Cetraxal plus

Package leaflet: Information for the patient

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
Ciprofloxacin + Fluocinolone acetonide
Please read the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• 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 another person 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

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 the group known as 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 used in adults and children from 6 months of age for the treatment of acute otitis externa (acute external ear infection) and for the treatment of otitis media (middle ear infection) with a ventilation drain (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 administer 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 sometimes 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 insufficient 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 and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 plans to become pregnant, 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 machinery.
Cetraxal Plus contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use Cetraxal Plus

Cetraxal Plus is intended for ear use only (aural administration).
Always use Cetraxal Plus exactly as directed by your doctor or pharmacist. If in doubt, 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 a doctor.
Your doctor will determine how long you should continue treatment with 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 sideways so that the affected ear faces upward.

3. Instill the drops into the ear using the dropper. Do not touch the dropper to the ear or fingers to avoid contamination.

4. After instilling the drops, follow the instructions below depending on the type of ear infection:
   For patients with otitis media 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.
   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 in an upright position or to move the head vigorously, as this may result in loss of part of the medication, causing the drops to run down the face instead of entering the ear canal.

Keep the bottle until the end of treatment. Do not keep the medication for future use.

Use of more than the recommended dose of Cetraxal Plus
Symptoms of overdose are unknown. In case of overdose or accidental ingestion, contact a doctor or pharmacist immediately, or call the poison control center by telephone, 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. Apply the next dose as scheduled.

Stopping treatment with Cetraxal Plus
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, worsening of symptoms, or development of antibiotic resistance.

If you have any further questions about the use of this medicine, 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 adverse reactions listed below occur, discontinue use of the medicine immediately and contact a doctor without delay:
swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty swallowing or breathing, rash or hives, lesions, 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 medication sensation, drainage obstruction, tingling, hyperemia, hearing impairment, rash, redness, fungal infection of the external ear, ear discharge, swelling, tympanic membrane disorders, granulation tissue, contralateral otitis media.
General adverse reactions: Candida fungal infection, 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 your doctor, pharmacist or nurse.
Adverse reactions can 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 181C, 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 to provide more information on the safety of the medicine.

5. How to store Cetraxal Plus

Keep the medicine out of the sight and reach of children.
Store below 30°C.
After opening, store below 25°C.
Do not use Cetraxal Plus after the expiry date stated on the packaging. 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.
Medicines must 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 ml of Cetraxal Plus contains 3 mg of ciprofloxacin (as ciprofloxacin hydrochloride) and 0.25 mg of fluocinolone acetonide.
• The other ingredients 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 (E 507) and/or sodium hydroxide (E 524), and 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 packaging consists of a white polyethylene bottle with a polyethylene dropper and a polyethylene cap, contained 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 they are necessary for treating a specific illness currently affecting the patient.
Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is known as resistance: certain antibiotic therapies become ineffective.
Overuse of antibiotics increases resistance. Patients may even contribute to the development of bacterial resistance, potentially delaying recovery or reducing the effectiveness of the antibiotic, especially if they do not properly adhere to:

• 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 symptoms resemble 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 the 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 Alcala de Henares, Madrid
Spain

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw

Spanish Marketing Authorisation Number: 866103.9
Parallel Import Authorisation Number: 280/19

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 gotas óticas en solución
France: CETRAXAL 3mg / 0.25mg per ml, solution for auricular 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