UNICEXAL 2 mg /Ml Ear Drops, Solution

Зміст інструкції

1. Unicexal 2 mg/ml ear drops, solution
   1. WHAT IS UNICEXAL AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE UNICEXAL
   3. HOW TO TAKE UNICEXAL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE UNICEXAL
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Unicexal 2 mg/ml ear drops, solution

Ciprofloxacin

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Unicexal is and what it is used for
• 2. What you need to know before you use Unicexal
• 3. How to use Unicexal
• 4. Possible side effects
• 5. How to store Unicexal
• 6. Contents of the pack and other information

1. WHAT IS UNICEXAL AND WHAT IS IT USED FOR

Unicexal 2 mg/ml ear drops, solution is a solution for auricular use (in the ear) that
contains ciprofloxacin, the active ingredient which is an antibiotic belonging to the group of
fluoroquinolones. Ciprofloxacin works by killing the 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 where the tympanic membrane is still intact (see
section 2. What you need to know before you use Unicexal)

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE UNICEXAL

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

Warnings and precautions
If, once started treatment, you experience urticaria, rash or any other allergic symptoms (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 to the ear. It must not be
swallowed, injected or inhaled. It must not be used in the eye.
Inform your doctor if your symptoms do not improve within one week of starting treatment.
As with all antibiotics, additional infections caused by
organisms that are not sensitive to ciprofloxacin may sometimes occur. In case of such infections, contact
your doctor to start appropriate treatment.
Unicexal 2 mg/ml ear drops, solution must be used with caution in patients with
known or suspected tympanic perforation, or where there is a risk of perforation of the tympanic
membrane.

Other medicines and Unicexal
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines. Concomitant use with another
ear preparation is not recommended.

Pregnancy, breastfeeding and fertility
Unicexal can be used during pregnancy and during breastfeeding.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Unicexal does not affect the ability to drive vehicles or operate dangerous machinery.

3. HOW TO TAKE UNICEXAL

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, ask your doctor or pharmacist.
This medicine must be applied exclusively to the ear. It must not be swallowed,
injected or inhaled.
Dosage
The recommended dose, for children (one year of age or older) and adults, is the content of one
single-dose vial which must be applied to the ear affected by the infection twice a day for seven
days.
Administration
Warm the solution by holding the vial in your hand for a few minutes, to avoid the dizziness that may
result from instilling cold solution into the ear canal. Lie down so that the ear affected by the
infection is facing upwards, then instill the drops into the ear canal by pulling the earlobe several
times. Maintain this position for about 5 minutes, to facilitate the flow of the drops into the ear.
When you raise your head, some drops may leak out. You can dry these drops with non-sterile paper
towel. Repeat, if necessary, the operation for the opposite ear.
If the ear canal is narrow, the medicine can be facilitated to flow towards the eardrum by pulling
the ear upwards.
Following these instructions is of the utmost importance to achieve good efficacy of the
medicine in the ear. When instilling drops into the ears while keeping the head in a
vertical position or moving the head too quickly, there is a risk of losing some of the medicine
because the drops run down the face and do not reach the ear canal in depth.
Dispose of the single-dose container after use. Do not store any remaining solution for
later use.

If you take more Unicexal than you should
Since this medicine is a single-dose preparation, an accidental overdose is
unlikely. In any case, you should contact your doctor or pharmacist for advice.

If you forget to use Unicexal
Do not use a double dose to make up for a missed dose.
If you forget to apply the drops, apply the correct dose when you remember or, if it is close
to the time of the next application, wait until then.

If you stop taking Unicexal
It is very important to use these ear drops for the entire time prescribed by your doctor,
even if the symptoms have improved. Do not stop therapy prematurely, as
the infection may recur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon: may affect less than 1 in 100 people
Ear itching, tinnitus
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
Blistering and breaking of the tissue (toxic epidermal necrolysis)
Redness and scaling of the skin (exfoliative dermatitis)
Severe allergic reactions with fever, red spots, joint pain and/or eye problems (Stevens-Johnson Syndrome)
Skin allergies with the development of itching and sores (urticaria)
If any of these side effects gets worse, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects 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 at a temperature 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
contents must be discarded.
Once the aluminium pouch is opened, use the medicine within 8 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Unicexal contains
The active ingredient 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 ingredients 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 of ear drops contained in vials. The vials are packaged
in a protective aluminum 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 Member States of the European Economic Area (EEA)
under the following denominations:
Denmark Cetraxal 2 mg/ml Øredråberopløsning
Finland Cetraxal 2 mg/ml Korvatipat, liuos
France Cetraxal 2 mg/ml solution for auric instillation
Germany InfectoCipro 2 mg/ml Ohrentropfen, Lösung
Greece Cetraxal 2 mg/ml Ωτικέςσταγόνες, 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 eardropssolution