Cetraxal plus

Package leaflet: Information for the user

Cetraxal Plus, 3 mg/ml + 0,25 mg/ml, ear drops, solution in single-dose container
ciprofloxacin + fluocinolone acetonide
Please read the entire leaflet carefully 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 only. 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 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 effects used to treat swelling and pain.

This 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 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. It must not be swallowed, injected, or inhaled. It should not be administered 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, medical advice should be sought.

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 with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use, including those 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
Because of the formulation and route of administration, Cetraxal Plus has no influence on the ability to drive or operate machinery.

3. How to use Cetraxal Plus

Cetraxal Plus is intended for ear use only (aural administration).
Cetraxal Plus should always be used exactly as directed by a doctor or pharmacist. If in doubt, consult a doctor 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 doctor.
Your doctor will determine how long you should use Cetraxal Plus. To avoid recurrence of infection, do not stop 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 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 (or child's head) to the side so that the affected ear faces upward.
7. Instill the entire contents of the single-dose package into the ear.

8a. For patients suffering from external ear infection, gently pull the earlobe upward and outward. This will allow the drops to flow down the ear canal.
8b. For patients suffering from middle ear infection, press four times on the tragus (the small cartilage flap located in front of the ear canal) toward the inside of the ear. This will help the medication penetrate into the middle ear. It enables 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 about 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 deep 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 a higher than recommended dose of Cetraxal Plus
Symptoms of overdose are unknown. In case of accidental overdose or unintentional ingestion of the medication, contact a doctor or pharmacist immediately, or call the local poison control center, providing the name of the medication and the amount taken. Alternatively, 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 discontinue use of 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 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 everybody will experience them.
If any of the adverse reactions listed below occur, discontinue use of 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, 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, presence of residual medicine, blocked drainage, 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 or pharmacist. 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
Adverse reactions can also be reported to the Marketing Authorisation Holder.
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 label after "EXP". 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 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 Package and Other Information

What Cetraxal Plus Contains

• The active substances are: ciprofloxacin in the form of ciprofloxacin hydrochloride and fluocinolone acetonide. 1 ml of the medicinal product contains 3 mg of ciprofloxacin (as ciprofloxacin hydrochloride) and 0.25 mg of fluocinolone acetonide. Each single dose (0.25 ml) contains 0.75 mg of ciprofloxacin and 0.0625 mg of fluocinolone acetonide.
• Other ingredients are: polysorbate 80, glycerol, povidone K90F, 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 intended for
otic use, contained in a single-dose container. For protection, the single-dose containers are placed in a pouch made of reinforced aluminium foil. Each package contains 15 single-dose containers.

Medical Advice and Education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If a 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 therapies become ineffective.
Overuse of antibiotics leads to increased resistance. A patient may even contribute to the development of bacterial resistance and thereby delay recovery or reduce the effectiveness of the antibiotic if the following are not properly observed:

• dosage,
• dosing regimen,
• 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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TACTICA Pharmaceuticals Sp. z o.o.
ul. Królowej Jadwigi 148a/1a
30-212 Kraków
tel.: +48 889 388 538
{logo of the marketing authorisation holder}
Manufacturer
Laboratorios SALVAT, S.A.
C/ Gall, 30-36
Esplugues de Llobregat
08950 Barcelona
Spain
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 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