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CILODEX 3 MG/ML / 1 MG/ML EAR DROPS SUSPENSION

Active substance(s): CIPROFLOXACIN HYDROCHLORIDE / DEXAMETHASONE

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KAPVORM

PMS ZWART
à 100   % - 20  %

75020-0

Package leafet  : Information for the user

CILODEX

®

3 mg / ml  /  1 mg / ml ear drops, suspension

Ciprofloxacin  /  dexamethasone
Read all of this leaflet carefully before
you start using this medicine because
it contains important information for
you.
-- 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
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
-- If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.

1

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

What CILODEX is and what it is used for

CILODEX is a suspension for auricular use ( in the
ear ). It contains  :
-- ciprofloxacin, an antibiotic belonging to the
group fluoroquinolones. Ciprofloxacin works by
killing bacteria that cause infections
-- and dexamethasone, a corticosteroid or antiinflammatory agent that will help to relieve
inflammation and redness.

2

What is in this leaflet  :

CILODEX is an ear drop. This medicine is used to
treat acute middle ear infection ( otitis media ) in
patients with draining ear tubes ( tympanostomy
tubes or “Grommets” ) or to treat an outer ear
infection ( acute otitis externa ). It has been shown
to be safe and effective in paediatric patients
6 months of age and older for the treatment of
middle ear infections ( AOMT ) and 1 year of age
and older for the treatment of outer ear infections
( AOE ).

What you need to know before you use CILODEX

Do not use CILODEX  :
-- If you are allergic to ciprofloxacin,
dexamethasone or any of the other ingredients
of this medicine ( listed in section 6 ).
-- If you are allergic to medicines called
quinolone antibiotics, as this medicine may
cause the same allergy
-- If you have an ear infection caused by a virus
or fungus

Warnings and precautions
Talk to your doctor or pharmacist before using
CILODEX.
-- This preparation should only be applied to the
ear. It is not for use in the eye and should not
be swallowed, injected or inhaled.
-- Once treatment has begun, if you notice
the first signs of a skin rash or any other
allergic symptoms ( e.g. urticaria ( hives ),
sudden swelling of face, throat or eyelids,
breathing problems ), you must stop treatment
immediately and you should consult with your
doctor. Serious allergic reactions may need
immediate emergency treatment.
-- Tell the doctor if the symptoms do not
improve within one week of starting treatment,
get worse or suddenly return. 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.

-- If you feel pain, swelling or inflammation of
the tendons while, or soon after taking this
medicine, stop treatment and contact your
doctor. Pay special attention if you are over
65 years old or being treated with
corticosteroids.
-- Use in children  : There is insufficient clinical
experience available on the use of CILODEX
in children below 6 months in the treatment of
middle ear infections and in children younger
than 1 year in the treatment of outer ear
infections, so talk to your doctor before giving
this medicine to your very young child if your
child has these ages.
If any of these apply ask your doctor for
advice.

Other medicines and CILODEX
Tell your doctor or pharmacist if you are using
or have recently used or might use any other
medicines.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
might be pregnant or are planning to have a
baby, ask your doctor for advice before taking
this medicine.

Driving and using machines
There are no known effects of CILODEX on the
ability to drive or use machines.

This medicine contains
benzalkonium chloride
which is a known irritant and may cause local
skin reactions.

3

How to Use CILODEX

Always use this medicine exactly as your doctor
has told you. Check with your doctor if you are
not sure.
The recommended dose for adults and
children is 4 drops in the ear canal, twice a
day – morning and evening for 7 days. This
medicine is intended to be administered into the
ear ( auricular use ) only.

2. Warm & shake the bottle
The person giving CILODEX should hold the
bottle in their hand( s ) for several minutes to
warm the ear drops ( picture 1 ) to avoid the
dizziness that may result from the instillation
of a cold solution into the ear canal, then
shake the bottle well before use.

Remove the loose collar from the cap when
the bottle is first opened.
Your doctor will tell you how long your treatment
with this medicine will last. To make sure that
the infection does not return, do not stop
treatment early, even if your ear( s ) feel better.
Only use this medicine in both ears if your doctor
told you to do so.

3. Give drops
The patient should lie with the infected ear
upward ( picture 2 ).

Instructions for Use
It is best if another person can put the
drops in for you. Children should never be
allowed to put the drops in themselves.
1. Wash hands
The person giving CILODEX should wash
his / her hands with soap and water.



Put 4 drops of CILODEX into the infected ear
( picture 3 ). Do not touch the fingers or the
ear or any other surfaces with the tip of the
bottle as it could infect the drops.



After putting in the drops follow the
instructions below for the patient’s specific
ear infection.

Continued over

InDesign CS4

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the legal rules. Please also carefully check: local barcodes if any, formula, shelflife if
mentioned, storage conditions and trademarks.

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How to Use CILODEX ( continued )

4. For patients with middle ear infection
with draining ear tubes ( tympanostomy
tubes or “Grommets” )  :
While the patient lies on his / her side, the
person giving CILODEX should gently press
the flap of skin at the entrance to the ear canal
( picture 4 ) 5 times in a pumping motion. This
will allow the drops to pass through the tube
in the eardrum and into the middle ear.

It is of the utmost importance to follow this
instruction to achieve good efficacy of the
drug in your ear. When you instil ear drops,
keeping your head vertical or moving your
head too rapidly constitute factors for losing
a part of the drug because drops are going to
run down onto your face and do not go into
the depths of the auditory canal.
Keep the bottle tightly closed when not in use.
Keep the bottle until the completion of the
treatment. Do not keep it for subsequent use.
When applying the medicine, be careful that
the dropper does not come into contact
with your ear or your fingers so as to avoid
contamination.

5. For patients with outer ear infection.
While the patient lies on his / her side, the
person giving CILODEX should gently pull
the outer ear lobe upward and backward
( picture 5 ). This will allow the ear drops to flow
down into the ear canal.

Repeat Steps 2-5 for the other ear if both ears
are infected.
If you use more medicine than you should,
please tell your doctor or pharmacist.
If you forget to use this medicine do not
worry, just continue with your next dose. Do
not use a double dose to make up for a
forgotten dose.
If you stop using CILODEX
Do not stop using this medicine without telling
your doctor or pharmacist. If your ear( s ) do not
feel better after 1 week of treatment go back
to your doctor.

6. Stay on side
The patient should remain on his / her side
around 5 minutes to facilitate penetration of
the drops into the ear.

If you have any further questions on the use
of this medicine, ask your doctor or pharmacist.

When you raise your head up again, some
drops can run out. You can dry them with a
non-sterile absorbent paper.

4

Possible Side Effects

Like all medicines, CILODEX can cause side
effects, although not everybody gets them.

Rare side effects : May affect up to 1 in
1000 people

If you experience a severe allergic reaction
and any of the following, stop taking this
medicine and tell your doctor immediately  :
swelling of hands, feet, ankles, face, lips, mouth
or throat, difficulty in swallowing or breathing,
rash or hives, sores, ulcers.

Effects in the ear : reduced hearing, ringing in the
ears, medication residue.

Common  : May affect up to 1 in 10 people
Effects in the ear  : ear pain.

General side effects : dizziness, headache,
redness in ear.
The following side effects have been seen with
CILODEX Ear Drops. Frequency cannot be
estimated from the available data  :
Effects in the ear  : ear inflammation

Uncommon  : May affect up to 1 in
100 people

General side effects  : allergy

Effects in the ear  : ear discomfort, blockage of
tube draining the ear, tingling, ear congestion,
itchy ear, fungal infection of outer ear, ear
discharge, scaling in ear.
General side effects  : Candida infection, irritability,
crying, flushing of skin, vomiting, bad taste,
tiredness.

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 via the national
reporting system ( see details below ).
By reporting side effects you can help provide
more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website  : www.mhra.gov.uk / yellowcard

5

How to Store CILODEX

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the bottle and the carton. The
expiry date refers to the last day of that month.
Do not freeze.

6

Keep the bottle in the outer carton in order to
protect from light.
Discard the bottle 4 weeks after first
opening.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.

Contents of the pack and other information

What CILODEX contains
The active substances are ciprofloxacin and
dexamethasone.
Each 1 ml of suspension contains
3 mg ciprofloxacin as hydrochloride and
1 mg dexamethasone
The other ingredients are benzalkonium chloride,
hydroxyethyl cellulose, sodium acetate trihydrate,
acetic acid, sodium chloride, disodium edetate,
tyloxapol, boric acid, hydrochloride acid  /  sodium
hydroxide ( for pH-adjustment ), purified water.
What CILODEX looks like and contents of
the pack
CILODEX is a white to off-white uniform
suspension supplied in a pack containing a 5-ml
bottle ( LDPE ) with a white ( PP ) closure.
Marketing Authorisation Holder
Alcon Laboratories ( UK ) Ltd.
Frimley Business Park,
Frimley, Camberley,
Surrey, GU16 7SR.
United Kingdom.
Manufacturer
S.A. Alcon-Couvreur N.V.
Rijksweg 14, B-2870 Puurs
Belgium
This leaflet was last revised in
February 2015

Advice / medical education
Antibiotics are used to cure bacterial infections.
They are ineffective against viral infections. If
your doctor has prescribed antibiotics, you need
them precisely for your current illness. Despite
antibiotics, some resistant bacteria may survive
or grow  ; therefore, some antibiotic treatment
may not be effective. Misuse of antibiotics may
increase resistance. You may even help bacteria
become resistant and therefore delay your cure
or decrease antibiotic efficacy if you do not
respect appropriate  :
-- dosages,
-- schedules,
-- duration of treatment.
Consequently, to preserve the efficacy of
this drug  :
1. Use antibiotics only when prescribed.
2. Strictly follow the prescription.
3. Do not re-use an antibiotic without medical
prescription, even if you want to treat a similar
illness.
4. Never give your antibiotic to another person  ;
maybe it is not adapted to his / her illness.
5. After completion of treatment, return all
unused drugs to your chemist’s shop to
ensure they will be disposed of correctly.

®
© 2015 Novartis
12-2014

75020-0

InDesign CS4

140 x 504  /  140 x 22 mm

Cilodex Suspension 5 ml

recto-verso

GB

AANTAL KLEUREN   : 1

WS

29-01-2015

Local
Graphics

-DRAFT-

BESOP-00326

Affiliates

BELGIUM 75020-0

Approval

V1

Ready for sending:

as is.

new proof.

Final release:

as is.

new proof.

With approval in Catalyst you confirm that this proof contains an accurate translation of the
English Corporate Standard text, and is in compliance with the registered information and
the legal rules. Please also carefully check: local barcodes if any, formula, shelflife if
mentioned, storage conditions and trademarks.

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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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