Cetraxal otico 3 mg/ml gotas oticas en solucion
Introduction
Label: Information for the User
Cetraxal Otic 3 mg/ml Otic Drops in Solution
Ciprofloxacin
Read this entire label carefully before starting to use this medication, as it contains important information for you.
- Keep this label, as you may need to refer to it again.
- If you have any questions, consult your doctor or pharmacist.
- This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
1. What is Cetraxal otico and what is it used for
Cetraxal otico is an antibiotic that belongs to the group of antibiotics known as fluoroquinolones.
It is indicated for external otitis (infection of the outer ear) caused by microorganisms sensitive to ciprofloxacin.
Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold. It is essential that you follow the instructions regarding the dose, administration interval, and duration of treatment indicated by your doctor. Do not store or reuse this medication. If you have leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash. |
2. What you need to know before starting to use 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 medication (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Cetraxal otic.
Other medications and Cetraxal otic
Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.
Use of Cetraxal otic with food, drinks and alcohol
No information is available.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.
Driving and operating machinery
No clinical data is available. However, given the route of administration, it is unlikely that this medication will affect your ability to drive vehicles or operate machinery.
Cetraxal otic contains parahydroxybenzoates
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
3. How to use Cetraxal otic
Follow exactly the administration instructions for Cetraxal otic as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. The normal dose is 4-6 drops instilled into the external auditory canal, every 8 hours. The treatment duration will be 7 to 8 days.
If the auditory canal is narrow, the medication is made to reach the eardrum by displacing the canal from its lower part and then pulling the eardrum, so that when the air bubbles come out, they are replaced by the medication.
If you use more Cetraxal otic than you should
No information is available regarding overdosing. In case of accidental ingestion, instead of topical application, routine measures should be taken, such as gastric lavage, and seek medical attention as soon as possible.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to use Cetraxal otic
Do not take a double dose to compensate for the missed doses.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medications, Cetraxal otic may produce adverse effects, although not all people will experience them.
Rare: may affect up to 1 in 100 people
Itching at the application site (pruritus) may occur, which resolves upon discontinuation of the medication.
Reporting 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 prospectus. You may also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.
By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
5. Cetraxal Otic Storage
Keep out of sight and reach of children.
Do not use Cetraxal Otic after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.
Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines atthe pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.
6. Additional Information
Cetraxal Otic Composition
- The active ingredient is ciprofloxacin.
- The other components are: lactic acid, povidone, anhydrous glucose, propylene glycol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), hydrochloric acid, purified water.
Product Appearance and Packaging Contents
Preconditioned solution in a 10 ml opaque polyethylene container provided with a dropper and a tamper-evident cap.
Marketing Authorization Holder
Laboratorios Salvat, S.A.
C/ Gall, 30-36 - 08950
08950 Esplugues de Llobregat
Barcelona - Spain
Responsible for Manufacturing
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
Last Review Date of this Leaflet:June 1995
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