Ciloxan 3 mg/ml ear drops, solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Ciprofloxacin hydrochloride

Διαθέσιμο από:

Novartis Ireland Limited

Φαρμακολογική κατηγορία (ATC):

S02AA; S02AA15

INN (Διεθνής Όνομα):

Ciprofloxacin hydrochloride

Δοσολογία:

3 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Ear drops, solution

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Antiinfectives; ciprofloxacin

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2006-02-03

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CILOXAN® 3 MG/ML EAR DROPS, SOLUTION
ciprofloxacin
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 Ciloxan is and what it is used for
2.
What you need to know before you use Ciloxan
3.
How to use Ciloxan
4.
Possible side effects
5.
How to store Ciloxan
6.
Contents of the pack and other information
1.
WHAT CILOXAN IS AND WHAT IT IS USED FOR
Ciloxan contains
CIPROFLOXACIN
, a
QUINOLONE ANTIBIOTIC
that is effective against many of the types of
germs that cause bacterial infection in your ear(s).
It is used to treat acute infections of the outer ear (otitis externa
or “swimmer’s ear”) in adults and
children aged 1 year and above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CILOXAN
DO NOT USE CILOXAN
-
If you are
ALLERGIC
to ciprofloxacin or any other quinolones or to any of the other
ingredients
of this medicine (listed in Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Ciloxan.
-
Only use CILOXAN in your ears.
-
If you notice the first signs of a skin rash or any other allergic
reaction, including hives,
itching or breathing problems, stop treatment and immediately contact
your doctor. If you
have a serious allergic reaction then you may need emergency
treatment.
-
Avoid EXCESSIVE SUNLIGHT
while using Ciloxan.
-
As with any antibiotic, use of Ciloxan for a long time may lead to
other infections. If your
symptoms get worse or suddenly return, tell your doctor.
-
If you feel pain, swelling or inflammation of the tendons

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
22 August 2022
CRN00D481
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciloxan 3 mg/ml ear drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 3mg ciprofloxacin as ciprofloxacin hydrochloride.
Excipient(s) with known effect: one ml of solution contains 0.06mg
benzalkonium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ear drops, solution.
Clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults and Children 1 year and above
Ciloxan is indicated for acute otitis externa due to susceptible
strains of bacterial species shown to be responsive to
ciprofloxacin as listed in section 5.1.
Use should be under the supervision of a specialist ENT service having
the facilities for regular monitoring of clinical and
microbiological effects during and after administration.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
The dose is 4 drops of Ciloxan in the ear canal twice daily for
adults.
For patients requiring use of an otowick, the dose can be doubled for
the first administration only (i.e., 8 drops for adult
patients).
Use in elderly
No dosage alteration in patients 65 years of age or above is
necessary.
Paediatric population
The dose is 3 drops of Ciloxan in the ear canal twice daily for
children 1 year of age and older. For patients requiring use of an
otowick, the dose can be doubled for the first administration only
(i.e., 6 drops for paediatric patients).
The safety and efficacy in paediatric patients below 1 year of age
have not been established.
Use in hepatic and renal impairment
Ciloxan has not been studied in patients with hepatic or renal
impairment and is therefore not recommended in such patients.
Method of administration
For otic use only.
AFTER CAP IS REMOVED, IF TAMPER EVIDENT SNAP COLLAR IS LOOSE, REMOVE
BEFORE USING PRODUCT.
The user s