Label: Information for the Patient

Cetraxal plus 3 mg/ml + 0.25 mg/ml eye drops in solutionin single-dose packaging

ciprofloxacin / fluocinolone acetonide

Read the entire 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 what it is used for.

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 use in the ear).Contains:

• Ciprofloxacin, which belongs to the 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.

It is used in adults and in children aged 6 months or older to treat acute otitis externa (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 you worsen or do not improve after completing treatment.

Do not use Cetraxal plus:

• If you are allergic to ciprofloxacin, other quinolones, acetonide 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. Do not ingest, inject, or inhale. Do not apply to the eye.

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

-Inform your doctor if symptoms do not improve before completing the 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 not enough clinical experience on the use of Cetraxal plus in children under 6 months, so consult with 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.

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 acetonide fluocinolone.

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

Care should be taken when administering Cetraxal plus to a breastfeeding woman, as it is not known if 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 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 the contents of one single-use package 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:

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

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 visit the nearest medical service.

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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If you experience any of the following symptoms, 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, fungal infection of the external ear, 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.

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.

Store below 86°F. Store the aluminum foil pouch in the original packaging to protect it from light. Dispose of the aluminum foil pouch after 7 days of opening.

After opening the single-dose package: use immediately and dispose of the single-dose package after administration.

Medicines should not be thrown away through drains or in the trash. Deposit the packaging and unused medicines atthe pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Compositionof Cetraxal plus

• The active ingredients 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. Each single-dose container (0.25 ml) contains 0.75 mg of ciprofloxacin and 0.0625 mg of acetonide of fluocinolone.

• The other components are polisorbate 80, glycerin, povidone, and purified water.

Appearance of the product and contents of the container

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Salvat, S.A.

C/ Gall 30-36

08950 - Esplugues de Llobregat

Barcelona (Spain)

This leaflet has been approved in: August 2022

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

AlemaniaInfectoCiproCort 3 mg/ml + 0.25 mg/ml Ohrentropfen, Lösung im

Einzeldosisbehältnis

DinamarcaCetraxal Comp ukonserveret

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

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

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

FranciaCETRAXAL 3mg + 0.25mg par ml, solution pour instillation auriculaire en récipient unidose

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

NoruegaCetraxal Comp 3 mg/ml + 0.25 mg/ml øredråper, oppløsning i

endosebeholder

PoloniaCetraxal plus

PortugalCetraxal Duo 3 mg/ml + 0.25 mg/ml gotas auriculares, solução em

recipienteunidose

Reino UnidoCetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops solution in single-dose container

República ChecaInfalin duo

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

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

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

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