Cetraxal plus

Package leaflet: Information for the patient

Warning! Keep this 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 single-dose container
Ciprofloxacin + Fluocinolone acetonide
Cetraxal Plus and Infalin Duo are different trade names for 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.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• 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, please consult your doctor, pharmacist, or nurse. See section 4.

Leaflet 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 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.

The medicine 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 drainage tube (tympanostomy tube), of bacterial origin.
Please 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 apply it to 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 a child in this age group.
Cetraxal Plus and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines obtained without a prescription.
The concomitant use of Cetraxal Plus 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 it has not been confirmed whether Cetraxal Plus passes into human breast milk, particular 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 (otologic use).
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 the contents of a single-dose container applied to 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 symptoms improve.

Instructions for use

1. The person administering Cetraxal Plus should wash their hands thoroughly 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 package.
4. Warm the drops by holding the package in your hands for 1–2 minutes.

5. Unscrew the cap of the package.
6. Tilt the 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 with external ear infection: Gently pull the earlobe upward and outward to allow the drops to flow down the ear canal.
8b. For patients with middle ear infection: Press four times on the tragus (the small cartilage flap located in front of the ear canal) toward the inner ear. This helps the medication penetrate into the middle ear, allowing the drops to pass through the ear canal to the eardrum and middle ear.

9. The patient should remain with the head tilted for about one minute to allow the drops to penetrate the ear. Raising the head to an upright position or moving too quickly during administration may cause some of the medication to leak out of the ear canal. Avoid this, as it may prevent the medication from reaching deeper parts of 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 your doctor or pharmacist immediately, call a poison control center, stating 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 resolve 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 any of the reactions listed below 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 hives, sores, ulcers.

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

Uncommon: may occur in up to 1 in 100 patients
Local adverse reactions in the ear: tinnitus, residual medicine sensation, blocked drainage, tingling, hyperaemia, hearing impairment, rash, redness, fungal infection of the external ear, ear discharge, swelling, tympanic membrane disorders, granulation tissue, otitis media in the contralateral ear.
General adverse reactions: Candida fungal infection, irritability, excessive tearing, 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 also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +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 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 specified 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 should 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 pack and other information

• The active substances in the medicine are: ciprofloxacin in the form of ciprofloxacin hydrochloride monohydrate and fluocinolone acetonide. 1 ml of the medicine 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 components are: 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 yellowish solution for ear drops intended for
aural 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, 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 treatments become ineffective.
Overuse of antibiotics increases resistance. The patient 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 adhere to:

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

Therefore, to ensure effective treatment:

1. Use antibiotics only when prescribed by a doctor.
2. Strictly follow the 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 responsible party or parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
Laboratorios Salvat, S.A.
Gall 30-36, 08950 Esplugues de Llobregat
Barcelona, Spain
Manufacturer:
Laboratorios Salvat, S.A.
Gall 30-36, 08950 Esplugues de Llobregat
Barcelona, Spain
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in the Czech Republic, country of export: 69/035/17-C
Parallel Import Authorisation Number: 233/22
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Spain Cetraxal Plus 3 mg/ml + 0.25 mg/ml gotas óticas en solución en envase unidosis
France CETRAXAL 3 mg / 0.25 mg 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