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CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS

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About the medicine

How to use CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Contents of the leaflet

  1. Introduction
  2. What Cetraxal otic is and what it is used for
  3. What you need to know before using Cetraxal otic
  4. How to use Cetraxal otic
  5. Possible side effects
  6. Storage of Cetraxal otic
  7. Contents of the pack and further information

Introduction

Package Leaflet: Information for the User

Cetraxal otic 3 mg/ml ear drops in solution in single-dose container

Ciprofloxacin

Read the entire package leaflet carefully before starting to use the medicine, as it contains important information for you

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

Contents of the package leaflet:

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

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

Cetraxal otic is a solution for otic use (in the ear) containing ciprofloxacin, which belongs to the group of antibiotics called fluoroquinolones. Ciprofloxacin acts by eliminating bacteria that cause infections.

Cetraxal otic is indicated in adults and children from 2 years of age for the treatment of acute otitis externa (infection of the outer ear) and chronic suppurative otitis media (infection of the middle ear) of bacterial origin.

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

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

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2. What you need to know before using Cetraxal otic

Do not use Cetraxal otic:

If you are allergic to ciprofloxacin or other quinolones or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

  • Consult your doctor or pharmacist before starting to use Cetraxal otic.
  • This medicine should only be applied in the ear. It should not be ingested, injected, or inhaled. It should not be applied in the eye.
  • If, once treatment has started, symptoms of urticaria (itching) or skin rash or any other allergic symptom (e.g., sudden swelling of the face, throat, or eyelids, difficulty breathing) occur, discontinue the medication immediately and consult your doctor. Severe hypersensitivity reactions may require immediate emergency treatment.
  • Although sensitivity reactions to sunlight are not expected, it is recommended to take protective measures and avoid excessive exposure to direct sunlight while using this medicine.
  • Inform your doctor if 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, the appropriate treatment should be prescribed by your doctor.

Children:

There is insufficient clinical experience with the use of Cetraxal otic in children under 2 years of age, so you should consult your doctor before administering this medicine to your child if they are of this age.

Other medicines and Cetraxal otic

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

It is not recommended to use Cetraxal otic with other ear medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is not recommended during pregnancy and breastfeeding, so your doctor should assess the use of this medicine in each case.

Driving and using machines

There are no clinical data available. However, given the route of administration, it is unlikely that this medicine will affect the ability to drive vehicles or operate machinery.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

3. How to use Cetraxal otic

Follow your doctor's or pharmacist's instructions for administering this medicine exactly. If in doubt, consult your doctor or pharmacist again.

Administration is done directly in the ear.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

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

The recommended dose is:

Adults

Acute otitis externa

Administer the contents of a single-dose container (0.4 ml) in the affected ear twice a day for 7 days.

Chronic suppurative otitis media

Administer the contents of a single-dose container (0.4 ml) in the affected ear twice a day for 10 days.

Elderly patients

No dose adjustment is necessary in this patient group.

Adolescents and children over 2 years

No dose adjustment is necessary in this patient group.

Children under 2 years

Its use is not recommended, as there are no data available for this age group.

Patients with kidney or liver disease

No dose adjustment is necessary in this patient group.

Method of administration

  1. The person administering Cetraxal otic should wash their hands previously with water and soap.

Hand holding a syringe with a needle inserted into the skin showing the angle of injection and skin fold

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

Hand holding a nasal applicator with the index finger pressing the dispenser near the right nostril

  1. Separate a single-dose container from the strip of containers in the bag and put the rest back inside the bag and the box. Check that the vial is in good condition (not broken or deformed).

Hand holding three transparent glass vials with a curved arrow indicating their use and opening

  1. Warm the ear drops by holding the single-dose container between your hands for 1 or 2 minutes to reduce the sensation of cold from the solution when entering the ear.

Hand holding a glass ampoule with a breaker applied to open it and extract the medicine

  1. Twist and pull the cap of the single-dose container.

Applicator device with button pressed on the skin showing medication flow and arrow indicating direction

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

Needle inserted into the skin at a 45-degree angle and a black arrow indicating the direction of insertion

  1. Insert the contents of a single-dose container into the ear.

Thumb pressing the applicator on the skin with an arrow indicating the direction of application

  1. Once the otic solution enters the ear, it is advisable to hold the ear by the top and pull it back to help the preparation penetrate. In this position, empty the contents of the single-dose container by pressing it at least three times inside the ear.

Hand applying a medicinal patch to the area of the closed eyelid with an arrow indicating the direction

  1. Keep your head tilted towards the affected ear for about 5 minutes to allow the medicine to enter the interior of the ear. Once the medicine has been administered in the ear, keeping the head in a vertical position or moving the head too quickly may cause part of the administered medication to be lost because the drops may fall down the face and not penetrate the ear canal.

Discard the single-dose container after administration.

  1. Do not plug the ear with cotton after applying the product, as it may prolong the infection.
  2. Repeat all the steps, if necessary, in the other ear.

If you use more Cetraxal otic than you should:

Although it is difficult to overdose with this medicine, it is recommended that, in case of accidental ingestion or overdose, you consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Cetraxal otic

Do not administer a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The adverse reactions described are rare(may affect up to 1 in 100 people)

- Dizziness, headache, vertigo.

-Ear pain, passage of the product from the ear to the mouth.

-Eczema, skin rash, or itching, stinging sensation at the time of application.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetraxal otic

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

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

This medicine does not require special storage conditions. Keep the single-dose containers inside the protective sleeve, preferably inside the box.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cetraxal otic
  • The active substance is ciprofloxacin. Each milliliter of solution contains 3 mg of ciprofloxacin.
  • The other components are: lactic acid 90%, povidone, anhydrous glucose, sodium hydroxide solution, and purified water.

Appearance of the product and contents of the pack

Cetraxal otic is a medicine that comes in the form of ear drops in solution for administration in the ear. Each single-dose container contains 0.4 ml of sterile and transparent solution.

Marketing authorization holder and manufacturer

Laboratorios Salvat, S.A.

C/ Gall 30 – 36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Date of the last revision of this package leaflet: July 2006.

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Tetiana Fursenko

Otolaryngology (ENT) 5 years exp.

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Frequently Asked Questions

Is a prescription required for CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS?
CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS?
The active ingredient in CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS is ciprofloxacin. This information helps identify medicines with the same composition but different brand names.
How much does CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS cost in pharmacies?
The average pharmacy price for CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS is around 6.01 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS?
CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS is manufactured by Laboratorios Salvat S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to CETRAXAL OTIC 3 mg/ml OTIC DROPS IN SOLUTION IN SINGLE-DOSE CONTAINERS?
Other medicines with the same active substance (ciprofloxacin) include ACEOTO 3 mg/ml EYE DROPS SOLUTION, CETRAXAL OTIC 3 mg/ml EAR DROPS SOLUTION, CIPROFLOXACIN QUALIGEN 1mg OPHTHALMIC SOLUTION SINGLE-DOSE CONTAINERS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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