Cetraxal plus

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Cetraxal Plus, 3 mg/ml + 0,25 mg/ml, ear drops, solution
Ciprofloxacin + Fluocinolone acetonide
Please read the entire leaflet before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What is Cetraxal Plus and what is it used for
2. Important information 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 is Cetraxal Plus and what is it used for

Cetraxal Plus is a solution for administration into the ear. It contains:

• ciprofloxacin, an antibiotic belonging to a group called fluoroquinolones. Ciprofloxacin kills bacteria that cause infections,
• fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic properties used to treat swelling and pain.

Cetraxal Plus is an ear drop solution. It is used in adults and children from 6 months of age for the treatment of acute otitis externa and for the treatment of otitis media with ventilation drainage (tympanostomy tubes) of bacterial origin.
Consult your doctor if there is no improvement or if the patient feels worse after completing treatment.

2. Important information before using Cetraxal Plus

When not to use Cetraxal Plus

• if the patient is allergic (hypersensitive) to ciprofloxacin, other quinolones, fluocinolone acetonide, or any of the other ingredients of Cetraxal Plus (see section 6).
• if the patient has a viral or fungal ear infection.

Warnings and precautions

• This medicine is for ear use only. Do not swallow, inject, or inhale it. Do not use in the eye.
• If, after starting treatment, the patient develops hives, skin rash, or any other allergic symptoms (e.g. sudden swelling of the face, throat, or eyelids, difficulty breathing), treatment must be stopped immediately and the patient should contact a doctor without delay. Severe allergic reactions may require immediate emergency treatment.
• Inform your doctor if symptoms do not improve before treatment is completed. As with other antibiotics, additional infections caused by organisms resistant to ciprofloxacin may occasionally occur. If such an infection develops, the doctor will initiate appropriate treatment.
• If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Use in children
Due to lack of sufficient clinical data on the use of Cetraxal Plus in children under 6 months of age, consult a doctor before administering this medicine to a child in this age group.

Cetraxal Plus and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use. This includes medicines obtained without a prescription.
Concomitant use with other ear medications is not recommended.

Pregnancy and breastfeeding
Adequate and well-controlled studies with Cetraxal Plus in pregnant women have not been conducted.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should inform her doctor or pharmacist before using this medicine.
Since systemic absorption of Cetraxal Plus and its passage into human breast milk have not been confirmed, caution should be exercised when using Cetraxal Plus during breastfeeding.

Driving and operating machinery
Due to the formulation and route of administration, Cetraxal Plus has no effect on the ability to drive or operate heavy machinery.

Cetraxal Plus contains methyl parahydroxybenzoate and propyl parahydroxybenzoate,
which may cause allergic reactions (delayed-type reactions are possible).

3. How to use Cetraxal Plus

Cetraxal Plus is intended for ear use only (otologic use).
Cetraxal Plus should always be used as directed by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
The recommended dose for adults and children is 6 to 8 drops into the affected ear twice daily for
7 days.
Cetraxal Plus may be used in both ears only if specifically instructed by your doctor.
Your doctor will determine how long you should use Cetraxal Plus. To prevent recurrence of
infection, do not stop treatment too early, even if the condition of the ear(s) has improved.
Instructions for use
The person administering Cetraxal Plus should wash their hands.
1.

Warm the drops by holding the bottle in your hands for several minutes to avoid
dizziness that may occur when instilling a cold solution into the ear canal.

2. Tilt the head sideways so that the affected ear is facing upward.

3. Instill the drops into the ear using the dropper. Do not touch the ear or fingers with the

dropper to avoid contamination.

4. After instilling the drops, follow the instructions below depending on the patient's specific ear infection:
   For patients with otitis media with ventilation drainage tube: The patient should lie on their side, and the person administering Cetraxal Plus should gently press the skin at the entrance of the ear canal (Figure 4a) 4 times with a pumping motion. This helps the drops pass through the drainage tube in the eardrum into the middle ear.

For patients with otitis externa: The patient should lie on their side, and the person administering Cetraxal Plus should gently pull the earlobe upward and backward (Figure 4b). This allows the drops to flow into the ear canal.

5. Keep the head tilted for about 1 minute to allow the medication to penetrate the ear.
6. If necessary, repeat the procedure for the other ear.

To ensure effective action of the medication in the ear, follow the administration instructions carefully.
During instillation, it is not advisable to keep the head upright or to move the head too quickly, as this may cause loss of part of the medication, since the drops may run down the face instead of entering the ear canal.
Keep the bottle for the duration of treatment. Do not save the medication for later use.
Use of more than the recommended dose of Cetraxal Plus
Symptoms of overdose are not known. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Poison Information Center by telephone, providing the name of the medicine and the amount taken, or go to the nearest medical care facility.
Missed dose of Cetraxal Plus
Do not use a double dose to make up for a missed dose. Use the next dose as scheduled.
Stopping Cetraxal Plus treatment
Do not stop using Cetraxal Plus without consulting your doctor or pharmacist.
It is very important to use these ear drops for the full duration prescribed by your doctor, even if symptoms improve earlier. Stopping treatment prematurely may result in recurrence of infection, with symptoms returning or even worsening. Antibiotic resistance may also develop.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Cetraxal Plus can cause adverse reactions, although not everyone experiences them.
If serious allergic reactions or any of the adverse reactions listed below occur, stop using the medicine immediately and contact a doctor without delay:
swelling of hands, feet, ankles, face, lips, mouth or throat, difficulty swallowing or breathing, rash or hives, sores, ulcers.

Common: may affect up to 1 in 10 patients
Local adverse reactions in the ear: discomfort, pain, itching.
General adverse reactions: taste disturbances.

Uncommon: may affect up to 1 in 100 patients
Local adverse reactions in the ear: tinnitus, residual medicine sensation, drainage tube blockage, tingling, hyperaemia, hearing impairment, rash, redness, fungal infection of the external ear, ear discharge, swelling, tympanic membrane disorders, granulation tissue, otitis media of the second ear.
General adverse reactions: fungal infection caused by Candida species, irritability, excessive tear production, dizziness, skin redness, headache, vomiting, fatigue.

Unknown (frequency cannot be estimated from available data)
Visual disturbances: blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C; 02-222 Warsaw, phone: (+48 22) 49 21 301, fax: (+48 22) 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Cetraxal Plus

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
After first opening the bottle, do not use the medicine for longer than 1 month. After opening, store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the Package and Other Information

What Cetraxal Plus Contains

• The active substances are: ciprofloxacin in the form of ciprofloxacin hydrochloride and fluocinolone acetonide. 1 millilitre of Cetraxal Plus contains 3 mg of ciprofloxacin (as ciprofloxacin hydrochloride) and 0.25 mg of fluocinolone acetonide.
• Other components are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), povidone, ethylene glycol monoethyl ether, glycereth-26 (a compound of glycerine and ethylene oxide), hydrochloric acid and/or sodium hydroxide, purified water.

What Cetraxal Plus Looks Like and Contents of the Pack
Cetraxal Plus is a clear, colourless or slightly yellow solution for ear drops.
The medicine is supplied in white polyethylene bottles with a polyethylene dropper and a polyethylene cap.
Each bottle contains 10 ml of solution.

Advice and Medical Education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics, it is because you have a specific bacterial condition that requires treatment.
However, even when antibiotics are used, some bacteria may survive or multiply. This phenomenon is known as resistance: certain antibiotic treatments become ineffective.
Overuse of antibiotics increases the development of resistance. Patients may contribute to the development of bacterial resistance and thus delay recovery or reduce the effectiveness of antibiotics if they do not follow:

• the prescribed dosage,
• the recommended dosing schedule,
• the duration of treatment.

Therefore, to ensure effective treatment, you should:

1. Use antibiotics only when prescribed by a doctor.
2. Strictly follow your doctor's instructions.
3. Do not reuse antibiotics without a doctor's prescription, even if symptoms seem similar to a previous illness.
4. Never give your antibiotics to another person; they may not be appropriate for treating their condition.
5. After completing treatment, return any unused medicines to a pharmacy for proper disposal.

For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Spain, the country of export:
Laboratorios SALVAT, S.A., C/ Gall 30-36, 08950 - Esplugues de Llobregat, Barcelona, Spain
Manufacturer:
Laboratorios SALVAT, S.A.
C/ Gall 30-36
08950 - Esplugues de Llobregat
Barcelona, Spain
Pharmaloop, S.L.
C/Bolivia, 15 - Polig. Industrial Azque
28806 Alcalá de Henares
Madrid, Spain
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish Marketing Authorisation Number (country of export): 866103.9
Parallel Import Licence Number: 226/19
This medicinal product is authorised for sale in the European Economic Area under the following names:
Spain Cetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops solution
France CETRAXAL 3mg / 0.25mg per ml, solution for ear instillation
Poland Cetraxal Plus
Czech Republic Infalin duo 3 mg/ml + 0.25 mg/ml ušní kapky, roztok
Denmark Cetraxal Comp 3 mg/ml + 0.25 mg/ml Øredråber, opløsning
Finland Cetraxal Comp 3 mg/ml + 0.25 mg/ml Korvatipat, liuos
Romania Cexidal 3 mg/ml + 0.25 mg/ml Picături auriculare, soluţie
Slovakia Infalin duo 3 mg/ml + 0.25 mg/ml Ušná roztoková instilácia
Sweden Cetraxal Comp 3 mg/ml + 0.25 mg/ml Örondroppar, lösning
Norway Cetraxal Comp
Iceland Cetraxal Comp 3 mg/ml + 0.25 mg/ml Eyrnadropar, lausn
Germany InfectoCiproCort 3 mg/ml + 0.25 mg/ml Ohrentropfen, Lösung