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CILOXAN 0.3% W/V EYE DROPS

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35459-8

Package Leaflet - Information for the User

CILOXAN® 0.3  % w  /v eye drops, solution
Ciprofloxacin ( as hydrochloride )
Read all of this leaflet carefully before you start using this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET
1. What CILOXAN is and what it is used for
2. Before you use CILOXAN

4. Possible side effects
5. How to store CILOXAN

3. How to use CILOXAN

6. Further information

1

WHAT CILOXAN® IS AND WHAT IT IS USED FOR

CILOXAN belongs to a group of medicines
known as quinolone antibiotics.

2

BEFORE YOU USE CILOXAN®

Do not use CILOXAN ...
• If you are allergic (hypersensitive) to
ciprofloxacin or any other quinolone
antibiotic or to any of the other ingredients
listed in section 6.
Ask your doctor for advice.

Take special care ...
• Only use CILOXAN in your eyes.
• Only use CILOXAN in children younger than
1 year if prescribed by your doctor.
• 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. You may become
more susceptible to other infections with the
use of this medicine, especially after
prolonged use.
• 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

3

It is used for the treatment of corneal ulcers
and some other bacterial infections of the
eye(s).

you experience any inflammation or
inflammatory condition, stop treatment and
immediately consult your doctor.

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.

Driving and using machines
If your sight is temporarily blurred or affected
in any way following use of CILOXAN you
should not drive or operate machinery until
your vision is clear again.

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.
If you are using more than one type of eye
medicine, the medicines must be used at least
5 minutes apart. Eye ointments should be used
last.

Important information if you wear
Contact Lenses
There is a preservative in CILOXAN
(benzalkonium chloride) that may cause eye
irritation and can discolour soft contact lenses.
Do not wear contact lenses (hard or soft)
during treatment with CILOXAN. If you do
continue to wear your lenses, you must
remove them before using CILOXAN and wait
at least 15 minutes after use before putting
your lenses back in.

HOW TO USE CILOXAN®

The usual dose

This will depend on whether you are being
treated for corneal ulcers or for some other
bacterial infection in your eye.

Corneal Ulcers

Dosing is continued during the night time.
Day 1 - 2 drops every 15 minutes for the first 6
hours and then 2 drops every 30 minutes.
Day 2 - 2 drops every hour.
Day 3 to Day 14 - 2 drops every 4 hours.
Your doctor will tell you if treatment needs to
be continued for longer than 14 days.

It is important that you continue to use
CILOXAN for the full treatment period as
advised by your doctor even if your symptoms
improve. If you stop using this medicine too
early, your symptoms may re-occur.
You should not use CILOXAN for more than
21 days, unless your doctor says otherwise.
Remove the loose collar from the cap when
the bottle is first opened.
Always use CILOXAN exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.

Other bacterial infections

1 or 2 drops 4 times a day. For severe
infections the dose for the first 2 days may be
increased to 1 or 2 drops every 2 hours, while
you are awake.

Continued over

354598_GB_p2_LFT.indd 1

07/03/2017 10:20

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

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Live Text:
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Comp. Description: Leaflet_CILOXAN_LDMO_0.3% 5ML_GB
Comp. Number New: 354598 GB
Comp. Number Old: 354597 GB
Format/Dimension: 140x335_140x22 mm
Tech. Drawing No.: TECH_INS_140x335_140x22_001

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Production Site:
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Printing Colours:

Alcon Puurs
Martin, Rosalyn
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Minimum Font Size: 6.0pt
Font Type: Helvetica Neue LT Pro
Proof Number: 2
Braille:

07/03/2017

Rachel Smith

! P LE ASE TU R N OVE R P R I N T I N G O N !
5093513_1

3

HOW TO USE CILOXAN® (continued)

How to use

• Bring the bottle tip close to the eye.
Do this in front of a mirror if it helps.

• Wash your hands before you
start.

• Do not touch your eye or eyelid,
surrounding areas or other surfaces with the
dropper. It could infect the drops.

• Twist off the bottle cap.
• Hold the bottle pointing
down, between your thumb
and fingers.

• Gently press on the base of the bottle to
release one drop at a time ( picture 2 ).
• Do not squeeze the bottle, only a gentle
press on the bottom is needed.

• Tilt your head back.
• Pull down your lower eyelid
with a finger, until there is a
‘pocket’ between the eyelid
and your eye. The drop will
1
go in here ( picture 1 ).

• If you use drops in both eyes, repeat the
steps for your other eye. Put the bottle cap
firmly back on immediately after use.

3

2

• If a drop misses your eye, try again.
• If you forget to use CILOXAN, do not worry,
just use it when it is next due. Do
not take a double dose to make up.
• If you use more CILOXAN than you should
it can be washed out of your eye with
lukewarm water.

4

POSSIBLE SIDE EFFECTS

Like all medicines, CILOXAN can cause side
effects, although not everybody gets them.
• You may experience some or all of the
following effects in your eye(s):
Common (1 to 10 users in 100): White
deposits on the eye surface (cornea),
discomfort (stinging or burning, gritty feeling in
the eye, irritation), redness.
Uncommon (1 to 10 users in 1,000): Damage
to the eye surface (cornea), sensitivity to light,
blurred vision, swelling of the eye or eyelid,
pain, dry eye, itchiness, eye discharge, eyelid
crusting, eyelids scales, eyelid redness, poor
vision, watery eyes, red eyes
Rare (1 to 10 users in 10,000): Damage of the
eye, inflammation, double vision, decreased
eye sensation, tired eyes, stye.
If you notice white particles in your eyes,
continue to use CILOXAN but tell your doctor
immediately.

5






• You may also experience effects in other
areas of your body including:
Common: Bad taste.
Uncommon: Headache, nausea.
Rare: Hypersensitivity, dizziness, ear pain,
inflammation inside the nose, nasal sinus
discharge, diarrhoea, abdominal pain, skin
inflammation, tendon disorder.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
If you experience an allergic reaction, stop
using CILOXAN and tell your doctor.

HOW TO STORE CILOXAN®

Keep out of the reach and sight of children.
Do not store above 25°C.
Do not refrigerate or freeze.
Keep the bottle tightly closed.
Do not use the drops after the expiry date
(marked ‘Exp’) on the bottle and the carton.
The expiry date refers to the last day of that
month.

6

• If this medicine is accidentally swallowed, it
is not likely to cause any serious problems,
but contact your doctor.
If you have any further questions on the use
of CILOXAN, ask your doctor or pharmacist.

• Stop using the bottle 28 days after first
opening, to prevent infections.
• Medicines should not be disposed of via
waste water or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
• Do not pass this medicine on to others. It
may harm them, even if their symptoms are
the same as yours

FURTHER INFORMATION

What CILOXAN contains
• The active substance is ciprofloxacin 3 mg/ml
(as the hydrochloride).
• The other ingredients are sodium acetate,
acetic acid, mannitol, edetate disodium,
benzalkonium chloride, hydrochloric acid
and/or sodium hydroxide (to adjust pH) and
purified water.

Marketing authorisation holder:

Novartis Pharmaceuticals UK Limited
Frimley Business Park,
Frimley, Camberley,
Surrey, GU16 7SR
United Kingdom.

What CILOXAN looks like and
contents of the pack
CILOXAN is a clear, colourless liquid supplied
in a pack containing a 5 ml plastic bottle with
a screw cap.

Manufacturer  :

SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.
This leaflet was last revised in 02/2017
®

© 2005, 2011, 2013 Novartis
35459-8

02-2017

354598_GB_p2_LFT.indd 2

07/03/2017 10:20

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
WO:
1585791
Comp. Description: Leaflet_CILOXAN_LDMO_0.3% 5ML_GB
Comp. Number New: 354598 GB
Comp. Number Old: 354597 GB
Format/Dimension: 140x335_140x22 mm
Tech. Drawing No.: TECH_INS_140x335_140x22_001

Both

Production Site:
CTM:
Printing Colours:

Alcon Puurs
Martin, Rosalyn
Black

Technical Colours: Cutting

Minimum Font Size: 6.0pt
Font Type: Helvetica Neue LT Pro
Proof Number: 2
Braille:

07/03/2017

Rachel Smith

! P LE ASE TU R N OVE R P R I N T I N G O N !
5093513_1

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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