Cetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops in solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Cetraxal plus 3 mg/ml + 0,25 mg/ml ear drops solution
Ciprofloxacin / Fluocinolone acetonide
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Cetraxal plus is and what it is used for
- What you need to know before using Cetraxal plus
- How to use Cetraxal plus
- Possible adverse effects
- How to store Cetraxal plus
- Contents of the pack and other information
1. What Cetraxal Plus is and what it is used for
Cetraxal Plus is a solution for otic use (in the ear). It contains:
- Ciprofloxacin, which belongs to a group of antibiotics known as fluoroquinolones.
Ciprofloxacin works by eliminating bacteria that cause infections,
- and fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic properties for the treatment of inflammation and pain.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important to follow the instructions regarding dosage, administration interval, and duration of treatment as indicated by your doctor. Do not store or reuse this medication. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medications by flushing them down the drain or throwing them in the trash. |
Cetraxal Plus is an ear drop solution. It is used in adults and children 6 months of age and older to treat acute bacterial external otitis (infection of the outer ear) and otitis media (middle ear infection) with tympanostomy tubes (drainage tubes) of bacterial origin.
You should consult a doctor if your condition worsens or does not improve after completing treatment.
2. What you need to know before using Cetraxal Plus
Do not use Cetraxal Plus:
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If you are allergic to ciprofloxacin, to other quinolones, to fluocinolone acetonide, or to any of the other ingredients of this medicine (listed in section 6).
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If you have an ear infection caused by a virus or a fungus.
Warnings and precautions
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This medicine is for ear use only. It must not be swallowed, injected, or inhaled. It should not be applied to the eye.
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If, after starting treatment, you develop symptoms such as hives (itching) or skin rash, or any other allergic symptoms (for example, sudden swelling of the face, throat, or eyelids, difficulty breathing), stop using the medicine immediately and consult your doctor. Severe hypersensitivity reactions may require immediate emergency treatment.
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Talk to your doctor if your symptoms do not improve before completing the treatment.
As with other antibiotics, infections may sometimes be caused by organisms that are not sensitive to ciprofloxacin. In such cases, appropriate treatment should be prescribed by your doctor.
- Contact your doctor if you experience blurred vision or other visual disturbances.
Children:
There is insufficient clinical experience regarding the use of Cetraxal Plus in children under 6 months of age; therefore, consult your doctor before administering this medicine to your child if they are this age.
Use of Cetraxal Plus with other medicines:
Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or might need to take/use any other medicines, including those obtained without a prescription.
The use of Cetraxal Plus together with other otic (ear) medications is not recommended.
Pregnancy, breastfeeding, and fertility
There are no adequate and well-controlled studies in pregnant women on the teratogenic effects of fluocinolone acetonide.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Caution should be exercised when administering Cetraxal Plus to a breastfeeding woman, as it is not known whether Cetraxal Plus is excreted in human milk.
Driving and use of machines:
Given the characteristics and route of administration of this medicine, Cetraxal Plus does not affect the ability to drive or operate machinery.
Cetraxal Plus contains:
Cetraxal Plus may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
3. How to use Cetraxal Plus
Cetraxal Plus is intended for ear use only (otic use). Follow exactly the instructions for administration of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose in adults and children is 6 to 8 drops twice daily into the affected ear for 7 days.
Administer Cetraxal Plus in both ears only if your doctor has instructed you to do so.
Your doctor will determine the duration of treatment with Cetraxal Plus. To ensure the infection does not return, do not stop treatment early, even if you notice improvement in the ear(s).
Instructions for administration:
The person administering Cetraxal Plus should wash their hands first.
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For patients with a middle ear infection and drainage tubes: While the patient remains lying on their side, the person administering Cetraxal Plus should gently press the skin fold at the entrance of the ear canal (figure 4a) 4 times using a pumping motion. This will help the drops pass through the eardrum and reach the middle ear. For patients with external ear infection: While the patient remains lying on their side, the person administering Cetraxal Plus should gently tug the earlobe forward and backward (figure 4b). This will help the drops penetrate into the ear canal. |
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Keep your head tilted toward the side of the affected ear for about one minute to allow time for the medication to enter the ear.
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Repeat the procedure, if necessary, in the other ear.
It is important that you follow these instructions to achieve a successful outcome with this medication in your ear. Once the medication has been administered into the ear, holding your head upright or moving your head too quickly may cause some of the administered dose to be lost, as the drops may run out of the ear and fail to penetrate into the inner part of the ear canal.
Keep the bottle until completion of treatment. Do not save it for later use.
If you use more Cetraxal Plus than you should
Symptoms related to overdose are not known.
In case of overdose or accidental ingestion, inform your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to use Cetraxal Plus
Do not use a double dose to make up for missed doses. Simply continue with your next scheduled dose.
If you interrupt treatment with 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. If you stop using this medicine too early, the infection may not clear up and symptoms may return or even worsen. Antibiotic resistance may also develop.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Cetraxal plus can cause adverse effects, although not everyone experiences them.
If you experience a severe allergic reaction and develop any of the following symptoms, stop using this medicine immediately and consult your doctor without delay: swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty swallowing or breathing, rashes or hives, sores, ulcers.
Frequent: may affect up to 1 in 10 people
Ear-related effects: Discomfort, pain, itching.
General adverse effects: Taste disturbance.
Uncommon: may affect up to 1 in 100 people
Ear-related effects: Tinnitus (ringing in the ears), medication residue, blockage of the ear drainage tube, tingling, congestion, reduced hearing, skin rash, redness, fungal infection of the outer ear, discharge, inflammation, tympanic membrane disorder, granulation tissue, middle ear infection in the other ear.
General adverse effects: Fungal infection (Candida), irritability, crying, dizziness, flushing, headache, vomiting, fatigue.
Frequency not known (cannot be estimated from available data): Blurred vision.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cetraxal plus
Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
This medicine must be discarded one month after opening. Once opened, store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to your pharmacist for proper disposal. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Cetraxal Plus
- The active substances are ciprofloxacin (as hydrochloride) and fluocinolone acetonide. Each millilitre of Cetraxal Plus contains 3 mg of ciprofloxacin (as hydrochloride) and 0.25 mg of fluocinolone acetonide.
- The other components are methylparaben (E218), propylparaben (E216), povidone, diethylene glycol monoethyl ether, glycereth-26 (a compound of glycerine and ethylene oxide), hydrochloric acid (E507)/sodium hydroxide (E524) and purified water.
Appearance of the product and contents of the pack
Cetraxal Plus is a clear solution in the form of ear drops. It is supplied in opaque white plastic bottles with a dropper. Each pack contains 10 ml of solution.
Marketing Authorisation Holder
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)
or
PHARMALOOP S.L.
C/Bolivia, 15 - Polig. Industrial Azque
28806 Alcala de Henares, Madrid
Spain
This leaflet was approved in June 2019.
This medicinal product is authorised in the European Economic Area (EEA) member states under the following names:
Austria: InfectoCiproCort 3 mg/ml + 0.25 mg/ml Ohrentropfen, Lösung
Germany: InfectoCiproCort 3 mg/ml + 0.25 mg/ml Ohrentropfen, Lösung
Denmark: Cetraxal Comp 3 mg/ml + 0.25 mg/ml Øredråber, opløsning
Slovakia: Infalin duo 3 mg/ml + 0.25 mg/ml Ušná roztoková instilácia
Spain: Cetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops, solution
France: CETRAXAL 3 mg + 0.25 mg per ml, solution for auricular instillation
Finland: Cetraxal Comp 3 mg/ml + 0.25 mg/ml Korvatipat, liuos
Iceland: Cetraxal Comp 3 mg/ml + 0.25 mg/ml Eyrnadropar, lausn
Norway: Cetraxal Comp
Poland: Cetraxal plus
Portugal: Cetraxal Duo 3 mg/ml + 0.25 mg/ml ear drops, solution
Czech Republic: Infalin duo 3 mg/ml + 0.25 mg/ml ušní kapky, roztok
Romania: Cexidal 3 mg/ml + 0.25 mg/ml Picaturi auriculare, solutie
Sweden: Cetraxal Comp 3 mg/ml + 0.25 mg/ml Örondroppar, lösning
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):
http://www.aemps.gob.es/