CETRAXAL PLUS 3 mg/ml + 0.25 mg/ml OTIC SOLUTION DROPS

Introduction

Package Leaflet: Information for the User

Cetraxal plus 3 mg/ml + 0.25 mg/ml ear drops in solution

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 is Cetraxal Plus and what is it used for

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

• Ciprofloxacin, which belongs to a 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.

Cetraxal Plus is an ear drop solution. It is used in adults and children aged 6 months and older to treat acute external otitis (infection of the outer ear) and otitis media (infection of the middle ear) with tympanostomy tubes (ear tubes) of bacterial origin.

You should consult a doctor if your symptoms worsen or do not improve after completing 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 to the eye.

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

If your symptoms do not improve before completing the treatment, talk to your doctor.

• As with other antibiotics, infections can sometimes be caused by organisms that are not sensitive to ciprofloxacin. In such cases, the 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.

Use of Cetraxal Plus with other medications:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications, including those obtained without a prescription.

The use of Cetraxal Plus with other ear medications is not recommended.

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, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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.

Cetraxal Plus contains:

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

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 6 to 8 drops 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 that the infection does not recur, do not interrupt treatment prematurely, even if you notice improvement in the ear(s).

Administration instructions:

The person administering Cetraxal Plus should wash their hands beforehand.

1. Keep your head tilted towards the affected ear for approximately one minute to allow the medication to enter the ear.

1. Repeat the operation, if necessary, in the other ear.

It is essential that you follow these instructions to achieve a good result with this medication in your ear. Once the medication has been administered in the ear, keeping your head in a vertical position or moving your head too quickly may cause some of the medication to be lost because the drops may fall down your face and not penetrate the inner part of the ear canal.

Keep the bottle until the end of the treatment. Do not store it for later use.

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 call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 very important 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 your symptoms may recur or even worsen. Resistance to antibiotics may also occur.

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

4. Possible side effects

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

If you experience a severe allergic reaction and any of the following symptoms appear, discontinue treatment with this medication and consult your doctor immediately: swelling of hands, feet, ankles, face, lips, mouth, or throat, difficulty swallowing or breathing, rash, or hives.

Common: may affect up to 1 in 10 people

Ear effects:Discomfort, pain, itching.

General side effects:Alteration in taste.

Uncommon: may affect up to 1 in 100 people

Ear effects: Ringing, residue of medication, blockage of the ear drainage tube, tingling, congestion, reduced hearing, skin rash, redness, external ear fungal infection, 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 Health 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 Cetraxal plus

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

Store below 30°C.

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.

This medication should be discarded one month after opening. Once opened, store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cetraxal Plus

• The active ingredients 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.
• The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), povidone, diethylene glycol monoethyl ether, glycereth-26 (a compound of glycerin and ethylene oxide), hydrochloric acid (E507)/sodium hydroxide (E524), and purified water.

Appearance and packaging of the product

Cetraxal Plus is a clear solution in the form of ear drops. It comes in white opaque plastic bottles with a dropper. Each pack contains 10 ml of solution.

Marketing authorization holder and

Laboratorios SALVAT, S.A.

C/ Gall 30-36

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 Alcala de Henares, Madrid

Spain

This leaflet was approved in June 2019.

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

Austria InfectoCiproCort 3 mg/ml + 0.25 mg/ml Ohrentropfen, Lösung

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

Denmark Cetraxal Comp 3 mg/ml + 0.25 mg/ml Øredråber, opløsning

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

Spain Cetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops in solution

France CETRAXAL 3mg + 0.25mg par ml, solution pour instillation auriculaire

Finland Cetraxal Comp 3 mg/ml + 0.25 mg/ml Korvatipat, liuos

Iceland Cetraxal Comp 3 mg/ml + 0.25 mg/ml Eyrnadropar, lausn

Norway Cetraxal Comp

Poland Cetraxal plus

Portugal Cetraxal Duo 3 mg/ml + 0.25 mg/ml ear drops, solution

Czech Republic Infalin duo 3 mg/ml + 0.25 mg/ml ušní kapky, roztok

Romania Cexidal 3 mg/ml + 0.25 mg/ml Picaturi auriculare, solutie

Sweden Cetraxal Comp 3 mg/ml + 0.25 mg/ml Örondroppar, lösning

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/