Cetraxal Plus

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Cetraxal Plus

3 mg/ml + 0.25 mg/ml, ear drops, solution

Ciprofloxacin + Fluocinolone acetonide

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 you need to.
• You should consult a doctor, pharmacist, or nurse if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any 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 pack 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. Cetraxal Plus is an ear drop solution. It is for use in adults and children from 6 months of age, for the treatment of acute otitis externa and otitis media with ventilation tube insertion, of bacterial origin.

You should consult a doctor if there is no improvement or if, after completing the treatment, the patient feels worse.

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.
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

Given the 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

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 (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 6 to 8 drops 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 relapse of the infection, treatment should not be stopped too early, even if the condition of the ear has improved.

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. Introduce the drops into the ear using the dropper. Do not touch the ear or fingers with the dropper to avoid contamination.

• 4. After introducing the drops into the ear, follow the instructions below for the specific ear infection of the patient: In patients with otitis media with ventilation tube insertion: 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 will allow the drops to pass through the drainage in the eardrum into the middle ear. In patients with otitis externa: The patient lies on their side, and

the person administering Cetraxal Plus should gently pull the auricle upwards and backwards (figure 4b). This will allow the drops to flow into the ear canal.

• 5. The head should be kept tilted for about 1 minute to allow the medicine to penetrate the ear.
• 6. If necessary, the procedure should be repeated for the other ear.

To ensure the effectiveness of the medicine in the ear, the administration instructions should be followed. During administration, it is not recommended to keep the head in a vertical position or move it too violently, as this may lead to loss of part of the medicine, as the drops will flow down the face instead of penetrating the ear canal.
The bottle should be stored until the end of treatment. The medicine should not be stored for later use.

Using a higher dose of Cetraxal Plus than recommended

There are no known symptoms of overdose. In case of 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 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.

Stopping the use of Cetraxal Plus

The use of Cetraxal Plus should not be stopped 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 not everybody gets them.
If serious allergic reactions or any of the following side effects occur, the use of the medicine should be discontinued and a doctor should be informed 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 disturbances.
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 disturbances, granuloma, otitis media 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 any side effects occur, including any not listed in the leaflet, a doctor, pharmacist, or nurse should be informed. Side effects can also be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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: http://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cetraxal Plus

The medicine should be stored in a place inaccessible and invisible to children. Store in a temperature below 30°C. After opening, store in a temperature below 25°C.
Cetraxal Plus should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
After the first opening of the bottle, the medicine should not be used for more than a month.
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 pack and other information

What Cetraxal Plus contains

• The active substances of the medicine are: ciprofloxacin in the form of ciprofloxacin hydrochloride and fluocinolone acetonide. 1 milliliter of Cetraxal Plus contains 3 mg of ciprofloxacin (in the form of ciprofloxacin hydrochloride) and 0.25 mg of fluocinolone acetonide.
• The other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), povidone, diethylene glycol monoethyl ether, glycereth-26 (a compound of glycerin and ethylene oxide), hydrochloric acid and/or sodium hydroxide (pH regulator), and purified water.

What Cetraxal Plus looks like and what the pack contains

Cetraxal Plus is a clear, colorless or yellowish solution for ear drops.
White polyethylene bottles with a polyethylene dropper, closed with a polyethylene cap, in a cardboard box.
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 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.
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:

• 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 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.

For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Spain, the country of export:

Laboratorios Salvat, S.A.
C/Gall 30-36

• 08950 - Esplugues de Llobregat, Barcelona, Spain

Manufacturer:

Pharmaloop S.L.
C/Bolivia, 15 - Polig. Industrial Azque
28806 Alcala de Henares, Madrid
Spain
Laboratorios Salvat, S.A.
C/Gall 30-36, 08950 - Esplugues de Llobregat, Barcelona
Spain
InfectoPharm GmbH
Von-Humboldt-Strabe 1
64646 Heppenheim
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Spain, the country of export: 866103.9

Parallel import authorization number: 259/22

This medicinal product is authorized 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
France
CETRAXAL 3mg / 0.25mg per ml, solution for ear instillation
Poland
Cetraxal Plus
Czech Republic
Infalin duo 3 mg/ml + 0.25 mg/ml ear drops, solution
Denmark
Cetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution
Finland
Cetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution
Romania
Cexidal 3 mg/ml + 0.25 mg/ml ear drops, solution
Slovakia
Infalin duo 3 mg/ml + 0.25 mg/ml ear drops, solution
Sweden
Cetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution
Norway
Cetraxal Comp
Iceland
Cetraxal Comp 3 mg/ml + 0.25 mg/ml ear drops, solution
Germany InfectoCiproCort 3 mg/ml + 0.25 mg/ml ear drops, solution
Date of leaflet approval: 23.06.2022
[Information about the trademark]