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 (inflammation of the outer ear) and otitis media (inflammation of the middle ear) with ventilation tube insertion, of bacterial origin.
Consult a doctor if there is no improvement or if the patient feels worse after completing 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. Do not swallow, inject, or inhale it. Do not put it in 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), discontinue treatment and contact a doctor immediately. Severe allergic reactions may require immediate emergency treatment.
• Tell the doctor if 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 such cases, the doctor will initiate appropriate treatment.
• If the patient experiences blurred vision or other vision disturbances, 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, consult a doctor.

Cetraxal Plus and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines obtained without a prescription.
It is not recommended to take this medicine in combination with other ear drops.

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 inform their doctor or pharmacist before using this 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 machinery.

3. How to use Cetraxal Plus

Cetraxal Plus is intended for administration into the ear only (otic use).
Cetraxal Plus should always be used according to the doctor's or pharmacist's recommendations. In case of doubts, consult a doctor or pharmacist.
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 use Cetraxal Plus. To avoid recurrence of the infection, do not stop treatment too early, even if the ear symptoms have 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 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 the head / child's head to the side, directing 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
(inflammation of the outer ear)gently pull the earlobe
upwards and outwards. This will allow the drops
to flow down the ear canal.
8b. In the case of patients with otitis media

(inflammation of the middle ear): press the tragus
(a small flap 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. Lifting the head to an upright position or moving too much during administration may cause some of the medicine to leak out of the ear canal. Avoid such actions, as they may prevent the medicine from reaching the deeper parts of the ear canal.

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 more than the recommended dose of Cetraxal Plus

There are no known symptoms of overdose. In case of overdose or accidental ingestion of the medicine, contact a 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 center.

Missing a dose of Cetraxal Plus

Do not take a double dose to make up for a missed dose. Take the next dose according to the schedule.

Stopping the use of Cetraxal Plus

Do not stop using Cetraxal Plus 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 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, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Cetraxal Plus can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop using the medicine and inform your doctor immediately:
swelling of the hands, feet, ankles, face, lips, mouth, or throat, difficulty swallowing or breathing, rash or hives, wounds, 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 ear canal, tingling, redness, hearing impairment, rash, inflammation, fungal infection of the outer ear, ear discharge, swelling, eardrum disturbances, 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 the available data):
Vision disturbances: blurred vision

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can also be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cetraxal Plus

Keep the medicine out of the reach and sight of children.
Do not use Cetraxal Plus after the expiry date stated on the label after "EXP". The expiry date refers to the last day of that month.
Store in 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 immediately after use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cetraxal Plus contains

• The active substances are: ciprofloxacin in the form of ciprofloxacin hydrochloride and fluocinolone acetonide. 1 ml of the medicine contains 3 mg of ciprofloxacin (in the form of ciprofloxacin hydrochloride) 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 K90F, and purified water.

What Cetraxal Plus looks like and contents of the pack

Cetraxal Plus is a clear, colorless or yellowish solution for ear drops, intended for otic use, in a single-dose container. To protect the containers, they are placed in a sachet made of reinforced aluminum foil. Each pack 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.
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,
• 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 condition occurs.

• 4. Never give your antibiotic to another person; it may not be suitable for their illness
• 5. After completing the treatment, return all unused medicines to the pharmacy for proper disposal.

Marketing authorization holder and manufacturer

Marketing authorization holder

TACTICA Pharmaceuticals Sp. z o.o.
ul. Królowej Jadwigi 148a/1a
30-212 Kraków
tel.: +48 889 388 538
{logo of the marketing authorization holder}

Manufacturer

Laboratorios SALVAT, S.A.
C/ Gall, 30-36
Esplugues de Llobregat
08950 Barcelona
Spain

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 gotas óticas en solución en envase unidosis
France
CETRAXAL 3mg / 0,25mg par ml, solution pour instillation auriculaire en récipient unidose
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 ušní kapky, roztok v jednodávkovém obalu
Denmark
Cetraxal Comp 3 mg/ml + 0,25 mg/ml Øredråber, opløsning i endosebeholder
Finland
Cetraxal Comp 3 mg/ml + 0,25 mg/ml Korvatipat, liuos, kerta-annospakkaus
Romania
Cexidal 3 mg/ml + 0,25 mg/ml Picături auriculare, soluţie în recipient unidoză
Slovakia
Infalin duo 3 mg/ml + 0,25 mg/ml Ušná roztoková instilácia v jednodávkovom obale
Sweden
Cetraxal Comp 3 mg/ml + 0,25 mg/ml Örondroppar, lösning i endosbehållare
Norway
Cetraxal Comp 3 mg/ml + 0,25 mg/ml øredråper, oppløsning i endosebeholder
Iceland
Cetraxal Comp 3 mg/ml + 0,25 mg/ml Eyrnadropar, lausn í stakskammtaíláti
Germany
InfectoCiproCort 3 mg/ml + 0,25 mg/ml Ohrentropfen, Lösung im Einzeldosisbehältnis

Date of last revision of the package leaflet