Label: information for the user

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

Ciprofloxacin / Fluocinolone acetonide

Read this label carefully before starting to use this medication, because it contains important information for you.

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

1. What is Cetraxal plus and how it is used.

2. What you need to knowbefore starting to use Cetraxal plus

3. How to use Cetraxal plus

4. Possible adverse effects

5. Storage of Cetraxal plus

6. Contents of the package and additional information

Cetraxal Plus is an otic solution (for the ear). It contains:

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

Ciprofloxacin acts by eliminating bacteria that cause infections,

• and, fluocinolone acetate, 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 in children 6 months of age and older to treat acute external otitis (outer ear infection) and acute otitis media (middle ear infection) with tympanostomy tubes (ear tubes) of bacterial origin.

You should consult a doctor if you worsen or do not improve after completing treatment.

No use Cetraxal Plus:

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

• If you have an ear infection caused by a virus or a fungus.

Warnings and Precautions

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

-If symptoms of urticaria (itching) or skin rash or any other allergic symptom (such as sudden swelling of the face, throat, or eyelids, difficulty breathing) occur once treatment has been initiated, discontinue the medication immediately and consult your doctor. Severe hypersensitivity reactions may require immediate emergency treatment.

inmediato de urgencia.

-Consult your doctor if symptoms do not improve before completing treatment.

Like other antibiotics, infections may 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 insufficient clinical experience on the use of Cetraxal Plus in children under 6 months, so consult your doctor before administering this medication to your child if they are this age.

Use of Cetraxal Plus with other medications:

Inform your doctor or pharmacist if you are taking/using, have taken/used recently, or may need to take/use any other medication, including those acquired without a prescription.

Cetraxal Plus should not be used with other medications administered through the ear.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, or believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Caution should be exercised when administering Cetraxal Plus to a breastfeeding woman, as it is not known whether Cetraxal Plus is excreted through breast milk.

Driving and operating machinery:

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.

Cetraxal Plus is intended to be administered in the ear only (otic use). Follow exactly the administration instructions of this medication indicated by your doctor.In case of 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 must wash their hands beforehand.

1. Keep your head inclined to the side of the affected ear for approximately 1 minute to allow the medication to enter the inner ear.

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

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

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

If you use more Cetraxal Plus than you should

No symptoms related to overdose are known.

In case of overdose or accidental ingestion, report to 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 Cetraxal Plus

Do not use a double dose to compensate for the missed doses. Simply continue with your next dose.

If you interrupt treatment with 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 indicated by your doctor, even if symptoms improve. If you stop using this medication prematurely, the infection may not disappear, and symptoms may recur or worsen. Resistance to antibiotics may also occur.

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

Like all medications, Cetraxal plus may produce adverse effects, although not everyone will experience 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, rashes, or hives, sores, ulcers.

Frequent: may affect up to 1 in 10 people

Ear effects:Discomfort,Pain,Itching.

General adverse effects:Alteration in taste.

Infrequent: may affect up to 1 in 100 people

Ear effects: Ringing, residual medication, blockage of the ear drainage tube, tingling, congestion, hearing loss, skin rash, redness, external ear fungal infection, discharge, inflammation, tympanic membrane disorder, granulation tissue, otitis media in the other ear.

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

Unknown frequency (cannot be estimated from available data):Blurred vision.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly to 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 this medication out of the sight and reach of children.

Store below 30°C.

Do not use this medication 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 discarded one month after opening.Once opened, store below 25°C.

Medications should not be thrown away through drains or in the trash. Dispose of the packaging and medications you no longer need atthe pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cetraxal Plus

• The active principles are ciprofloxacin (as hydrochloride) and acetonide of fluocinolone. Each milliliter of Cetraxal Plus contains 3 mg of ciprofloxacin (as hydrochloride) and 0.25 mg of acetonide of fluocinolone.
• The other components are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), povidone, diethylenglycol monoethyl ether, glycereth-26 (glycerin compound and ethylene oxide), hydrochloric acid (E507)/sodium hydroxide (E524) and purified water.

Appearance of the product and contents of the package

Cetraxal Plus is a transparent solution in the form of ear drops for administration in the ear. It is presented in white opaque plastic bottles with a dropper. Each package contains 10 ml of solution.

Holder of the marketing authorization and

Laboratorios SALVAT, S.A.

C/ Gall 30-36

08950 - Esplugues de Llobregat

Barcelona (Spain)

Responsible for manufacturing

Laboratorios SALVAT, S.A.

C/ Gall 30-36

08950 - Esplugues de Llobregat

Barcelona (Spain)

or

PHARMALOOP S.L.

C/Bolivia, 15 - Polig. Industrial Azque

28806Alcala de Henares, Madrid

Spain

This leaflet was approved in June 2019

This medicine is authorized in the member states of the European Economic Area with the following names:

AustriaInfectoCiproCort 3 mg/ml + 0.25 mg/ml ear drops, solution

GermanyInfectoCiproCort 3 mg/ml + 0.25 mg/ml ear drops, solution

DenmarkCetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution

SlovakiaInfalin duo 3 mg/ml + 0.25 mg/ml ear drops, solution

SpainCetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops in solution

FranceCETRAXAL 3mg + 0.25mg per ml, solution for ear instillation

FinlandCetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution

IcelandCetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution

NorwayCetraxal Comp

PolandCetraxal plus

PortugalCetraxal Duo 3 mg/ml + 0.25 mg/ml ear drops, solution

Czech RepublicInfalin duo 3 mg/ml + 0.25 mg/ml ear drops, solution

RomaniaCexidal 3 mg/ml + 0.25 mg/ml ear drops, solution

SwedenCetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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