Cetraxal Otico 3 mg/ml ear drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Cetraxal otic 3 mg/ml ear drops solution
Ciprofloxacin
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 only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Cetraxal otic is and what it is used for
- What you need to know before using Cetraxal otic
- How to use Cetraxal otic
- Possible adverse effects
- How to store Cetraxal otic
- Contents of the pack and other information
1. What Cetraxal Otic is and what it is used for
Cetraxal Otic is an antibiotic belonging to the group of antibiotics known as fluoroquinolones.
It is indicated for the treatment of external otitis (infection of the external ear) caused by microorganisms sensitive to ciprofloxacin.
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 your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the drain or with household waste. |
2. What you need to know before using Cetraxal otic
Do not use Cetraxal otic:
- if you are allergic to ciprofloxacin or other quinolones, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Cetraxal otic.
Other medicines and Cetraxal otic
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Use of Cetraxal otic with food, drinks and alcohol
Not described.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No clinical data are available on this subject. However, due to the route of administration, it is unlikely that this medicine will affect your ability to drive or operate machinery.
Cetraxal otic contains parahydroxybenzoates
May cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
3. How to use Cetraxal otic
Follow exactly the administration instructions for Cetraxal otic provided by your doctor. Consult your doctor or pharmacist if you have any questions. The usual dose is 4–6 drops instilled into the external auditory canal every 8 hours. The duration of treatment will be 7 to 8 days.
If the auditory canal is narrow, you can ensure the medication reaches the eardrum by displacing the canal inferiorly and pulling the auricle outward, so that air bubbles escape and are replaced by the medication.
If you use more Cetraxal otic than you should
There is no available information regarding overdose. In case of accidental ingestion instead of topical application, standard measures should be taken, such as gastric lavage, and you should seek medical attention at a healthcare facility as soon as possible.
In case of overdose or accidental ingestion, consult 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 otic
Do not take a double dose to make up for missed doses.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Cetraxal otic may produce adverse effects, although not everyone experiences them.
Uncommon: may affect up to 1 in 100 people
Itching at the application site (pruritus) may occur, which resolves upon discontinuation of the medication.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 otic
Keep out of the sight and reach of children.
Do not use Cetraxal otic after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Return 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. Additional Information
Composition of Cetraxal Otic
- The active substance is ciprofloxacin.
- The other components are: lactic acid, povidone, anhydrous glucose, propylene glycol, methylparaben (E-218), propylparaben (E-216), hydrochloric acid, purified water.
Appearance of the medicinal product and contents of the container
Solution contained in a 10 ml opaque polyethylene bottle with dropper and tamper-evident cap.
Marketing Authorization 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 Alcalá de Henares
Madrid – Spain
Date of the most recent review of this leaflet: June 1995