Cetraxal plus

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

• Keep this leaflet, as you may need to read it again.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else even if their symptoms are the same.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Cetraxal Plus is and what it is 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 Cetraxal Plus is and what it is 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 causing 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 indicated for use 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 tubes (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 or 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 apply it into 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 the 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 infants in this age group.

Cetraxal Plus with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or might take. 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.
Due to the fact that penetration of Cetraxal Plus into human breast milk has 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 influence on the ability to drive or operate dangerous machinery.

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

3. How to use Cetraxal Plus

Cetraxal Plus is intended for ear use only (aural administration).
Cetraxal Plus should always be used as directed by a doctor or pharmacist. If in doubt, consult a 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 a 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.

Administration instructions
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 cold solution into the ear canal.
2. Tilt the head to the side so that the affected ear is facing upward.

3. Administer the drops into the ear using the dropper. Do not let the dropper touch the ear or fingers to avoid contamination.
4. After instilling the drops, follow the instructions below depending on the patient's specific ear condition:
   In patients with middle ear infection with a ventilation 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) four times with a pumping motion. This helps the drops pass through the ventilation tube into the middle ear.

In patients with external ear infection: 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 in an upright position or to move the head too quickly, as this may cause loss of some of the medication, with drops running down the face instead of entering the ear canal.

Keep the bottle until the end of treatment. Do not store the medication for future 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 a doctor or pharmacist immediately, or call a poison control center, providing the name of the medication and the amount taken, or go to the nearest medical facility.

Missed dose of Cetraxal Plus
Do not use a double dose to make up for a missed dose. Use the next dose according to the prescribed schedule.

Stopping treatment with Cetraxal Plus
Do not stop using Cetraxal Plus without consulting a doctor or pharmacist. It is very important to use these ear drops for the full duration prescribed by the doctor, even if symptoms improve earlier. Stopping treatment early may lead to recurrence of infection, with symptoms returning or worsening. It may also lead to development of antibiotic resistance.

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

4. Possible adverse reactions

Like all medicines, Cetraxal Plus can cause adverse reactions, although not everyone experiences them.
If serious allergic reactions or any of the following adverse reactions occur, discontinue use of the medicine immediately and contact your doctor without delay:
swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty swallowing or breathing, rash or urticaria, lesions, ulcers.

Frequent: 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 medication sensation, drainage obstruction, tingling, hyperaemia, hearing impairment, rash, erythema, fungal infection of the external ear, ear discharge, oedema, tympanic membrane disorders, granulation tissue, contralateral middle ear infection.
General adverse reactions: Candida fungal infection, irritability, excessive lacrimation, dizziness, skin redness, headache, vomiting, fatigue.

Unknown frequency (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 your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C; 02-222 Warsaw, tel: (+48) 22 49 21 301, fax: (+48) 22 49 21 309, Website: http://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Cetraxal Plus

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

6. Contents of the pack 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.
• The other components are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), povidone, diethylene glycol monoethyl ether, glycereth-26 (a glycerin and ethylene oxide compound), hydrochloric acid and/or sodium hydroxide (pH adjuster), and purified water.

What Cetraxal Plus looks like and contents of the pack
Cetraxal Plus is a clear, colourless or slightly yellowish solution for ear drops.

White polyethylene bottles with a polyethylene dropper, closed with a polyethylene cap, packed in a cardboard box.
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 resistance. Patients may even contribute to the development of bacterial resistance and thus delay recovery or reduce the effectiveness of the antibiotic if they do not properly follow:

• dosage instructions,
• the prescribed 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 you have a similar illness.
4. Never give your antibiotics to someone else; they may not be appropriate for treating that person's 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 the parallel importer.

Marketing Authorisation Holder in Spain, country of export:
Laboratorios Salvat, S.A.
C/Gall 30-36
08950 - Esplugues de Llobregat, Barcelona
Spain

Manufacturers:
Pharmaloop S.L.
C/Bolivia, 15 - Polig. Industrial Azque
28806 Alcala de Henares, Madrid
Spain
Laboratorios Salvat, S.A.
C/Gall 30-36, 08950 - Esplugues de Llobregat, Barcelona
Spain
InfectoPharm GmbH
Von-Humboldt-Strabe 1
64646 Heppenheim
Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Spanish Marketing Authorisation Number (country of export): 866103.9
Parallel Import Authorisation Number: 259/22

This medicinal product is authorised for sale in the European Economic Area (EEA) under the following names:
Spain: Cetraxal Plus 3 mg/ml + 0.25 mg/ml gotas óticas en solución
France: CETRAXAL 3 mg / 0.25 mg 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