Label: information for the user

CIPROXINA 2 mg/ml + 10 mg/ml eye drops in suspension

ciprofloxacin / hydrocortisone

Read this 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 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 section4.

CIPROXINAcontains two active principles, a corticosteroid anti-inflammatory (hydrocortisone) and an antibiotic (ciprofloxacin); ciprofloxacin is an antibacterial drug from the group known as fluoroquinolones that acts by eliminating the bacteria that cause infections.

This medication is used for the treatment of acute external otitis (ear canal infection) with an intact tympanic membrane in adults and children over 2 years old.

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

Do not use CIPROXINA

• if you are allergic (hypersensitive) to ciprofloxacin or to other medications in the fluoroquinolone group.
• if you are allergic (hypersensitive) to hydrocortisone or to any of the other ingredients listed in section 6.
• if your eardrum is perforated or damaged.
• if you have viral or fungal infections in the ear, including infections caused by the varicella virus or the herpes simplex virus.
• if you have otitis media (a middle ear infection). Symptoms include ear pain, high temperature (fever), and a sensation of blockage in the ears.

Warnings and precautions

• use CIPROXINA only in the ears. Do not inject or ingest this medication.
• if you experience any rash or notice the first signs of a rash on the skin or any other local allergic reaction, including itching, hives, or respiratory problems, stop treatment immediately and consult your doctor.
• with the use of this medication, you may become more sensitive to other infections. Consult your doctor if symptoms and signs persist after one week of treatment.
• the dropper cap contains latex rubber that may cause severe allergic reactions.
• contact your doctor if you experience blurred vision or other visual disturbances.

Children

CIPROXINA is not recommended for children under 2 years of age due to a lack of data in these patients.

Use of CIPROXINA with other medications

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

It is recommended not to apply other ear medications at the same time.

Pregnancy and breastfeeding

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

Driving and operating machinery

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

Ciproxina contains benzyl alcohol

This medication contains 90 mg of benzyl alcohol in each 10 ml bottle, equivalent to 9 mg/ml. Benzyl alcohol may cause allergic reactions and moderate local irritation.

The dropper cap contains latex

The dropper cap contains latex rubber. It may cause severe allergic reactions.

This medication should only be used in the ear. Do not inject or ingest this medication.

Follow exactly the administration instructions for CIPROXINA as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Apply 3 drops in the affected ear canal 2 times a day, in the morning and at night.

The usual duration of treatment is 7 days. If symptoms persist after this time, consult your doctor.

For this medication to be effective, apply it regularly at the prescribed doses and for the indicated period of time by your doctor.

The disappearance of symptoms does not mean you are completely cured. Any feeling of fatigue is not due to the treatment, but to the infection. Reducing the dose or interrupting treatment will not affect this feeling and will only delay recovery.

To properly apply the drops, follow the steps indicated:

1. Wash your hands thoroughly.
2. Remove the cap from the bottle and place the dropper in the bottle.
3. Warm the bottle immediately before use by holding it in the palm of your hand for a few minutes to avoid discomfort when the cold suspension comes into contact with your ears.
4. Shake the bottle before use.
5. With your head tilted to the opposite side of the affected earwith the affected ear directed upwards, apply the drops to the affected ear.
6. With your head still tilted, gently pull the earlobe forward and backward (figure 1). This movement will allow the drops to penetrate the ear canal.

Figure 1

1. Keep your head tilted to that side for about 5 minutes to favor the entry of the drops through the external auditory canal. However, when you lift your head, some drops may spill out of the ear. You can dry them with a non-sterile absorbent paper.
2. Repeat, if necessary, in the other ear.

It is very important to follow these instructions to achieve good efficacy of the medication in the ear. When applying the drops to the ear, it is not recommended to keep your head vertical or move it too quickly, as some drops may spill down your face and not penetrate the ear canal.

Avoid letting the dropper come into contact with your ears or fingers to limit the risk of contamination of the drops.

After completing treatment, dispose of the remaining bottle and do not store it for reuse.

If you use more CIPROXINA 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,apply a single dose as soon as you remember, and continue with the next dose 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 may produce adverse effects, although not everyone will experience them.

The following adverse effects have been observed with CIPROXINA:

Frequent

(may affect up to 1 in 10 people)

Ear effects: ear itching.

Rare

(may affect up to 1 in 100 people)

Ear effects: ear pain, ear congestion, ear discomfort, ear canal redness.

Other effects: dizziness, headache, nausea, skin peeling, fungal skin infection, urticaria, skin rash, itching, abnormal or decreased skin sensation, and presence of medication residue inside or around the ear.

Additional adverse effects were reported for whichfrequency is unknown(cannot be estimated from available data), including:

Ear effects: reduced hearing, tinnitus.

Eye effects:blurred vision

Other effects: allergy.

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 on the safety of this medication.

Keep this medication out of the sight and reach 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.

Do not store at a temperature above 25°C.

Do not refrigerate or freeze.

Store the container within the box to protect it from light.

Keep the container perfectly closed to protect it from moisture.

Once the bottle is opened and the dropper is placed, the drops must be used within the next 14 days.

After completing the treatment, dispose of the remaining contents of the bottle. Do not store it for use on other occasions.

Medications should not be thrown away through the drains or in the trash. Deposit the containers and medications that you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

CIPROXINA Composition

• The active principles are ciprofloxacin 2 mg/ml and hydrocortisone 10 mg/ml.
• The other components are polysorbate 20, sodium acetate, glacial acetic acid, benzyl alcohol, lecithin, sodium chloride, polyvinyl alcohol, and purified water.

Appearance of the product and contents of the packaging

CIPROXINA is a white to off-white liquid (a suspension). It is presented in a box containing a 10 ml glass vial with a polypropylene screw cap and, separately, a dropper (polypropylene pipette, a polypropylene cap, and a latex rubber cap).

Marketing Authorization Holder

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

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: September 2020

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