Cetraxal plus in both ears if your doctor recommends it.

Your doctor will indicate the duration of treatment with Cetraxal plus. To ensure the infection does not recur, do not stop treatment prematurely, even if you notice improvement in the ear(s).

Administration instructions:

It is essential that you follow these instructions to achieve a good result with this medication in your ear.

If you use more Cetraxal plus than you should

The symptoms related to overdose are not known.

In case of overdose or accidental ingestion, inform your doctor or pharmacist or go to the nearest medical service.

If you forget to use Cetraxal plus

Do not use a double dose to make up for forgotten doses. Simply continue with your next dose.

If you stop using Cetraxal plus

Do not stop using Cetraxal plus without consulting your doctor or pharmacist. It is crucial to use these ear drops for the time your doctor has indicated, even if your symptoms improve. If you stop using this medication too soon, the infection may not disappear, and symptoms may recur or worsen. Resistance to antibiotics may also occur.

If you have any further questions on the use of this medication, 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 any of the following symptoms, stop the treatment with this medication and consult your doctor immediately: swelling of hands, feet, ankles, face, lips, mouth, or throat, difficulty swallowing or breathing, rash, blisters, ulcers.

Common: may affect up to 1 in 10 people

Ear effects: Discomfort, pain, itching.

General side effects: Altered taste.

Uncommon: may affect up to 1 in 100 people

Ear effects: Ringing in the ears, medication residue, blockage of the ear drainage tube, tingling, congestion, reduced hearing, skin rash, redness, fungal infection of the outer ear, discharge, inflammation, eardrum disorder, granulation tissue, otitis media in the other ear.

General side effects: Fungal infection (Candida), irritability, crying, dizziness, flushing, headache, vomiting, fatigue.

Frequency not known (cannot be estimated from the available data): Blurred vision.

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 Medicines and Healthcare Products Agency's (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cetraxal plus

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Store below 30°C. Keep the aluminum pouch in the original packaging to protect it from light. Discard the aluminum pouch 7 days after opening.

After opening the single-dose container: use immediately and discard the single-dose container after administration.

Medicines should not be disposed of via wastewater or household waste. Return any unused medication and packaging to your pharmacist. If in doubt, ask your pharmacist how to dispose of unused medication and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cetraxal plus

• The active substances are ciprofloxacin (as hydrochloride) and fluocinolone acetonide.

Each milliliter of Cetraxal plus contains 3 mg of ciprofloxacin (as hydrochloride) and 0.25 mg of fluocinolone acetonide. Each single-dose container (0.25 ml) contains 0.75 mg of ciprofloxacin and 0.0625 mg of fluocinolone acetonide.

• The other ingredients are polysorbate 80, glycerin, povidone, and purified water.

Appearance and packaging of the product

Cetraxal plus is a colorless or slightly yellowish aqueous solution in the form of ear drops in single-dose containers. The single-dose containers are packaged in an aluminum pouch for protection. Each pouch contains 15 single-dose containers.

Marketing authorization holder and manufacturer

Laboratorios Salvat, S.A.

C/ Gall 30-36

08950 - Esplugues de Llobregat

Barcelona (Spain)

This leaflet was approved in: August 2022

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany InfectoCiproCort 3 mg/ml + 0.25 mg/ml Ohrentropfen, Lösung im Einzeldosisbehältnis

Denmark Cetraxal Comp ukonserveret

Slovakia Infalin duo 3 mg/ml + 0.25 mg/ml Ušná roztoková instilácia v jednodávkovom obale

Spain Cetraxal Plus 3 mg/ml + 0.25 mg/ml gotas óticas en solución en envase unidosis

Finland Cetraxal Comp 3 mg/ml + 0.25 mg/ml korvatipat, liuos, kerta-annospakkaus

France CETRAXAL 3mg + 0,25mg par ml, solution pour instillation auriculaire en récipient unidose

Iceland Cetraxal Comp 3 mg/ml + 0.25 mg/ml eyrnadropar, lausn í stakskammtaíláti

Norway Cetraxal Comp 3 mg/ml + 0.25 mg/ml øredråper, oppløsning i endosebeholder

Poland Cetraxal plus

Portugal Cetraxal Duo 3 mg/ml + 0.25 mg/ml gotas auriculares, solução em recipiente unidose

United Kingdom Cetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops solution in single-dose container

Czech Republic Infalin duo

Romania Cexidal 3 mg/0.25 mg/ml picaturi auriculare, solu?ie în recipient unidoza

Sweden Cetraxal Comp 3 mg/ml + 0.25 mg/ml örondroppar, lösning i endosbehållare

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/