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

Spain
Brand name Cetraxal Plus 3 mg/ml + 0.25 mg/ml solution for ear drops in single-dose container
Form solution, otic in single-dose container
Active substance / Dosage
CIPROFLOXACIN HYDROCHLORIDE · 3,49 mg
FLUOCINOLONE ACETONIDE · 0,25 mg
Prescription type Prescription Only Medicine
ATC code
S02C S02CA S02CA05
Registration number 83244
Manufacturer Laboratorios Salvat S.A.
Cetraxal Plus 3 mg/ml + 0.25 mg/ml solution for ear drops in single-dose container solution, otic in single-dose container

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cetraxal plus 3 mg/ml + 0,25 mg/ml ear drops solution in single-dose container

ciprofloxacin / fluocinolone acetonide

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you and you should not give it to other people, 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 effects not listed in this leaflet. See section 4.

Leaflet contents

  1. What Cetraxal plus is and what it is used for
  2. What you need to know before using Cetraxal plus
  3. How to use Cetraxal plus
  4. Possible side effects
  5. How to store 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 a group of antibiotics called fluoroquinolones.

Ciprofloxacin works by killing bacteria that cause infections,

  • and fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic properties used to treat inflammation and pain.

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow the instructions regarding dosage, administration interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of down the drain or in household waste.

You should consult a doctor if your condition worsens or does not improve after completing the treatment.

2. What you need to know before using Cetraxal plus

Do not use Cetraxal plus:

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

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

Warnings and precautions:

  • This medicine is for ear use only. It must not be swallowed, injected, or inhaled. It should not be applied to the eye.

  • If, after starting treatment, you develop symptoms such as hives (itching) or skin rash, or any other allergic symptoms (e.g., sudden swelling of the face, throat, or eyelids, difficulty breathing), stop using the medicine immediately and contact your doctor. Severe hypersensitivity reactions may require immediate emergency treatment.

  • Inform your doctor if your symptoms do not improve before completing the treatment. As with other antibiotics, infections may sometimes be caused by organisms that are not sensitive to ciprofloxacin. In such cases, your doctor must prescribe appropriate treatment.

  • Contact your doctor if you experience blurred vision or other visual disturbances.

Children:

There is insufficient clinical experience regarding the use of Cetraxal plus in children under 6 months of age. Therefore, you should consult your doctor before administering this medicine to a child of this age.

Use of Cetraxal plus with other medicines:

Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or might need to take/use any other medicines.

The use of Cetraxal plus together with other otic (ear) medications is not recommended.

Pregnancy, breast-feeding, and fertility:

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

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Caution should be exercised when administering Cetraxal plus to a nursing woman, as it is unknown whether Cetraxal plus is excreted in human milk.

Driving and using machines:

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

3. How to use Cetraxal plus

Cetraxal plus is for ear use only (otic use). Always follow exactly the instructions given by your doctor for administering this medicine. 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 daily in the affected ear for 7 days.

Administer Cetraxal plus in both ears only if your doctor has specifically instructed you to do so.

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

Instructions for administration:

  1. The person administering Cetraxal Plus should wash their hands thoroughly with soap and water beforehand.

Two hands holding and preparing a tube-shaped medical device with a transparent tip on a light gray background

  1. Gently clean any discharge that can be easily removed from the outer ear. Do not insert any object or cotton swab into the ear canal.

Black and white illustration of a hand holding a small object near the

  1. Separate a single-dose container from the strip.

A hand grasping the cap of a medical vial among three similar vials, with an arrow indicating a downward tilting motion

  1. Warm the ear drops by holding the single-dose container in your hands for 1 or 2 minutes.

A hand holding and manipulating a glass vial with a press cap on a gray background with the number 4 in the

  1. Twist and pull off the cap from the vial.

A hand rotating a white strip around a cylindrical vial with an arrow indicating clockwise rotational movement

  1. Tilt your head or the patient's head to the side so that the affected ear is facing upward.

Medical illustration with a curved arrow indicating the direction of application of a product on the upper forehead of a face

  1. Instill the contents of one vial into the ear.

A hand stretching the skin while a medical device is pressed toward the upper face, indicated by a downward arrow

8a. For patients with external ear infection, gently pull the earlobe backward and forward. This will help the drops enter the ear canal.

A hand lifting and gently pulling the facial skin upward

8b. For patients with middle ear infection, gently press the (tragic) skin fold at the entrance of the ear canal four times using a pumping motion. This will help the drops pass through the eardrum and reach the middle ear.

An index finger firmly pressing on the forehead of a person above the

  1. Keep the patient's head tilted toward the affected ear for approximately 1 minute to allow the medication to enter the ear. After administering the medication, keeping the head upright or moving it too quickly may cause some of the dose to be lost, as the drops may run out of the ear and fail to enter the ear canal.

Dispose of the vial after use.

Analog clock with hand pointing at minute 1 and the label '1 min' above the face of a person looking toward the

  1. Repeat all steps, if necessary, for the other ear.

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

If you use more Cetraxal plus than you should

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 facility.

If you forget to use Cetraxal plus

Do not use a double dose to make up for missed 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 length of time prescribed by your doctor, even if symptoms improve. If you stop using this medicine too early, the infection may not clear up and symptoms may return or even worsen. Antibiotic resistance may also occur.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you experience any of the following symptoms, stop treatment with this medicine and consult your doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty swallowing or breathing, rashes or hives, sores, ulcers.

Common: may affect up to 1 in 10 people

Ear-related effects: Discomfort, pain, itching.

General adverse effects: Taste disturbance.

Uncommon: may affect up to 1 in 100 people

Ear-related effects: Tinnitus (ringing in the ears), medication residue, blockage of the ear drainage tube, tingling, congestion, reduced hearing, 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.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetraxal plus

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

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

Store below 30°C. Keep the aluminium pouch in the original outer packaging to protect it from light. Discard the aluminium 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 medicines and their containers to your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 millilitre 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 components are polysorbate 80, glycerine, povidone and purified water.

Nature of the product and pack size

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

Marketing Authorisation Holder and Manufacturer

Laboratorios Salvat, S.A.

C/ Gall 30-36

08950 - Esplugues de Llobregat

Barcelona (Spain)

This patient information leaflet was approved in: August 2022

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany InfectoCiproCort 3 mg/ml + 0.25 mg/ml ear drops, solution in single-dose container

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 ear drops solution in single-dose container

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

France CETRAXAL 3 mg + 0.25 mg per ml, solution for auricular instillation in single-dose container

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 ear drops, solution in single-dose container

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 up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):

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