CILOXAN 3 Mg/Ml Ear Drops Solution

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

CIPROFLOXACIN HYDROCHLORIDE

Dostępny od:

Alcon Laboratories (UK) Ltd

Kod ATC:

S02AA15

INN (International Nazwa):

CIPROFLOXACIN HYDROCHLORIDE

Dawkowanie:

3 Mg/Ml

Forma farmaceutyczna:

Ear Drops Solution

Typ recepty:

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

Dziedzina terapeutyczna:

Antiinfectives

Status autoryzacji:

Authorised

Data autoryzacji:

2006-02-03

Ulotka dla pacjenta

KAPVORM
140 x 335 / 140 x 22 mm
AANTAL KLEUREN :  
1
HB
31/10/2013
IRL
recto-verso
Ciloxan Ear 5 ml -DRAFT-
45842-5
BELGIUM
V1
PMS ZWART
à 100%
45842-5
DO NOT USE CILOXAN...
• If you are ALLERGIC to ciprofloxacin or any
other quinolones or to any of the other
ingredients listed in section 6.
• Only use CILOXAN in children younger
than 1 year if explicitly prescribed by your
doctor.
TAKE SPECIAL CARE...
• Only use CILOXAN in your ears.
• 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 notice the first signs of a skin rash
or any other allergic reaction, including
hives, itching, breathing problems, stop
treatment and immediately contact your
doctor. If you have a serious allergic
reaction then you may need emergency
treatment.
• If you feel pain, swelling or inflammation
while or shortly after taking this medicine,
stop treatment and contact your doctor.
• If you are elderly or if you are taking
medicines called 'corticosteroids' used to
treat conditions such as pain and
inflammation, asthma or skin problems
then, you have a higher risk of getting
tendon problems during treatment with
CILOXAN. If you experience any
inflammation or an inflammatory condition,
stop treatment and immediately consult
your doctor.
• Avoid  EXCESSIVE SUNLIGHT while using
CILOXAN.
You should TALK TO YOUR DOCTOR before
using CILOXAN if you are not sure.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or might get pregnant,
or if you are breast-feeding a baby, TALK TO
YOUR DOCTOR before you use CILOXAN.
USING OTHER MEDICINES
TELL YOUR DOCTOR OR PHARMACIST if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription. QUINOLONE
ANTIBIOTICS, such as CILOXAN, can react
with some other commonly used medicines,
such as those containing WARFARIN (blood
thinner),  THEOPHYLLINE (used to treat
asthma) and CAFFEINE. It can also react with
me

Charakterystyka produktu

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 a 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 and children 1 year and above:
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., 6 drops
for paediatric patients and 8 drops for adult patients).
Use in elderly
No dosage alteration in elderly patients is necessary. 
In clinical studies conducted with CILOXAN, the probability of having an adverse reaction was independent of age. No
difference in patients experiencing adverse reactions was noted in patients less than 65 years of age,
between 65 and 75
years of age, and greater than 75 years of age.
HEALTH PRODUCTS REGULATORY AUTHORITY
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