Cetraxal plus

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Cetraxal Plus, 3 mg/ml + 0,25 mg/ml, ear drops, solution
Ciprofloxacin + Fluocinolone acetonide
Please read the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people even if their symptoms are the same.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, consult your 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 pack 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 a group called fluoroquinolones. Ciprofloxacin kills bacteria that cause infections;
• fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic properties used to treat 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 (acute external ear infection) and for the treatment of otitis media (middle ear infection) with a ventilation drainage tube (tympanostomy tube), of bacterial origin.

Consult your doctor if there is no improvement or if the patient feels worse after completing treatment.

2. Important information before using Cetraxal Plus

When not to use Cetraxal Plus

• if the patient is allergic (hypersensitive) to ciprofloxacin, other quinolones, fluocinolone acetonide, or any of the other ingredients of Cetraxal Plus (see section 6).
• if the patient has a viral or fungal ear infection.

Warnings and precautions

• This medicine is for ear use only. Do not swallow, inject, or inhale it. Do not apply it to the eye.
• If, after starting treatment, the patient develops hives, skin rash, or any other allergic symptoms (e.g. sudden swelling of the face, throat, or eyelids, difficulty breathing), treatment must be stopped immediately and the patient should contact a doctor without delay.

Severe allergic reactions may require immediate emergency treatment.

• Inform the doctor if symptoms do not improve before treatment ends. As with other antibiotics, additional infections caused by organisms resistant to ciprofloxacin may occasionally occur. If such an infection develops, the doctor will initiate appropriate treatment.
• If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Use in children
Due to lack of sufficient clinical data on the use of Cetraxal Plus in children under 6 months of age, consult a doctor before administering this medicine to infants in this age group.

Cetraxal Plus and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription.
Concomitant use with other ear medications is not recommended.

Pregnancy and breastfeeding
Adequate and well-controlled studies with Cetraxal Plus in pregnant women have not been conducted.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should inform her doctor or pharmacist before using this medicine.
Due to the fact that penetration of Cetraxal Plus into human breast milk has not been confirmed, particular caution should be exercised when using Cetraxal Plus during breastfeeding.

Driving and operating machinery
Due to the formulation and route of administration, Cetraxal Plus has no effect on the ability to drive or operate dangerous machinery.

Cetraxal Plus contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (delayed reactions are possible).

3. How to use Cetraxal Plus

Cetraxal Plus is intended for ear use only (otic administration).
Always use Cetraxal Plus exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

The recommended dose for adults and children is 6 to 8 drops into the affected ear twice daily for 7 days.
Cetraxal Plus may be used in both ears only if specifically instructed by your doctor.
Your doctor will determine how long you should use Cetraxal Plus. To prevent recurrence of infection, do not stop treatment too early, even if the condition of the ear(s) improves.

Administration instructions

The person administering Cetraxal Plus should wash their hands.

1. Warm the drops by holding the bottle in your hands for several minutes to avoid dizziness that may occur when instilling a cold solution into the ear canal.

2. Tilt the head to the side so that the affected ear faces upward.

3. Instill the drops into the ear using the dropper. Do not let the dropper touch the ear or fingers to avoid contamination.
4. After instilling the drops into the ear, follow the instructions below depending on the type of ear infection:

For patients with otitis media with ventilation drainage:
The patient should lie on their side. The person administering Cetraxal Plus should gently press the skin at the entrance of the ear canal (Figure 4a) four times with a pumping motion. This helps the drops pass through the ventilation drainage in the eardrum into the middle ear.

For patients with otitis externa: The patient should lie on their side. The person administering Cetraxal Plus should gently pull the earlobe upward and backward (Figure 4b). This allows the drops to flow into the ear canal.

5. Keep the head tilted for approximately 1 minute to allow the medication to penetrate the ear.
6. If necessary, repeat the procedure for the other ear.

To ensure effective action of the medication in the ear, follow the administration instructions carefully. During instillation, avoid keeping the head in an upright position or moving the head too quickly, as this may cause some of the medication to be lost, running down the face instead of entering deeply into the ear canal.

Keep the bottle for use throughout the treatment period. Do not save unused medication for future use.

Use of more than the recommended dose of Cetraxal Plus
Symptoms of overdose are unknown. In case of overdose or accidental ingestion of the medication, contact your doctor or pharmacist immediately, call a poison control center, providing the name of the medication and the amount taken, or go to the nearest medical facility.

Missed dose of Cetraxal Plus
Do not use a double dose to make up for a missed dose. Use the next dose according to the prescribed schedule.

Stopping use of Cetraxal Plus
Do not stop using Cetraxal Plus without consulting your doctor or pharmacist. It is very important to use these ear drops for the full duration prescribed by your doctor, even if symptoms improve earlier. Stopping treatment prematurely may lead to recurrence of infection, worsening of symptoms, or development of antibiotic resistance.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cetraxal Plus can cause side effects, although not everybody will experience them.
If serious allergic reactions or any of the side effects listed below occur, stop using the medicine immediately and inform your doctor without delay:
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 patients
Local adverse reactions in the ear: discomfort, pain, itching.
General adverse reactions: taste disturbances.

Uncommon: may affect up to 1 in 100 patients
Local adverse reactions in the ear: tinnitus, residual medicine, blocked drain, tingling, hyperaemia, hearing impairment, rash, redness, fungal infection of the outer ear, ear discharge, swelling, tympanic membrane disorders, granulation tissue, middle ear infection in the contralateral ear.
General adverse reactions: Candida fungal infection, irritability, excessive tear production, dizziness, skin redness, headache, vomiting, fatigue.

Unknown (frequency cannot be estimated from available data):
Vision disorders: blurred vision

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Side effects can also be reported to the responsible entity or parallel importer.

By reporting side effects, additional information on the safety of this medicine can be collected.

5. How to store Cetraxal Plus

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use Cetraxal Plus after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
After first opening the bottle, do not use the medicine for longer than 1 month. After opening, store below 25°C.
Medicines must not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 monohydrate and fluocinolone acetonide. 1 ml of Cetraxal Plus contains 3 mg ciprofloxacin (as ciprofloxacin hydrochloride monohydrate) and 0.25 mg fluocinolone acetonide.
• The other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), povidone, ethylene glycol monoethyl ether, glycereth-26 (a compound of glycerine and ethylene oxide), hydrochloric acid and/or sodium hydroxide, and purified water.

What Cetraxal Plus looks like and contents of the pack
Cetraxal Plus is a clear, colourless or slightly yellowish solution for ear drops.
The medicine is packed in a white polyethylene bottle with a polyethylene dropper, closed with a polyethylene cap, and placed in a cardboard box.
Each bottle contains 10 ml of solution.

Advice and medical education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics, it is because they are necessary for treating a specific illness currently affecting the patient.
Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is known as resistance: certain antibiotic treatments become ineffective.
Overuse of antibiotics leads to increased resistance. The patient may even contribute to the development of bacterial resistance, thereby delaying recovery or reducing the effectiveness of the antibiotic, if the following are not properly observed:

• dosage,
• dosing schedule,
• duration of treatment.

Therefore, to ensure effective treatment, you should:

1. Use antibiotics only when prescribed by a doctor.
2. Strictly follow the doctor's instructions.
3. Do not reuse antibiotics without a doctor's prescription, even if you have a similar illness.
4. Never give your antibiotics to another person; they may not be appropriate for treating their condition.
5. After completing treatment, return any unused medicines to a pharmacy for proper disposal.

For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation 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 Alcalá de Henares
Madrid, Spain
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Spanish marketing authorisation number, country of export: 866103.9
Parallel import authorisation number: 392/24
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Spain Cetraxal Plus 3 mg/ml + 0.25 mg/ml gotas óticas en solución
France CETRAXAL 3 mg / 0.25 mg per ml, solution for auricular instillation
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