Cetraxal Plus

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging 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 necessary.
• 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.
• 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 Cetraxal Plus is and what it is 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 Cetraxal Plus is and what it is 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 (inflammation of the outer ear) and otitis media (inflammation of the middle ear) with ventilation tube drainage, of bacterial origin.

2. Important information before using Cetraxal Plus

When not to use Cetraxal Plus

• if you are allergic (hypersensitive) to ciprofloxacin or other quinolones, fluocinolone acetonide, or any of the other ingredients of Cetraxal Plus (see section 6).
• if you have 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, you experience hives, a rash on the skin, or any other allergic symptoms (e.g., sudden swelling of the face, throat, or eyelids, difficulty breathing), you should stop the treatment and contact your doctor immediately. Severe allergic reactions may require immediate emergency treatment.

If your symptoms do not improve before the end of treatment, you should inform your doctor. As with other antibiotics, additional infections caused by organisms resistant to ciprofloxacin may sometimes occur. In the event of such an infection, your doctor will initiate appropriate treatment.

• If you experience blurred vision or other vision disturbances, you should contact your 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, you should consult a doctor.

Cetraxal Plus and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take. This also applies to medicines that are available without a prescription.

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 plan to become pregnant, you should inform your 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 only.

Cetraxal Plus should always be used in accordance with the recommendations of your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.

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 it has been recommended by your doctor.

Your doctor will determine how long you should take Cetraxal Plus. To avoid a recurrence of the infection, do not stop the treatment 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 up.

• 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 you have: 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 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 earlobe 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, repeat the procedure for the other ear.

To ensure the effectiveness of the medicine in the ear, you should 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 part of the medicine, as the drops will flow down your face rather than penetrating the ear canal.

Keep the bottle 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, you should contact your doctor or pharmacist immediately or call the toxicology information center, providing the name of the medicine and the amount taken, or go to the nearest medical care center.

Missing a dose of Cetraxal Plus

You should not take a double dose to make up for a missed dose. You should take the next dose according to the schedule.

Stopping the use of Cetraxal Plus

You should not stop using Cetraxal Plus without consulting your doctor or pharmacist.

It is very important to use these ear drops for the period indicated by your doctor, even if the symptoms disappear earlier. If you stop using the medicine too early, the infection may recur, and the symptoms may reappear or even worsen. Resistance to the antibiotic may also develop.

If you have any further doubts about using this medicine, you should consult 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, you should stop using the medicine immediately and inform your doctor:

swelling of the hands, feet, ankles, face, lips, mouth, or throat, difficulty swallowing or breathing, rash or hives, sores, 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 drain, tingling, redness, hearing impairment, rash, inflammation, fungal infection of the outer ear, discharge from the ear, 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 inform your doctor, pharmacist, or nurse. You can also report side effects 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, 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.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

After opening the bottle, the medicine should not be used for more than 1 month. After opening, store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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, ethylene glycol monoethyl ether, glycereth-26 (a compound of glycerin and ethylene oxide), hydrochloric acid and/or sodium hydroxide, purified water.

What Cetraxal Plus looks like and what the packaging contains

Cetraxal Plus is a clear, colorless or yellowish ear drop solution. The packaging of the medicine consists of white polyethylene bottles with a polyethylene dropper and a polyethylene cap.

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.

The overuse of antibiotics leads to increased resistance. You may even contribute to the development of bacterial resistance and 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 they have been prescribed.
• 2. Follow your doctor's recommendations 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, you should return all unused medicines 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 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 Alcalá de Henares
Madrid, 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
Spanish authorization number: 866103.9

Parallel import authorization number: 226/19

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

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 approval of the leaflet: 14.05.2024

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