Ciproxina Simple 3 mg/ml ear drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
CIPROXINA Simple 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, 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 effects not listed in this leaflet.
Leaflet contents
- What CIPROXINA Simple is and what it is used for
- What you need to know before using CIPROXINA Simple
- How to use CIPROXINA Simple
- Possible side effects
- How to store CIPROXINA Simple
- Contents of the pack and other information
1. What CIPROXINA Simple is and what it is used for
CIPROXINA Simple contains an antibiotic (ciprofloxacin) that belongs to a group of medicines called quinolones.
Antibiotics are used to treat bacterial infections and are not effective against viral infections.
It is important that you follow the instructions regarding dosage, dosing interval, and duration of treatment as indicated by your doctor.
Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
This medicine is used for the treatment of acute external otitis.
2. What you need to know before using CIPROXINA Simple
Before prescribing this medicine, your doctor will have examined your eardrums to ensure they are not perforated.
Do not use CIPROXINA Simple
If you are allergic to ciprofloxacin, to other medicines in the quinolone group, or to any of the other components of this medicine (listed in section 6).
If you have a perforated or damaged eardrum.
Warnings and precautions
Consult your doctor or pharmacist before starting to use CIPROXINA Simple.
- Use this medicine only in your ear(s).
- If you experience early signs of a skin rash or any other hypersensitivity reaction, including rash, itching, or breathing difficulties, stop treatment and contact your doctor immediately. If you have a severe allergic reaction, you may require emergency treatment.
- If your symptoms worsen or return, consult your doctor. With use of this medicine, you may become more susceptible to other infections, particularly after prolonged use.
- If you are elderly or taking medicines called corticosteroids used to treat conditions such as pain and inflammation, asthma, or skin problems, you have a higher risk of tendon problems during treatment with this medicine. If you experience any swelling or inflammatory condition, stop treatment and contact your doctor immediately.
- If you experience pain, swelling, or inflammation of the tendons during or shortly after using these drops, stop treatment and consult your doctor.
- Close medical monitoring is necessary.
- If you notice increased sensitivity to sunlight, such as sunburn, you should also stop treatment.
- CIPROXINA Simple may also be used in children under 1 year of age for the treatment of acute external otitis, when considered necessary by your doctor.
- If you are in any of the following situations, you may have an increased risk of tendon problems:
- Advanced age.
- Treatment with steroids.
Using CIPROXINA Simple with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding, and fertility
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.
This medicine is not recommended during pregnancy. Do not use CIPROXINA Simple during pregnancy or breastfeeding unless your doctor considers it necessary.
If you are breastfeeding, do not use this medicine as it may pass into breast milk.
Driving and using machines
Treatment with this medicine does not affect the ability to drive or operate machinery.
CIPROXINA Simple contains benzalkonium chloride
This medicine contains 0.06 mg of benzalkonium chloride per ml.
Benzalkonium chloride may cause skin irritation. Do not apply to mucous membranes.
3. How to use CIPROXINA Simple
This medicine must only be administered by the otic route, that is, as ear drops. Always follow the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Follow these instructions unless your doctor has given you different ones (such as when using an otowick, a sponge placed in the ear in some cases of external otitis to facilitate absorption of the drops).
Remember to take your medicine at the scheduled time.
Your doctor will determine the duration of treatment with these drops. Do not stop treatment early, as this could negatively affect the healing process of the affected ear.
Recommended dose:
Adults: 4 drops into the ear, twice daily, morning and night.
Children: 3 drops into the ear, twice daily, morning and night.
Instructions for use:
Figure 1 Figure 2
- Wash your hands.
- Take the bottle and hold it in your hand for a few minutes to warm the contents and prevent the drops from being too cold when entering the ear.
- Unscrew the cap.
- Hold the bottle upside down between your fingers.
- Lie on your side with the affected ear facing upward (Figure 1).
- Bring the tip of the bottle close to the ear canal.
- Do not touch the ear, ear canal, surrounding areas, or any other surfaces with the dropper tip, as this may contaminate the drops.
- Gently squeeze the base of the bottle so that one drop of medicine falls at a time.
- Do not squeeze the bottle forcefully: it is designed so that light pressure on the base is sufficient (Figure 2). Adults should apply 4 drops and children 3 drops.
- Keep your head tilted to that side for about 5 minutes to help the drops enter the external ear canal.
- If drops are to be applied to both ears, repeat the above steps for the other ear.
- Close the bottle tightly immediately after use.
If a drop misses the ear, try again.
If you are using other ear drops, wait at least 5 minutes between the application of CIPROXINA Simple and the other drops.
If you use more CIPROXINA Simple than you should, do not apply additional drops until your next scheduled dose.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at phone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use CIPROXINA Simple, apply a single dose as soon as you remember, and then continue with your next scheduled dose. However, if it is almost time for your next dose, do not apply the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, CIPROXINA Simple can cause adverse effects, although not everyone experiences them.
Uncommon adverse effects (may affect up to 1 in 100 people):
- Ear-related effects: pain, congestion, discharge, itching.
- General effects: headache, skin swelling, fever.
Adverse effects of unknown frequency (cannot be estimated from available data):
- Ear-related effects: tinnitus.
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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of CIPROXINA Simple
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the outer carton, following "EXP". The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Do not refrigerate or freeze.
Keep the bottle tightly closed.
To prevent infections, the bottle must be discarded 4 weeks after first opening.
Record the date you opened the bottle in the space provided for this purpose on the carton.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of CIPROXINA Simple
- The active substance is ciprofloxacin. Each ml of solution contains 3 mg of ciprofloxacin (as hydrochloride).
- The other components are benzalkonium chloride, sodium acetate trihydrate, glacial acetic acid, mannitol (E-421), disodium edetate, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.
Appearance of the product and contents of the container
CIPROXINA Simple is an otic solution presented in 5 ml plastic bottles with screw caps.
Marketing Authorization Holder
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 – Barcelona, Spain
Manufacturer
Novartis Manufacturing NV
Rijksweg, 14
2870 Puurs-Sint-Amands, Belgium
or
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona, Spain
Date of the most recent revision of this leaflet: April 2013
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/