Label: information for the user

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

Ciprofloxacin

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.

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

• Consult your doctor or pharmacist before starting to use Cetraxal otic.
• This medication should only be applied to the ear. Do not ingest, inject, or inhale. Do not apply to the eye.
• If once started treatment symptoms of urticaria (itching) or skin rash or any other allergic symptom (for example, 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.
• Although no sun sensitivity reactions are expected, it is recommended to take protective measures and avoid excessive exposure to direct sunlight while using this medication.
• 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.

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.

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

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.

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.

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.

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.