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CETRAXAL 2MG/ML EAR DROPS SOLUTION

Active substance(s): CIPROFLOXACIN HYDROCHLORIDE

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PACKAGE LEAFLET

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Cetraxal 2 mg/ml ear drops solution
Ciprofloxacin
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Cetraxal is and what it is used for
2.
Before you use Cetraxal
3.
How to use Cetraxal
4.
Possible side effects
5.
How to store Cetraxal
Further information
6.
1.

WHAT CETRAXAL IS AND WHAT IT IS USED FOR

Cetraxal 2 mg/ml ear drops solution is a solution for auricular use (in the ear) that contains
ciprofloxacin, the active substance which is an antibacterial agent belonging to the group of
fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections. Cetraxal 2 mg/ml
ear drops solution is used for the treatment of acute external otitis (inflammation or infection of the
external auditory canal) of bacterial origin where the eardrum is still intact (see section 2. Before
you use Cetraxal).
The name of your medicine is ‘Cetraxal 2 mg/ml ear drops solutions’, but will be referred to as
‘Cetraxal’ throughout the rest of this leaflet.
2.

BEFORE YOU USE CETRAXAL

Do not use Cetraxal

if you are allergic (hypersensitive) to ciprofloxacin, to any member of the quinolone class of
antimicrobial agents or any of the other ingredients of Cetraxal.
Take special care with Cetraxal

Once treatment has begun, if you develop urticaria (hives), skin rash or any other allergic
symptoms (e.g. sudden swelling of face, throat or eyelids, breathing difficulty), you must
stop treatment immediately and you should consult with your doctor. Serious
hypersensitivity reactions may need immediate emergency treatment.

This preparation should only be applied to the ear. It should not be swallowed, injected or
inhaled. It should not be used in the eye.

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Tell the doctor if the symptoms do not improve within one week of starting treatment.
As with all antibiotics, sometimes additional infections may occur caused by organisms
which are not affected by ciprofloxacin. In case of such infection appropriate treatment
should be started by your doctor.
Cetraxal 2 mg/ml ear drops solution should be used with caution in patients with known or
suspected perforation, or where there is a risk of perforation of the tympanic membrane (ear
drum).

Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. The use in conjunction with other ear preparations is not
recommended.
Pregnancy and breast-feeding
Cetraxal can be used during pregnancy and during breast-feeding.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Cetraxal does not affect the ability to drive vehicles or operate dangerous machinery.
3.

HOW TO USE CETRAXAL

This medicine is intended to be administered into the ear. It should not be swallowed, injected or
inhaled.
Always use Cetraxal exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure
Dosage
For children (age 1 year and older) and adults, the contents of 1 single ampoule should be instilled
into the affected ear twice daily for seven days.
Administration
Warm the solution, by holding the ampoule in the hand for several minutes, to avoid the dizziness
that may result from the instilation of a cold solution into the ear canal. Lie with the affected ear
upward and then instil the drops pulling several times on the auricle (outside of the ear). Maintain
the position for around 5 minutes, to facilitate penetration of the drops into the ear. When you stand
up again, some drops may run down your face. You can dry them with a non sterile absorbent
paper. Repeat, if necessary, for the opposite ear.
If the auditory canal is narrow, the medicine can be made to reach the eardrum by pulling the ear
upwards.
It is most important to follow these instructions in order that this medicine works effectively. When
you instil ear drops, maintaining your head vertically or moving your head too rapidly this may lead
to a loss of part of the drug as the drops may run down your face or fail go deep into the ear.
Discard the single-dose container after the use. Do not keep it for subsequent use.

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If you use more Cetraxal than you should
Since this 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 Cetraxal
Do not take a double dose to make up for a forgotten dose.
If you forget to apply your drops, apply the correct dose when you remember or if it is close to your
next application then wait until this time.
If you stop using Cetraxal
It is very important to use these eardrops for as long as the doctor has instructed, even if the
symptoms improve. Do not interrupt your treatment before time, as the infection could return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Cetraxal can cause side effects, although not everybody gets them.
Uncommon side effects (affecting at least 1 in 1000 people):

Ear pruritus (itching), ringing in the ears.

Headache
Dizziness


Local skin reactions or irritation (Dermatitis)

Pain at the application site
Very rare side effects (affecting less than 1 in 10,000 people):

Rash

Blistering and tissue break down (Toxic epidermolysis)

Redness and scaling of the skin (Exfoliative dermatitis)

Serious allergic reaction with fever, red patches, joint pain and/or eye problems (StevensJohnson syndrome)
Skin allergy with development of itchiness and weals or raised bumps on the skin (Urticaria)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5.

HOW TO STORE CETRAXAL

Keep out of the reach and sight of children.
Store below 30°C in the original package in order to protect from light.
Do not use Cetraxal after the expiry date stated on the package. The expiry date refers to the last
day of that month.
The ampoule contents should be used immediately after opening the single dose ampoule. Any
unused contents should be discarded.

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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.
Once the pouch is opened, use within 8 days.
6.

FURTHER INFORMATION

What Cetraxal contains
-

The active substance is ciprofloxacin as hydrochloride
The other ingredients are povidone-K-90-F (E1201), glycerol (E422), purified water, sodium
hydroxide (E524) and lactic acid (E270) for pH-adjustment.

1 ml solution contains 2 mg of ciprofloxacin as hydrochloride. Each ampoule delivers 0.25 ml of
solution that contains 0.58 mg of ciprofloxacin hydrochloride corresponding to 0.50 mg of
ciprofloxacin.
What Cetraxal looks like and contents of the pack
Cetraxal is a clear ear drop solution contained in ampoules. The ampoules are packed in an
aluminium foil overwrap pouch for protection. Each pack contains 15 ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios SALVAT, S.A.
C/ Gall, 30-36.
08950 Esplugues de Llobregat
Barcelona (Spain)
Manufacturer
Laboratorios SALVAT, S.A.
C/ Gall, 30-36.
08950 Esplugues de Llobregat
Barcelona (Spain)
Manufacturer only for the German Market
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany
www.infectopharm.com
This medicinal product is authorised in the Member States of the EEA under the following
names:
France
Germany
Greece
Italy
The Netherlands

Cetraxal 2 mg/ml solution pour instillation auriculaire
InfectoCipro 2 mg/ml Ohrentropfen, Lösung
Cetraxal 2 mg/ml Ωτικές σταγόνες, διάλυμα
UNICEXAL 2 mg/ml gocce auricolari, soluzione
Cetraxal 2 mg/ml oordruppels, oplossing
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Poland
United Kingdom

Cetraxal
Cetraxal 2 mg/ml ear drops solution

This leaflet was last approved in June 2013.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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