Cetraxal Plus

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. 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 trade names for the same drug.

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• You should consult a doctor, pharmacist, or nurse if you have any further doubts.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person even if the symptoms of their illness are the same.
• If any side effects occur, including any side effects not listed in the leaflet, you should consult a 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 packaging 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 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 in the treatment of acute otitis externa (acute otitis externa) and in the treatment of otitis media (otitis media) with ventilation tube drainage of the ear (tympanostomy tubes), of bacterial origin.
You should consult a doctor if there is no improvement or if the patient feels worse after the treatment is finished.

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 otitis 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 disappear 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 that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take. This also applies to medicines that are available without a prescription.
It is not recommended to take this medicine in combination with other ear medicines.

Pregnancy and breastfeeding

No adequate and well-controlled studies have been conducted 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 that Cetraxal Plus penetrates into breast milk, particular caution should be exercised when using Cetraxal Plus during breastfeeding.

Driving and operating machines

Due to 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 (intratympanic) 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 it has been 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 with soap and water.

• 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 package containing a single dose of the medicine.

• 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/child's head to the side so that the affected ear is facing upwards.

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

8a. In the case of patients with otitis externa:gently pull the auricle upwards and outwards. This will allow the drops to flow down the ear canal.

8b. In the case of patients with otitis media:press the tragus (a small piece of cartilage in front of the ear canal) four times towards the inside of the 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 a 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 inside of the ear canal. After administration, discard the package containing the single dose of the medicine.

• 10. If necessary, repeat all the 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

The symptoms of overdose are not known. In the event of an overdose or accidental ingestion of the medicine, a doctor or pharmacist should be consulted immediately or contact the toxicology information center by phone, providing the name of the medicine and the amount taken, or go to the nearest medical care point.

Missing a dose of Cetraxal Plus

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

Discontinuing 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 disappear 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 they may not occur in everyone.
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, wounds, ulcers.
Common: may occur in up to 1 in 10 patients
local side effects in the ear:discomfort, pain, itching.
general side effects:taste disorders.
Uncommon: may occur in up to 1 in 100 patients
local side effects in the ear:ringing, presence of residual medicine, blockage of the drain, tingling, redness, hearing impairment, rash, redness, fungal infection of the outer ear, ear discharge, swelling, eardrum disorders, granuloma, otitis media 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 available data)
vision disorders: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
tel.: 22 49-21-301, fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected 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 specified 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 package containing a single dose: use immediately and discard the package after a single dose.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Cetraxal Plus contains

• 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 solution of ear drops intended for intratympanic use, contained in a single-dose container. For protection, the single-dose containers are placed in a sachet made of aluminum 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 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.
The 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 the instructions for:

• 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 disease occurs.
• 4. Never give your antibiotic to another person; it may not be suitable for treating their disease.

• 5. After completing the treatment, all unused medicines should be returned to the pharmacy for proper disposal.

To obtain more detailed information, you should 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 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in the Czech Republic, the country of export: 69/035/17-C

Parallel import authorization number: 318/22

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 in solution in a single-dose container
France
CETRAXAL 3mg / 0.25mg 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, single-dose packaging
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: 25.08.2022
[Information about the trademark]