Prospect: information for the user

CIPROXINA Simple 3 mg/ml eye drops in solution

Ciprofloxacin

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they 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 prospect.

1. What is CIPROXINA Simple and for what it is used

2. What you need to know before starting to use CIPROXINA Simple

3. How to use CIPROXINA Simple

4. Possible adverse effects

5. Storage of CIPROXINA Simple

6. Contents of the package and additional information

CIPROXINA Simple contains an antibiotic (ciprofloxacin) that belongs to a group of medicines called quinolones.

This medication is used for the treatment of acute external otitis.

Before prescribing this medication, your doctor will have examined your eardrums to ensure they are not perforated.

Do not use CIPROXINA Simple

If you are allergic to ciprofloxacin, other quinolone medications, or any of the other components of this medication (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 medication only in your ear(s).
• If you experience the first signs of a skin rash or any other hypersensitivity reaction, including itching, hives, or respiratory problems, discontinue treatment and consult your doctor immediately. If you suffer a severe allergic reaction, you may need emergency treatment.
• If your symptoms worsen or return, consult your doctor. You may become more sensitive to other infections, especially after long-term use of this medication.
• If you are elderly or using medications called corticosteroids, which are 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 medication. If you experience any inflammation or inflammatory conditions, discontinue treatment and consult your doctor immediately.
• If you experience pain, swelling, or inflammation of the tendons during or shortly after using these drops, discontinue treatment and consult your doctor.
• Careful medical monitoring is necessary.
• If you notice an excessive sensitivity to sunlight in the form of sunburn, you should also discontinue treatment.
• CIPROXINA Simple may also be used in children under 1 year for the treatment of acute otitis externa, when your doctor deems it necessary..
• If you are in one of these situations, you may have a higher risk of tendon problems:
• • Advanced age.
  • Treatment with steroids.

Use of CIPROXINA Simple with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended during pregnancy. Do not use CIPROXINA Simple during pregnancy or breastfeeding, unless your doctor deems it necessary.

If you are breastfeeding your baby, do not use this medication as it may pass into breast milk.

Driving and operating machinery

The treatment with this medication does not affect your ability to drive and operate machinery.

CIPROXINA Simple contains benzalkonium chloride

This medication contains 0.06 mg of benzalkonium chloride per ml.

Benzalkonium chloride may cause skin irritation. Do not apply to mucous membranes.

This medicationshould onlybe administered via the otic route, that is, as ear drops. Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of 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 the absorption of the drops).

Remember to apply your medication when it is due.

Your doctor will indicate the duration of treatment with these drops. Do not suspend treatment beforehand, as it could harm the evolution of the healing of the affected ear.

The recommended dose is:

Adults: 4 drops in the ear, twice a day, morning and night.

Children:3 drops in the ear, twice a day, morning and night.

Usage recommendations:

Figure 1Figure 2

1. Wash your hands.
2. Take the bottle and hold it in your hand for a few minutes to temper the contents and avoid the drop being too cold when it enters your ear.
3. Remove the cap.
4. Hold the bottle upside down between your fingers.
5. Lie on your side with the affected ear facing upwards (Figure 1).
6. Bring the tip of the bottle to the auditory canal.
7. Do not touch the ear, the auditory canal, nearby areas, or other surfaces with the dropperbecause the drops could become infected.
8. Gently press the base of the bottle to allow one drop of medication to fall each time.
9. Do not squeeze the bottle:it is designed to require only a gentle pressure on the base (Figure 2). Adults should apply 4 drops and children 3 drops.
10. Keep your head tilted to that side for about 5 minutes to favor the entry of the drops through the external auditory canal.
11. If drops are applied to both ears, repeat the previous steps for the other ear.
12. Close the bottle tightly immediately after using the product.

If a drop falls outside 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 more drops until the next dose.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use CIPROXINA Simple,apply a single dose as soon as you remember, and continue with the next dose that was scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen. Do not apply 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.

Like all medications, CIPROXINA Simple may produce adverse effects, although not all people will experience them.

Less common adverse effects (may affect up to 1 in 100 people):

• Ear effects: pain, congestion, discharge, itching.
• General effects: headache, skin inflammation, fever.

Adverse effects of unknown frequency (cannot be estimated from available data):

• Ear effects: ringing.

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 can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the reach and sight of children.

Do not use this medication after the expiration date that appears on the bottle and on the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not refrigerate or freeze.

Keep the bottle tightly closed.

To avoid infections, dispose of the bottle 4 weeks after first opening it.

Note the date of bottle opening in the designated space on the box.

Medications should not be disposed of through drains or trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of CIPROXINA Simple

• The active ingredient 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, chlorhydric acid and/or sodium hydroxide (to adjust the pH) and purified water.

Appearance of the product and contents of the packaging

CIPROXINA Simple are eye drops in solution that are presented in 5 ml plastic bottles with screw-top caps.

Holder of the marketing authorization

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona, Spain

Responsible for manufacturing

Siegfried El Masnou, S.A.

C/Camil Fabra, 58

08320 El Masnou – Barcelona, Spain

or

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

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg, Germany

Last review date of this leaflet: April 2013

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/