Cetraxal Plus

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 that cause infections,
• fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic effects for the treatment of 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 external otitis (acute otitis externa) and for the treatment of middle ear infection (otitis media) with ventilation tube drainage of the ear (tympanostomy tubes), of bacterial origin.
Consult a doctor if there is no improvement or if the patient feels worse after completing the 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 an ear infection caused by viruses or fungi.

Warnings and precautions

• This medicine should only be used in the ear. Do not swallow, inject, or inhale it. Do not put it in the eye.
• If, after starting treatment, the patient experiences hives, skin rash, or any other allergic symptoms (e.g., sudden swelling of the face, throat, or eyelids, difficulty breathing), treatment should be discontinued and a doctor should be consulted immediately. Severe allergic reactions may require immediate emergency treatment.
• The doctor should be informed if the symptoms do not improve before the end of treatment. As with other antibiotics, additional infections caused by organisms resistant to ciprofloxacin may sometimes occur. In the event of such an infection, the doctor will initiate appropriate treatment.
• If the patient experiences blurred vision or other vision disturbances, they should consult a doctor.

Use in children

Due to the lack of sufficient clinical data on the use of Cetraxal Plus in children under 6 months, before administering this medicine to a child of this age, consult a doctor.

Cetraxal Plus and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. This includes medicines obtained without a prescription.
It is not recommended to take this medicine in combination with other ear drops.

Pregnancy and breastfeeding

There have been no adequate and well-controlled studies with Cetraxal Plus in pregnant women.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Given that it has not been confirmed whether Cetraxal Plus passes into breast milk, caution should be exercised when using Cetraxal Plus during breastfeeding.

Driving and using machines

Due to its form and route of administration, Cetraxal Plus does not affect the ability to drive or operate hazardous machinery.
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 administration into the ear only (otic use).
Cetraxal Plus should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults and children is from 6 to 8 drops into the affected ear, twice a day, for 7 days.
Cetraxal Plus can be used in both ears only if advised by a doctor.
Your doctor will decide how long you should use Cetraxal Plus. To avoid the recurrence of infection, do not stop using the drops too early, even if the ear symptoms improve.

Method of administration

The person administering Cetraxal Plus should wash their hands.

• 1. Warm the drops by holding the bottle in your hands for a few minutes to avoid dizziness that may occur when administering a cold solution into the ear canal.

• 2. Tilt your head to the side so that the affected ear is facing upwards.

• 3. Administer the drops into the ear using the dropper. Do not touch the dropper to the ear or fingers to avoid contamination.
• 4. After administering the drops into the ear, follow the specific instructions for the patient's ear infection:

instructions for the patient's specific ear infection:
For patients with middle ear infection with ventilation tube drainage of the ear:
The patient lies on their side, and the person administering Cetraxal Plus should gently press the skin at the entrance to the ear canal (figure 4a) 4 times with a pumping motion. This allows the drops to pass through the drainage tube in the eardrum into the middle ear.
For patients with external ear infection: The patient lies on their side, and the person administering Cetraxal Plus should gently pull the outer ear upwards and backwards (figure 4b). This allows the drops to flow into the ear canal.

• 5. Keep your head tilted for about 1 minute to allow the medicine to enter the ear.
• 6. If necessary, repeat the procedure for the other ear.

To ensure the effectiveness of the medicine in the ear, follow the administration instructions.
During administration, it is not recommended to keep the head in an upright position or move it too vigorously, as this may cause the drops to spill out of the ear canal and not penetrate the ear properly.
Store the bottle until the end of treatment. Do not store the medicine for later use.

Using more than the recommended dose of Cetraxal Plus

There are no known symptoms of overdose. In the event of an overdose or accidental ingestion of the medicine, contact a doctor or pharmacist immediately or contact the poison control center, providing the name of the medicine and the amount taken, or go to the nearest medical facility.

Missing a dose of Cetraxal Plus

Do not take a double dose to make up for a missed dose. Take the next dose according to the schedule.

Stopping the use of 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 period prescribed by the doctor, even if the symptoms improve earlier. If the treatment is stopped too early, the infection may recur, and the symptoms may come back or even worsen. Resistance to the antibiotic may also develop.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cetraxal Plus can cause side effects, although not everybody gets them.
If you experience severe allergic reactions or any of the following side effects, stop using the medicine and inform your doctor immediately:
swelling of the hands, feet, ankles, face, lips, mouth, or throat, difficulty swallowing or breathing, rash or hives, wounds, ulcers.
Common: may affect up to 1 in 10 people
local side effects in the ear:discomfort, pain, itching.
general side effects:taste disturbances.
Uncommon: may affect up to 1 in 100 people
local side effects in the ear:ringing, presence of residual medicine, blockage of the drainage tube, tingling, redness, impaired hearing, rash, redness, fungal infection of the external ear, ear discharge, swelling, eardrum disturbances, granuloma, middle ear infection of the other ear.
general side effects:fungal infection with Candida, irritability, excessive tear production, dizziness, skin redness, headache, vomiting, fatigue.

Unknown (frequency cannot be estimated from the available data):

Vision disturbances: blurred vision

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help 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 in a temperature below 30°C.
Do not use Cetraxal Plus after the expiry date stated on the label after "EXP". The expiry date refers to the last day of that month.
After opening the bottle, do not use the medicine for more than 30 days. After opening, store in a temperature below 25°C.
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 monohydrate and fluocinolone acetonide. 1 ml of Cetraxal Plus contains 3 mg of ciprofloxacin (in the form of ciprofloxacin hydrochloride monohydrate) and 0.25 mg of fluocinolone acetonide.
• The other ingredients are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), povidone, diethylene glycol monoethyl ether, glycereth-26 (a compound of glycerin and ethylene oxide), hydrochloric acid (E507) / sodium hydroxide (E524), and purified water.

What Cetraxal Plus looks like and contents of the pack

Cetraxal Plus is a clear, colorless or yellowish solution for ear drops. The packaging of the medicine is a white, opaque plastic bottle with a dropper.
Each bottle contains 10 ml of solution.

Medical advice and 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 for the specific disease you are currently suffering from.
Despite the use of antibiotics, some bacteria may survive or multiply. This phenomenon is called resistance: some antibiotic therapies become ineffective.
Overuse of antibiotics leads to increased resistance. You may even contribute to the development of bacterial resistance and thus delay recovery or reduce the effectiveness of the antibiotic if you do not follow the:

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

Therefore, to make the treatment effective, you should:

• 1. Use antibiotics only when prescribed.
• 2. Follow the doctor's instructions strictly.
• 3. Do not use antibiotics again without a doctor's prescription, even if you have a similar illness.

• 4. Never give your antibiotic to another person; it may not be suitable for their illness
• 5. After completing the treatment, return all unused medicines to the pharmacy for proper disposal.

Marketing authorization holder and manufacturer

TACTICA Pharmaceuticals Sp. z o.o.
ul. Królowej Jadwigi 148a/1a
30-212 Kraków
tel.: +48 889 388 538

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 Alcalá de Henares, Madrid
SPAIN
InfectoPharm Arzneimittel und Consilium GmbH
Von-Humboldt-Str.1
64646 Heppenheim - GERMANY

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

NAMES OF THE MEDICINAL PRODUCT IN OTHER COUNTRIES:

Spain
Cetraxal Plus 3 mg/ml + 0,25 mg/ml gotas óticas en solución
France
CETRAXAL 3mg / 0,25mg par ml, solution pour instillation auriculaire
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

Date of last revision of the package leaflet