Ciproxin HC Otic Ear Drops Suspension 2mg/10mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CIPROFLOXACIN, HYDROCORTISONE

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

S02CA03

INN (International Name):

CIPROFLOXACIN 2 mg/ml HYDROCORTISONE 10 mg/ml

Pharmaceutical form:

EAR DROPS, SUSPENSION

Composition:

CIPROFLOXACIN 2 mg/ml HYDROCORTISONE 10 mg/ml

Prescription type:

POM

Therapeutic area:

OTOLOGICALS

Authorization status:

Authorised

Authorization date:

2005-09-27

Patient Information leaflet

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPROXIN HC OTIC*, 2MG/ML AND 10MG/ML, EAR DROPS SUSPENSION
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE
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. See section 4.
WHAT IS IN THIS LEAFLET
1. What Ciproxin HC Otic* is and what is it used for
2. What you need to know before you use Ciproxin HC Otic*
3. How to use Ciproxin HC Otic*
4. Possible side effects
5. How to store Ciproxin HC Otic*
6. Contents of the pack and other information
1. WHAT CIPROXIN HC OTIC* IS AND WHAT IS IT USED FOR
Ciproxin HC Otic*
ear drops suspension contains two active ingredients, a steroidal
anti-inflammatory
and an antibacterial antibiotic.
Ciproxin HC Otic*
ear drops suspension is a white to off-white liquid, supplied as ear
drops in 10 ml
glass bottles.
This medication is used to treat acute otitis externa in cases where
the ear drum is not perforated, in
adults and children older than 2 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CIPROXIN HC OTIC*
Before prescribing this medication, your doctor should have examined
your ears to ensure that your ear
drums are not perforated.
Do not use Ciproxin HC Otic*
ear drops suspension:
−
If you are allergic to ciprofloxacin or any other medication of the
quinolone group.
−
If you are allergic to hydrocortisone or any other component of
Ciproxin HC Otic*
ear drops
suspension.
−
If your ear drum is perforated or damaged.
−
If you suffer from viral infections of the ear, including varicella
virus or herpes simplex virus
infections.
−
If you think

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CIPROXIN* HC OTIC, ear drops, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml ear drop suspension contains 2.329 mg ciprofloxacin hydrochloride
monohydrate equivalent
(equivalent to 2 mg ciprofloxacin) and 10mg hydrocortisone.
Excipients with known effect:
This medicine contains 90 mg Benzyl alcohol in each 10 ml which is
equivalent to 9 mg/ml.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, suspension.
The suspension is opaque and white to off-white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute bacterial otitis externa, in the absence of
perforated tympanic membrane. Consideration
should be given to official guidance on the appropriate use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For otic use only.
Posology:
In adults and in children over two years old: instill 3 drops of
suspension into the affected ear, twice a day.
Duration of treatment: 7 days.
Method of administration:
Ear drop instillation.
Warm the bottle just before use by holding it in the palm of your hand
for a few minutes. This will prevent
any unpleasant sensation associated with the cold suspension coming
into contact with the ear. Shake well
before use.
With the head tilted, instill the drops into the affected ear. Keep
the head tilted on its side for at least 30
seconds to enable the drops to penetrate into the external auditory
canal. Repeat, if necessary, in the other
ear.
Shake before use. Just before use, remove the cap from the bottle and
replace it with the measured dropper.
CIPROXIN* is ready to use as soon as the dropper is in place. At the
end of the course of treatment, the
remainder of the bottle should be discarded and should not be kept for
reuse.
4.3
CONTRA-INDICATIONS
Page 2 of 8
This product SHOULD NEVER BE USED in patients with:
-
hypersensitivity to ciprofloxacin or other quinolones
-
hypersensitivity to hydrocortisone or any other ingredient in the
suspension
-
known or suspe