Cilodex ear drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone; Ciprofloxacin hydrochloride

Available from:

Consilient Health 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: 5015664000001

Patient Information leaflet

Package Leaflet: Information for the User
CILODEX
® 3 MG/ML / 1 MG/ML EAR DROPS, SUSPENSION
(CIPROFLOXACIN HYDROCHLORIDE / 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.

Your medicine is called CILODEX
®
3 mg/ml / 1 mg/ml ear drops,
suspension but will be referred to as Cilodex throughout 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

Summary of Product characteristics

OBJECT 1
CILODEX 3 MG/ML / 1 MG/ML EAR DROPS,
SUSPENSION
Summary of Product Characteristics Updated 08-Sep-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
CILODEX 3 mg/ml / 1 mg/ml ear drops, suspension
2. Qualitative and quantitative composition
1 ml of suspension contains 3 mg ciprofloxacin (as hydrochloride) and
1 mg dexamethasone.
Excipients with known effect:
1 ml of suspension contains 0.10 mg benzalkonium chloride.
For the full list of excipients, see Section 6.1
3. Pharmaceutical form
Ear drops, suspension.
White to off-white uniform suspension (pH 4.3-4.8).
4. Clinical particulars
4.1 Therapeutic indications
CILODEX is indicated for the treatment of the following infections in
adults and children (see section
4.2). See section 5.1 for commonly susceptible species.
• Acute otitis media in patients with tympanostomy tubes (AOMT)
• Acute otitis externa (AOE)
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
Adults and elderly population
Instil four drops in the affected ear(s) twice a day for 7 days
according to the different instillation
instructions for patients with acute otitis media with typanostomy
tubes and patients with acute otitis
externa.
No overall differences in safety and effectiveness have been observed
between elderly and other adult
patients.
Paediatric population
This medicine has been shown to be safe and effective in paediatric
patients 6 months of age and older for
the treatment of AOMT and 1 year of age and older for the treatment of
AOE (see Section 4.4 for use in
children younger than 6 months for AOMT and in children younger than 1
year for AOE). Cilodex can be
used at the same dose as in adults (see Section 5.2).
Patients with hepatic and renal impairment
Hepatic or renal impairment (mild to moderate) does not alter the
pharmacokinetics of ciprofloxacin or
dexamethasone following systemic administration.
Following topical otic administration of Cilodex ear