Background pattern
Cetraxal otico 3 mg/ml gotas oticas en solucion en envase unidosis

Cetraxal otico 3 mg/ml gotas oticas en solucion en envase unidosis

About the medicine

How to use Cetraxal otico 3 mg/ml gotas oticas en solucion en envase unidosis

Introduction

Label: information for the user

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

Ciprofloxacin

Read the label carefully before starting to use the medication, as 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 only to you and should not be given to others, even if they have the same symptoms as you, 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 otico and what is it used for

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

Cetraxal otico is indicated for adults and children aged 2 years and older 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 do not work for viral infections such as the flu or a cold.

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

Do not store or reuse this medication. If you have any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

2. What you need to know before starting to use Cetraxal otic

Do not use Cetraxal otic:

If you areallergic to ciprofloxacin or other quinolones or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Children:

There is not enough clinical experience on the use of Cetraxal otic in children under 2 years, so you should consult with your doctor before administering this medication to your child if they are this age.

Other medications and Cetraxal otic

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

It is not recommended to use Cetraxal otic with other otic medications.

Pregnancy and breastfeeding

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

This medication is not recommended during pregnancy and breastfeeding, so it is your doctor who should evaluate the use of this medication in each case.

Driving and operating machinery

No clinical data are available. However, given the administration route, it is unlikely that this medication will affect your ability to drive vehicles or operate machinery.

3. How to Use Cetraxal Ear Drops

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The administration is carried out directly in the ear.

If you estimate that the action of this medication is too strong or too weak, inform 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 external otitis

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

Chronic suppurative middle ear infection

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

Older adults

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

Use is not recommended in this age group, as there are no available data.

Patients with kidney or liver disease

No dose adjustment is necessary in this patient group.

Administration form

  1. The person administering Cetraxal otic should wash their hands with water and soap beforehand
  1. Gently clean any discharge that can be easily removed from the outer ear. Do not insert any object orswabinto the auditory canal.
  1. Separate a single-dose vial from the strip of vials contained in the bag and store the rest inside the bag and box. Check that the vial is in good condition (does not have cracks or deformations).
  1. Warm the otic drops by holding the single-dose vial between the hands for 1 or 2 minutes, to reduce the sensation of cold from the solution entering the ear.
  1. Turn and pull the dropper of the single-dose vial.
  1. Incline your head or the patient's head to one side so that the affected ear is facing upwards.
  1. Introduce the contents of a single-dose vial into the ear.

8.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, the contents of the single-dose vial will be emptied by pressing at least three times inside the ear.

  1. Keep the head inclined towards the side of the affected ear for approximately 5 minutes to allow the medication to enter the inner ear. Once the medication has been administered in the ear, keep the head in a vertical position or move the head too quickly, it may cause some of the medication to be lost because the drops may fall on the face and not penetrate the inner auditory canal.

Discard the single-dose vial after administration.

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

If you use more Cetraxal otic than you should:

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

If you forgot to use Cetraxal otic

Do not administer a double dose to compensate for the missed doses.

4. Possible Adverse Effects

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

The described adverse reactions areinfrequent (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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this leaflet. You can also report them directly through 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 about the safety of this medication.

5. Cetraxal Otic Storage

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 EXP. The expiration date is the last day of the month indicated.

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

This medication does not require special storage conditions. Store single-use containers within the protective pouch, preferably within the box.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Salvat, S.A.

C/ Gall 30 – 36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Last review date of this leaflet: July 2006.

About the medicine

How much does Cetraxal otico 3 mg/ml gotas oticas en solucion en envase unidosis cost in Spain ( 2025)?

The average price of Cetraxal otico 3 mg/ml gotas oticas en solucion en envase unidosis in August, 2025 is around 6.01 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.

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