Cilodex ear drops

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Dexamethasone; Ciprofloxacin hydrochloride
Available from:
CST Pharma Ltd
ATC code:
S02CA06
INN (International Name):
Dexamethasone; Ciprofloxacin hydrochloride
Dosage:
1mg/1ml ; 3mg/1ml
Pharmaceutical form:
Ear drops
Administration route:
Auricular
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 12010100; GTIN: 5055946807546

PATIENT INFORMATION LEAFLET

Cilodex

®

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

(ciprofloxacin hydrochloride / dexamethasone)

The name of your medicine is Cilodex® 3 mg/ml / 1 mg/ml ear drops,

suspension but will be referred to as Cilodex throughout the

remainder of this leaflet.

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.

What is in 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 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 anti-inflammatory agent that will

help to relieve inflammation and redness.

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).

2. 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.

Contact your doctor if you experience blurred vision or other visual

disturbances.

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.

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.

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.

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.

3. Give drops

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

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.

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.

S0686-5-FR-PIL-03.12.2018

POM

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.

6. Stay on side

The patient should remain on his/her side around 5 minutes to facilitate

penetration of the drops into the ear.

When you raise your head up again, some drops can run out. You can

dry them with a non-sterile absorbent paper.

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.

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.

If you have any further questions on 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.

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.

Common: May affect up to 1 in 10 people

Effects in the ear: ear pain.

Uncommon: May affect up to 1 in 100 people

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.

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

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

residue.

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 eye: blurred vision

Effects in the ear: ear inflammation

General side effects: allergy

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed on this leaflet. You can also report

side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the

Google Play or Apple App Store. By reporting side effects, you can help

provide more information on the safety of this medicine.

5. How to store Cilodex

Keep 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.

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.

If the suspension becomes discoloured or show any signs of

deterioration, you should seek the advice of your pharmacist.

6. Contents of the pack and other information

What Cilodex contains

The active substances are ciprofloxacin and dexamethasone.

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, hydrochloric acid/sodium hydroxide (for pH-

adjustment) and purified water.

What Cilodex looks like and contents of the pack

Cilodex is a white to off-white uniform suspension contained in a 5 ml

bottle (LDPE) with a white cap (PP).

Pack size: 5ml

Manufacturer

S.A. Alcon-Couvreur N.V. Rijksweg 14, B-2870 Puurs, Belgium.

Procured from within the EU and repackaged by:

Amimed Direct

Ltd., Hendon London, NW9 6AQ.

Product Licence Holder:

Sam Pharma Ltd., Unit 20 Garrick Industrial

Estate, Irving Way, Hendon, London, NW9 6AQ.

PL 33902/0686

Leaflet revision date: 03/12/2018

Cilodex

is a registered trade mark of Novartis AG.

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.

Blind or partially sighted? Is this

leaflet hard to see or read? Call

02082033203 to obtain the leaflet in

a format suitable for you.

S0686-5-FR-PIL-03.12.2018

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