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 otitis externa (outer ear infection) and otitis media (middle ear infection) with ventilation tube drainage, of bacterial origin.

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 contacted 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 contact 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.

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.

Since it has not been confirmed that Cetraxal Plus penetrates 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, 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 ear symptoms have 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.

which can occur when administering a cold solution into the ear canal.

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

• 3. Insert the drops into the ear using the dropper. Do not touch the dropper to the ear or fingers to avoid contamination.

• 4. After inserting the drops into the ear, follow the instructions below for the specific ear infection: For patients with middle ear infection with ventilation tube drainage: 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 tube in the eardrum into the middle ear. For patients with outer ear infection: The patient lies on their side, and the person administering Cetraxal Plus should gently pull the outer ear up and back (figure 4b). This will allow the drops to flow into the ear canal.

• 5. Keep your head 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, follow the administration instructions.

During administration, it is not recommended to keep your head in a vertical position or move it too vigorously, as this may cause the loss of some 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

The symptoms of overdose are not known. In case of overdose or accidental ingestion of the medicine, a doctor or pharmacist should be contacted immediately or the poison control center should be called, 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 have improved earlier. If the treatment 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 drainage tube, tingling, redness, hearing impairment, rash, inflammation, fungal infection of the outer 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 the leaflet, you should tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products

Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cetraxal Plus

The medicine should be stored out of sight and reach of 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 month stated.

After the first opening of the bottle, the medicine should not be used for more than 1 month.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. 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 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 (E 507) and/or sodium hydroxide (E 524) and purified water.

What Cetraxal Plus looks like and contents of the packaging

Cetraxal Plus is a clear, colorless or yellowish solution for ear drops. The packaging of the medicine consists of a white polyethylene bottle with a polyethylene dropper and 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, return all unused medicines to the pharmacy for proper disposal.

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

Marketing authorization holder in Spain, the country of export:

Laboratorios SALVAT, S.A.

• C/ Gall 30-36, 08950 – Esplugues de Llobregat, Barcelona, Spain

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 Alcala de Henares, Madrid, 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

Pharma Innovations Sp. z o.o.

ul. Jagiellońska 76, 03-301 Warsaw

Authorization number in Spain, the country of export:866103.9

Parallel import authorization number:280/19

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, ear drop solution

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: 09.07.2024

[Information about the trademark]