CILODEX 3 mg/1 mg Krople Do Uszu, Zawiesina

Treść ulotki

1. CILODEX 3 mg/ml / 1 mg/ml ear drops, suspension
   1. What you need to know before using CILODEX
   2. How to use CILODEX
   3. Wash your hands
   4. Warm and shake the bottle
   5. Administer the drops
   6. Remain lying on your side
   7. Possible side effects
   8. How to store CILODEX
   9. Contents of the pack and other information

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

Ciprofloxacina/desametasone

Read this leaflet carefully before using 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 may 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 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

1. What CILODEX is and what it is used for

CILODEX is a suspension for ear use (in the ear). It contains:
 ciprofloxacin, an antibiotic belonging to the fluoroquinolone group. Ciprofloxacin works by
killing the bacteria that cause infections;
 dexamethasone, a corticosteroid or anti-inflammatory agent that helps to relieve
inflammation and redness.
CILODEX is in the form of ear drops. This medicine is used for the treatment of acute
middle ear infections (otitis media) in patients with otologic drainage catheters (tympanostomy
tubes or “Grommets”) or for the treatment of an outer ear infection (acute otitis externa). It has been
shown to be safe and effective in pediatric patients 6 months of age, or older, for the
treatment of middle ear infections (AOMT) and in patients 1 year of age, or older, for the
treatment of outer ear infections (AOE).

2. What you need to know before using CILODEX

Do not use CILODEX:
 If you are allergicto ciprofloxacin, dexamethasone or any of the other ingredients of this
medicine (listed in section 6).
 If you are allergicto medicines called quinolone antibiotics, as this medicine may
cause the same type of allergic reaction
 if the ear infection is caused by a virusor a fungus
Warnings and precautions
Talk to your doctor or pharmacist before using CILODEX
 This preparation must be applied exclusively to the ear. It is not suitable for use in the eye and
must not be swallowed, injected or inhaled.
 Once you have started treatment, if you notice the first signs of a rash or any other
allergic symptom (e.g. hives (urticaria), sudden swelling of the face, throat or eyelids,
difficulty breathing), you should immediately stop using the medicine and consult
your doctor. Severe allergic reactions may require immediate emergency treatment.
 Tell your doctor if your symptoms do not improve within a week of starting treatment, worsen
or reappear suddenly. As with all antibiotics, additional infections may sometimes occur
caused by organisms that are not sensitive to ciprofloxacin. In case of such infections, appropriate
treatment should be started under the guidance of your doctor.
 If you experience pain, swelling or inflammation of the tendons during or immediately after using this
medicine, stop treatment and contact your doctor. Pay particular attention if you are over
65 years of age or if you are undergoing treatment with corticosteroids.
 Contact your doctor if you experience blurred vision or other visual disturbances.
 Use in children: clinical experience regarding the use of CILODEX for the treatment of middle ear
infections in children under 6 months of age and for the treatment of outer ear infections in children
under 1 year of age is insufficient; therefore, consult your doctor before
administering this medicine to your child, if you fall within the specified age groups.

If any of these situations apply to you, ask your doctor for advice.

Other medicines and CILODEX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
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 operate machines.

This medicine contains benzalkonium chloridewhich is a known irritant capable of causing
local skin reactions.

3. How to use CILODEX

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor.
The recommended dose for adults and childrenis 4 dropsin the ear canal , twice a day– morning and
evening for 7 days. This medicine is intended to be administered only in the ear (otic use).

Remove the protective mobile ringfrom the cap upon first opening of the bottle.
Your doctor will inform you about the duration of treatment with this medicine. To prevent recurrence of the
infection , do not interrupt the treatment prematurely, even if you notice improvements in the condition of your ear(s).
Use this medicine for both ears only if your doctor has instructed you to do so.

Instructions for use
It is preferable that another person administer the drops for you.Children should never be allowed to self-administer the drops.

1. Wash your hands

The person administering CILODEX should wash their hands with water and soap.

2. Warm and shake the bottle

The person administering CILODEX must hold the bottle in their hands for a few minutes in order to
warm its contents (figure 1) to avoid dizziness resulting from the instillation of a
cold solution into the ear canal, then shake the bottle well before use.

3. Administer the drops

The patient must be lying down with the infected ear facing upwards (figure 2).

Place 4 dropsof CILODEX in the infected ear (figure 3). Do not touchyour fingers or the ear or
any other surface with the tip of the bottleas this could contaminate the drops.

After administering the dropsfollow the instructions below relating to the patient's specific ear infection.

• 4. For patients with middle ear infection with otologic drainage catheters (tympanostomy tubes or “Grommets”):while the patient remains lying on their side, the person administering CILODEX must gently press the skin fold at the entrance of the ear canal
  (figure 4) for 5 timeswith a pumping motion. This will allow the drops to travel through the tube
  reaching the eardrum and the middle ear.

somministra CILODEX deve premere delicatamente il lembo di pelle all'ingresso del canale uditivo
(figura 4) per 5 voltecon un movimento di pompaggio. Ciò consentirà alle gocce di attraversare il tubo
arrivando al timpano e all'orecchio medio.

• 5. For patients with i nfection of the eare sternum.While the patient is lying on their side, the person administering CILODEX must gently pull the outer earlobe upwards and downwards (figure 5). This will allow the ear drops to flow into the ear canal.

6. Remain lying on your side

It is recommended that the patient remain lying on their side for approximately 5 minutes in order to facilitate the
penetration of the drops into the ear.
When raising your head again, some drops may leak out. These can be
dried with a non-sterile absorbent wipe.
It is of fundamental importance to follow these instructions in order to achieve good efficacy of the
medicinal product in the ear. Keeping the head in a vertical position or moving the head too
quickly during the instillation of the ear drops may result in partial loss of the
medicinal product as the drops, rather than penetrating deep into the ear canal, would slide
down the face.
Keep the bottle tightly closed when not in use.
Store the bottle until the end of the treatment. Do not store it for future use.
During application of the medicinal product, be careful that the dropper does not come into contact with
the ear or fingers in order to avoid contamination.
Repeat steps 2 to 5 for the other ear, in case both ears have
infections.

If you use more medicine than you should,inform your doctor or pharmacist .
If you forget to use this medicinedo not worry, simply continue with the next dose.

Do not use a double dose to make up for a missed dose.
If you stop taking CILODEX
Do not stop administering the medicine without informing your doctor or pharmacist. If the condition of
your ear does not improveafter 1 week of treatment, see your doctor again.

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

4. Possible side effects

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

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

Common: affects up to 1 in 10 people

Effects on the ear:ear pain.

Uncommon: affects up to 1 in 100 people

Effects on the ear: ear discomfort, blockage of the ear drainage catheter, tingling,
ear congestion, ear itching, fungal infection of the outer ear, ear discharge, ear enlargement.

General side effects:candidiasis, irritability, crying, skin redness, vomiting,
bad taste sensation, fatigue.

Rare undesirable effects: affects up to 1 in 1000 people

Effects on the ear: hearing loss, tinnitus, drug residue.

General side effects: dizziness, headache, ear redness.
The following undesirable effects have been reported with Cilodex ear drops. The frequency cannot be
estimated based on available data:

Effects on the ear:ear inflammation

General side effects: allergy

Effects on the eye:blurred vision.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly (see details below
reported). By reporting side effects you can help provide more information on the
safety of this medicine.
Website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

5. How to store CILODEX

Keep this medicine out of the sight and reach of children.
Do not use this medicineafter the expiry date which is stated on the bottle and the packaging. The expiry date refers to the last day of that month.
Do not freeze.
Keep the bottle in the outer packaging to protect the medicine from light.

Discard the bottle after 4 weeks from first opening.
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. Contents of the pack and other information

What CILODEX contains
The active ingredients are ciprofloxacin and dexamethasone.
Each ml of suspension contains 3 mg of ciprofloxacin as hydrochloride and 1 mg of dexamethasone.
The other components are benzalkonium chloride, hydroxyethylcellulose, sodium acetate trihydrate, acetic acid,
sodium chloride, disodium edetate, thiosulfate, boric acid, hydrochloric acid/sodium hydroxide (for the
pH adjustment), purified water.

Description of CILODEX and contents of the pack
CILODEX is a uniform suspension whose colour ranges from white to off-white; it is supplied in a
pack containing a 5 ml bottle (LPDE) fitted with a white closure (PP).

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

DISTRIBUTOR
Bruno Farmaceutici S.p.A.
Via delle Ande, 15
00144 Rome

Manufacturer responsible for batch release
S.A. Alcon - Couvreur N.V.
Rijksweg 14, B-2870 Puurs
Belgium

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Denmark Cilodex
France Ciloxadex
Italy Cilodex
Germany Cilodex 3 mg/ml / 1 mg/ml Ohrentropfen, Suspension
Spain Ciloxadex
United Kingdom Cilodex

Other sources of information
More detailed information on this medicinal product is available on the website
www.agenziafarmaco.gov.it/it

Advice/health education
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections. If your
doctor has prescribed antibiotics, they are for exactly the current condition. Despite antibiotics, some resistant
bacteria may survive or increase; consequently, some antibiotic treatments may not be effective. Improper
use of antibiotics may increase resistance. It could even help bacteria become resistant and therefore delay
your recovery or decrease antibiotic efficacy if you do not adequately respect:

• dosages,
• dosage schedule,
• duration of treatment.

Consequently, to preserve the efficacy of this drug:

• 1. Use antibiotics only when prescribed.
• 2. Strictly adhere to the prescription.
• 3. Do not reuse an antibiotic without a prescription, even if you want to treat a similar condition.
• 4. Never give your antibiotic to another person; it may not be suitable for their condition.
• 5. At the end of the treatment, return all unused medicines to your pharmacy to ensure they are disposed of correctly.