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.

The medicine is used in adults and children from 6 months of age to treat acute otitis externa (outer ear infection) and otitis media (middle ear infection) with ventilation tube insertion, of bacterial origin.
You should consult a doctor if there is no improvement or if the patient feels worse after finishing 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. It should not be swallowed, injected, or inhaled. It should not be administered into 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, a doctor should be consulted.

Cetraxal Plus and other medicines

The doctor or pharmacist should be told 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 available without a prescription.
It is not recommended to take this medicine in combination with other ear medicines.

Pregnancy and breastfeeding

There have been no adequate and well-controlled studies with Cetraxal Plus in pregnant women.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should tell their doctor or pharmacist before using the medicine.
Due to the fact that it has not been confirmed whether Cetraxal Plus penetrates into breast milk, caution should be exercised when using Cetraxal Plus during breastfeeding.

Driving and operating machines

Given the form and route of administration, Cetraxal Plus does not affect the ability to drive vehicles and operate hazardous machinery.

3. How to use Cetraxal Plus

Cetraxal Plus is intended for administration into the ear (otic) only.
Cetraxal Plus should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, a doctor or pharmacist should be consulted.
The recommended dose for adults and children is the contents of a single-dose container administered into the affected ear twice a day for 7 days.
Cetraxal Plus can be used in both ears only if recommended by a doctor.
The doctor will determine how long to take Cetraxal Plus. To avoid a recurrence of the infection, treatment should not be discontinued too early, even if the condition of the ear/ears has improved.

Method of administration

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

• 2. Gently remove any discharge from the outer ear area that can be easily removed. Do not insert any objects or cotton swabs into the ear canal.

• 3. Tear off one container containing a single dose of the medicine.
• 4. Warm the drops by holding the container in your hands

for 1-2 minutes.

• 5. Unscrew the cap of the container.

• 6. Tilt your head to the side to direct

the affected ear upwards.

• 7. Place the entire contents of the container containing a single dose of the medicine into the ear.

8a. In the case of patients with otitis externa
(outer ear infection)gently pull the outer ear upwards and outwards. This will allow the drops to flow down the ear canal.
8b. In the case of patients with otitis media

(middle ear infection): press the tragus (small cartilage in front of the ear canal) four times in the direction of the inner ear, allowing the medicine to penetrate the middle ear. This will allow the drops to pass through the ear canal to the eardrum and middle ear.

• 9. The patient should remain with their 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 medicine to leak out of the ear canal. This should be avoided, as it may prevent the medicine from reaching the inner ear.

After administration, discard the container containing a single dose of the medicine.

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

It is extremely important to follow the instructions in this leaflet to ensure the high effectiveness of the medicine.

Using a higher dose of Cetraxal Plus than recommended

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

Missing a dose of Cetraxal Plus

A double dose should not be taken to make up for a missed dose. The next dose should be taken according to the schedule.

Stopping the use of Cetraxal Plus

Cetraxal Plus should not be discontinued without consulting a doctor or pharmacist.
It is very important to use these ear drops for the period indicated by the doctor, even if the symptoms have disappeared earlier. If the use of the medicine is stopped too early, the infection may recur, and the symptoms may reappear or even worsen. Resistance to the antibiotic may also develop.
In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Cetraxal Plus can cause side effects, although not everybody gets them.
If any of the following side effects occur, the medicine should be discontinued and a doctor should be consulted immediately:
swelling of the hands, feet, ankles, face, lips, mouth, or throat, difficulty swallowing or breathing, rash or hives, sores, ulcers.
Common: may occur in up to 1 in 10 patients
local side effects in the ear:discomfort, pain, itching.
general side effects:taste disturbances.
Uncommon: may occur in up to 1 in 100 patients
local side effects in the ear:ringing, presence of residual medicine, blocked drainage, tingling, redness, impaired hearing, rash, inflammation, fungal infection of the outer ear, ear discharge, swelling, eardrum disturbances, granuloma,
middle ear infection in 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 any side effects occur, including any side effects not listed in the leaflet, a doctor, pharmacist, or nurse should be told. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects will help to gather more information on the safety of the medicine.

5. How to store Cetraxal Plus

The medicine should be stored out of sight and reach of children.
Cetraxal Plus should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store at a temperature below 30°C. Store the single-dose container in a sachet to protect it from light. Discard 7 days after opening the sachet.
After opening the single-dose container: use immediately and discard the container after use.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

• The active substances of the medicine are: ciprofloxacin in the form of ciprofloxacin hydrochloride monohydrate and fluocinolone acetonide. 1 ml of the medicine contains 3 mg of ciprofloxacin (in the form of ciprofloxacin hydrochloride monohydrate) 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.
• The other ingredients are: polysorbate 80, glycerol, povidone K 90, and purified water.

What Cetraxal Plus looks like and what the packaging contains

Cetraxal Plus is a clear, colorless or yellowish ear drop solution for otic use, contained in a single-dose container. To protect the containers, they are placed in a sachet made of aluminum foil.
Each packaging 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 the specific disease currently affecting the patient.
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. 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 follow:

• dosing,
• the treatment schedule,
• the 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 a similar condition occurs.
• 4. Never give your antibiotic to another person; it may not be suitable for their illness.
• 5. After completing the treatment, return any unused medicines to the pharmacy for proper disposal.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the 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 authorization number in the Czech Republic, the country of export:69/035/17-C

Parallel import authorization number: 233/22

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

Spain
Cetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops, solution in a single-dose container
France
CETRAXAL 3 mg / 0.25 mg per ml, solution for ear instillation in a single-dose container
Poland
Cetraxal Plus 3 mg/ml + 0.25 mg/ml, ear drops, solution in a single-dose container
Czech Republic
Infalin duo 3 mg/ml + 0.25 mg/ml ear drops, solution in a single-dose container
Denmark
Cetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution in a single-dose container
Finland
Cetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution in a single-dose container
Romania
Cexidal 3 mg/ml + 0.25 mg/ml ear drops, solution in a single-dose container
Slovakia
Infalin duo 3 mg/ml + 0.25 mg/ml ear drops, solution in a single-dose container
Sweden
Cetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution in a single-dose container
Norway
Cetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution in a single-dose container
Iceland
Cetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution in a single-dose container
Germany
InfectoCiproCort 3 mg/ml + 0.25 mg/ml ear drops, solution in a single-dose container
Date of leaflet approval: 26.05.2022
[Information about the trademark]