PACKAGE LEAFLET: INFORMATION FOR THE USER

Unicexal 2 mg/ml ear drops, solution

Ciprofloxacin
Please read this leaflet carefully before using this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Unicexal is and what it is used for
What you need to know before using Unicexal
How to use Unicexal
Possible side effects
How to store Unicexal
Contents of the pack and other information

1. WHAT UNICEXAL IS AND WHAT IT IS USED FOR

Unicexal 2 mg/ml ear drops, solution is a solution for otic use (in the ear) containing ciprofloxacin, the active substance, which is an antibiotic belonging to the group of fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections. Unicexal 2 mg/ml ear drops, solution is indicated in adults and children over one year of age for the treatment of acute bacterial external otitis when the eardrum is still intact (see section 2. What you need to know before taking Unicexal).

2. WHAT YOU SHOULD KNOW BEFORE USING UNICEXAL

Do not use Unicexal:
If you are allergic (hypersensitive) to ciprofloxacin, or to any other antibiotic belonging to the
quinolone class, or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions
If, after starting treatment, you develop hives, a skin rash, or any other allergic symptom (e.g.: sudden swelling of the face, throat, or eyelids, difficulty breathing), stop treatment immediately and consult your doctor.
Severe hypersensitivity reactions may require immediate emergency treatment.
This medicine must be applied exclusively into the ear. It must not be swallowed, injected, or inhaled. It must not be used in the eye.
Inform your doctor if symptoms do not improve within one week of starting treatment.
As with all antibiotics, additional infections caused by organisms not sensitive to ciprofloxacin may occasionally occur. If such infections occur, consult your doctor for appropriate treatment.
Unicexal 2 mg/ml ear drops, solution should be used with caution in patients with known or suspected tympanic membrane perforation, or when there is a risk of perforation of the tympanic membrane.

Other medicines and Unicexal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Concomitant use with another ear preparation is not recommended.

Pregnancy, breastfeeding, and fertility
Unicexal may be used during pregnancy and while breastfeeding.
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
Unicexal does not affect the ability to drive or use machinery.

3. HOW TO USE UNICEXAL

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
This medicine is for ear use only. It must not be swallowed,
injected, or inhaled.

Dosage
The recommended dose for children (one year of age or older) and adults is the contents of one single-dose vial to be administered into the affected ear twice daily for seven days.

Administration
Warm the solution by holding the vial in your hand for several minutes to avoid dizziness that may occur when cold solution is instilled into the ear canal. Lie down with the affected ear facing upward, then instill the drops into the ear canal by repeatedly pulling the earlobe. Remain in this position for about 5 minutes to help the drops flow into the ear. When you sit up again, some drops may leak out. You may gently wipe away these drops with non-sterile absorbent paper. Repeat the procedure, if necessary, for the other ear.

If the ear canal is narrow, gently pull the ear upward to help the medicine flow toward the eardrum.

Following these instructions carefully is extremely important to ensure the medicine works effectively. If drops are administered with the head in an upright position or if the head is moved too quickly afterward, some of the medicine may run out onto the face and fail to reach deep into the ear canal.

Discard the single-dose container after use. Do not store any remaining solution for later use.

If you use more Unicexal than you should
Since this medicine comes as a single-dose preparation, accidental overdose is unlikely. Nevertheless, contact your doctor or pharmacist for advice if you are concerned.

If you forget to use Unicexal
Do not use a double dose to make up for the missed dose.
If you forget to apply the drops, apply the correct dose as soon as you remember. However, if it is nearly time for the next dose, wait and apply the next dose at the scheduled time.

If you stop using Unicexal
It is very important to use these ear drops for the full duration prescribed by your doctor, even if symptoms have improved. Do not stop treatment early, as the infection may return.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Uncommon: may affect less than 1 in 100 people
Itching of the ear, ringing in the ear
Headache
Dizziness
Local skin reactions or irritation (dermatitis)
Pain at the application site
Very rare: may affect less than 1 in 10,000 people
Skin rash
Blister formation and tissue breakdown (toxic epidermolysis)
Redness and peeling of the skin (exfoliative dermatitis)
Severe allergic reactions with fever, red spots, joint pain and/or eye problems (Stevens-Johnson syndrome)
Skin allergies with development of itching and sores (urticaria)
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE UNICEXAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store below 30°C in the original container to protect the product from light.
The contents of the single-dose vial must be used immediately after opening. Any unused portion should be discarded.
Once the aluminium pouch has been opened, use the medicine within 8 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Unicexal contains
The active substance is ciprofloxacin hydrochloride.
1 ml of solution contains 2 mg of ciprofloxacin hydrochloride. Each single-dose vial delivers 0.25 ml of
solution containing 0.58 mg of ciprofloxacin hydrochloride, equivalent to 0.50 mg of ciprofloxacin.
The other components are: povidone-K-90-F (E1201), glycerol (E422), purified water, and sodium
hydroxide (E524) and/or lactic acid (E270) for pH adjustment.

Description of the appearance of Unicexal and contents of the pack
Unicexal is a clear solution for ear drops contained in vials. The vials are packed in a protective aluminium pouch. Each pack contains 15 vials.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany

Manufacturer
Laboratorios SALVAT, S.A.
C/Gall, 30-36.
08950 Esplugues de Llobregat
Barcelona (Spain)

This medicinal product is authorised in the European Economic Area (EEA) Member States
under the following names:
Denmark Cetraxal 2 mg/ml Ear Drops Solution
Finland Cetraxal 2 mg/ml Ear Drops, Solution
France Cetraxal 2 mg/ml solution for auricular instillation
Germany InfectoCipro 2 mg/ml Ear Drops, Solution
Greece Cetraxal 2 mg/ml Ωτικές σταγόνες, διάλυμα
Iceland Cetraxal 2 mg/ml eyrnadropar, lausn
Italy Unicexal 2 mg/ml ear drops, solution
Netherlands Cetraxal 2 mg/ml oordruppels, oplossing
Norway Cetraxal
Poland Cetraxal
Sweden Cetraxal 2 mg/ml örondroppar, lösning
United Kingdom Cetraxal 2 mg/ml ear drops solution