Cetraxal plus

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Cetraxal Plus (Infalin Duo)
3 mg/ml + 0,25 mg/ml, ear drops, solution in a single-dose container
Ciprofloxacin + Fluocinolone acetonide
Cetraxal Plus and Infalin Duo are different brand names of the same medicine.
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 give it to others. This medicine may harm another person 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 of the leaflet

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 the group called fluoroquinolones. Ciprofloxacin kills bacteria causing infections,
• fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic properties used to treat swelling and pain.

The medicine is used in adults and children from 6 months of age for the treatment of acute external otitis (acute otitis externa) and for the treatment of bacterial middle ear infection (otitis media) with a ventilation drainage tube (tympanostomy tube).
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 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 discontinued 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 during treatment. 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
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription.
Concomitant use with other ear medications is not recommended.

Pregnancy and breastfeeding
Adequate and 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 passage 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.

3. How to use Cetraxal Plus

Cetraxal Plus is intended for ear use only (otic administration).
Cetraxal Plus must always be used as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
The recommended dose for adults and children is the contents of a single-dose container administered into the affected ear twice daily for 7 days.
Cetraxal Plus may be used in both ears only if specifically instructed by a physician.
Your doctor will determine how long you should use Cetraxal Plus. To avoid recurrence of infection, do not discontinue treatment too early, even if the condition of the ear(s) has improved.

Instructions for use

1. The person administering Cetraxal Plus should wash their hands with soap and water.

2. Gently remove any easily accessible discharge from the outer ear area. Do not insert any objects or cotton swabs into the ear canal.

3. Tear off one single-dose container.

4. Warm the drops by holding the container in your hands for 1–2 minutes.

5. Unscrew the cap of the container.

6. Tilt the head (or child's head) sideways so that the affected ear faces upward.

7. Instill the entire contents of the single-dose container into the ear.

8a. For patients suffering from otitis externa: gently pull the earlobe upward and outward. This will help the drops flow down the ear canal.

8b. For patients suffering from otitis media: press four times on the tragus (the small cartilaginous protrusion in front of the ear canal) toward the inside of the ear, which will assist the medication in penetrating into the middle ear. This maneuver allows the drops to pass through the ear canal to the eardrum and into the middle ear.

9. The patient should remain with head tilted for approximately one minute to allow the drops to penetrate the ear. Raising the head to an upright position or moving too quickly during instillation may cause some of the medication to leak out of the ear canal. Avoid such actions, as they may prevent the medication from reaching deeper into the ear canal. After administration, discard the single-dose container.

10. If necessary, repeat all steps for the other ear.

It is extremely important to follow the instructions provided in this leaflet to ensure optimal effectiveness of the medication.

Use of more than the recommended dose of Cetraxal Plus
Symptoms of overdose are unknown. In case of overdose or accidental ingestion, contact a physician or pharmacist immediately, or call the local 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. Administer the next dose according to the prescribed schedule.

Stopping treatment with Cetraxal Plus
Do not discontinue use of Cetraxal Plus without consulting your physician 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 medication, consult your physician or pharmacist.

4. Possible adverse reactions

Like any medicine, Cetraxal Plus can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur, stop using the medicine immediately and inform your doctor without delay:
swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty swallowing or breathing, rash or urticaria, 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, drainage obstruction, tingling, hyperaemia, hearing impairment, rash, redness, fungal infection of the external ear, ear discharge, swelling, tympanic membrane disorders, granulation tissue, middle ear infection in the contralateral ear.
General adverse reactions: fungal infection with 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 your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: 22 49-21-301, Fax: 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.
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.
Store below 30°C. Keep the single-dose container in the sachet to protect it from light.
Discard 7 days after first opening the sachet.
After first opening the single-dose container: use immediately and discard the single-dose container immediately after use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 monohydrate and fluocinolone acetonide. 1 ml of the medicinal product contains 3 mg ciprofloxacin (as ciprofloxacin hydrochloride monohydrate) and 0.25 mg fluocinolone acetonide. Each single dose (0.25 ml) contains 0.75 mg ciprofloxacin and 0.0625 mg fluocinolone acetonide.
• Other ingredients: polysorbate 80, glycerol, povidone K 90, 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 for otic use, contained in a single-dose container. For protection, the single-dose containers are placed in an aluminium foil sachet. Each pack contains 15 single-dose containers.

Advice and medical education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics, their use is necessary due to a specific illness currently affecting the patient.
Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is known as resistance: certain antibiotic treatments become ineffective.
Overuse of antibiotics leads to increased resistance. The patient may even contribute to the development of bacterial resistance, thereby delaying recovery or reducing the effectiveness of the antibiotic, if the following are not properly observed:

• dosage,
• dosing schedule,
• duration of treatment.

Therefore, to ensure effective treatment:

1. Use antibiotics only when prescribed by a doctor.
2. Follow your doctor's instructions exactly.
3. Do not reuse antibiotics without a doctor's prescription, even if symptoms are 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 the Czech Republic, country of export:
Laboratorios Salvat, S.A.
Gall 30-36, 08950 Barcelona - Esplugues de Llobregat, Spain
Manufacturer:
Laboratorios Salvat, S.A.
Gall 30-36, 08950 Barcelona - Esplugues de Llobregat, 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
Marketing authorisation number in the Czech Republic, country of export: 69/035/17-C
Parallel import authorisation number: 318/22
This medicinal product is authorised for supply in the European Economic Area member states under the following names:
Spain Cetraxal Plus 3 mg/ml + 0.25 mg/ml gotas óticas en solución en envase unidosis
France CETRAXAL 3mg / 0.25mg per ml, solution for auricular instillation in single-dose container
Poland Cetraxal Plus 3 mg/ml + 0.25 mg/ml, ear drops, solution in single-dose container
Czech Republic Infalin duo 3 mg/ml + 0.25 mg/ml ušní kapky, roztok v jednodávkovém obalu
Denmark Cetraxal Comp 3 mg/ml + 0.25 mg/ml Øredråber, opløsning i endosebeholder
Finland Cetraxal Comp 3 mg/ml + 0.25 mg/ml Korvatipat, liuos, kerta-annospakkaus
Romania Cexidal 3 mg/ml + 0.25 mg/ml Picături auriculare, soluţie în recipient unidoză
Slovakia Infalin duo 3 mg/ml + 0.25 mg/ml Ušná roztoková instilácia v jednodávkovom obale
Sweden Cetraxal Comp 3 mg/ml + 0.25 mg/ml Örondroppar, lösning i endosbehållare
Norway Cetraxal Comp 3 mg/ml + 0.25 mg/ml øredråper, oppløsning i endosebeholder
Iceland Cetraxal Comp 3 mg/ml + 0.25 mg/ml Eyrnadropar, lausn í stakskammtaíláti
Germany InfectoCiproCort 3 mg/ml + 0.25 mg/ml Ohrentropfen, Lösung im Einzeldosisbehältnis