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

6.    Further information

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.

•    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.

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 (Stevens-Johnson 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.

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:

Cetraxal 2 mg/ml solution pour instillation auriculaire InfectoCipro 2 mg/ml Ohrentropfen, Losung Cetraxal 2 mg/ml Qtiks^ oTayovs^, SiaXupa UNICEXAL 2 mg/ml gocce auricolari, soluzione Cetraxal 2 mg/ml oordruppels, oplossing

Poland    Cetraxal

United Kingdom    Cetraxal 2 mg/ml ear drops solution

This leaflet was last approved in June 2013.

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