CIPROFLOXACIN HYDROCHLORIDE 0.3% EYE DROPS SOLUTION

Active substance: CIPROFLOXACIN HYDROCHLORIDE

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Package Leaflet - Information for the User

CILOXAN® 0.3% 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.
The name of your medicine is Ciloxan 0.3% eye drops solution but will be referred to as
Ciloxan throughout this leaflet.
IN THIS LEAFLET
1. What CILOXAN is and what it is used for
2. Before you use CILOXAN
3. How to use CILOXAN

1

WHAT CILOXAN IS AND WHAT IT IS USED FOR

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

2

4. Possible side effects
5. How to store CILOXAN
6. Further information

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

BEFORE YOU USE CILOXAN

Do not use CILOXAN...
• If you are allergic to ciprofloxacin or any
other quinolone antibiotic or to any of the
other ingredients listed in section 6.

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

• In CHILDREN under the age of 1 year.
Ask your doctor for advice.

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, theophylline and caffeine.
You must tell your doctor if you are taking other
medicines that can alter your heart rhythm:
medicines that belong to the group of antiarrythmics (e.g. quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide,
ibutilide), tricyclic antidepressants, some
antimicrobials (that belong to the group of
macrolides), some antisychotics.

Take special care with 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.
Heart problems
Caution should be taken when using this kind of
medicine, if you were born with or have family
history of prolonged QT interval (seen on ECG,
electrical recording of the heart), have salt
imbalance in the blood (especially low level of
potassium or magnesium in the blood), have a very
slow heart rhythm (called ‘bradycardia’), have a
weak heart (heart failure), have a history of heart
attack (myocardial infarction), you are female or
elderly or you are taking other medicnes that result
in abnormal ECG changes (see section Taking
other medicines).
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.

3

Important information if you wear Contact
Lenses
Wearing contact lenses is not advisable
during the treatment of an eye infection, as
they may make your condition worse.
Do not use the drops while contact lenses
are in your eyes. Wait at least 15 minutes after
using the eye drops before putting your lenses
back in. There is a preservative in CILOXAN
(benzalkonium chloride) that can discolour soft
contact lenses.

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.
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.

It is important that you continue to use
CILOXAN for the full treatment period as
advised by your doctor.
You should not use CILOXAN for more than
21 days, unless your doctor says otherwise.
CILOXAN should not be used in CHILDREN
under the age of 1 year.
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.

3

HOW TO USE CILOXAN

How to use

• Wash your hands before you
start.

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

• 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
go in here (picture 1).

• 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.

4

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

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

• 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.

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

• If you use more CILOXAN than you should it
can be washed out of your eye with warm
water.
If you have any further questions on the use of
CILOXAN, ask your doctor or pharmacist.

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):
Burning, discomfort, itching, feeling of something in
the eye, redness of the eye or inside of the eyelid,
crusting on the eyelid, swollen eyelid(s), decreased
vision, watery eyes, sensitivity to light, white
particles in your eyes.
If you notice white particles in your eyes,
continue to use CILOXAN but tell your doctor
immediately.

• You may also experience effects in
other areas of your body including:
Nausea, bad taste in your mouth, allergic
reactions (such as rash, itching, swelling,
breathing difficulties).
Heart problems
Not known: Abnormal fast heart rhythm, lifethreatening irregular heart rhythm, alteration of the
heart rhythm (called ‘prolongation of QT interval’,
seen on ECG, electrical activity of the heart).
If any of the side effects get serious, or
you notice any side effects not listed in this leaflet,
tell your doctor or pharmacist.
If you experience an allergic reaction,
stop using CILOXAN and tell your doctor.

5

HOW TO STORE CILOXAN

• Keep Ciloxan in a safe place out of the sight and
reach of children.
• Store Upright.
• Keep the container tightly closed. Do not store
above 25°C.
• Do not use this medicine after the expiry date
shown as “Exp” on the label and carton.
• This medicine must be discarded one month
after first opening.
• If the eye drops become discoloured or show any
signs of deterioration, you should seek the
advice of your pharmacist
6

• Stop using the bottle 4 weeks 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
• Each ml of solution contains 3.5 mg of
ciprofloxacin hydrochloride (equivalent to 3.0 mg
of ciprofloxacin).
• It also contains 0.06 mg of benzalkonium
chloride in each ml of solution as a preservative.
• Other ingredients include sodium acetate, acetic
acid, mannitol, edetate disodium and purified
water.

• Hydrochloric acid and/or sodium hydroxide may
also be included in very small quantities to
adjust the acidity or alkalinity of the product to
ensure comfort of the product in the eye.
What CILOXAN looks like and contents of the
pack
Ciloxan is supplied as a clear colourless eye drops
sterile solution in a 5 ml drop-tainer LDPE bottle
and plug with a polystyrene cap.

Manufactured by:
Alcon-Portugal. Quinta da Fonte, Edificio D. Sancho
I – Piso 3, R. Malhoes 4, P-2770-071 Paco D’Arcos,
Portugal.

CILOXAN® 0.3% eye drops, solution
PL No: 18799/1683

Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.

Ciloxan is a registered trademark of Alcon
Laboratories (U.K.) Limited

POM

Leaflet date: 03.08.2012

Package Leaflet - Information for the User

CIPROFLOXACIN HYDROCHLORIDE 0.3% eye drops solution
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.
The name of your medicine is Ciprofloxacin Hydrochloride 0.3% eye drops solution but will be referred
to as Ciprofloxacin Hydrochloride throughout this leaflet.
IN THIS LEAFLET
1. What CIPROFLOXACIN HYDROCHLORIDE is
and what it is used for
2. Before you use CIPROFLOXACIN
HYDROCHLORIDE
3. How to use CIPROFLOXACIN
HYDROCHLORIDE

1

WHAT CIPROFLOXACIN HYDROCHLORIDE IS AND WHAT IT IS USED FOR

CIPROFLOXACIN HYDROCHLORIDE belongs to
a group of medicines known as quinolone
antibiotics.

2

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

BEFORE YOU USE CIPROFLOXACIN HYDROCHLORIDE

Do not use CIPROFLOXACIN
HYDROCHLORIDE...
• If you are allergic to ciprofloxacin or any
other quinolone antibiotic or to any of the
other ingredients listed in section 6.
• In CHILDREN under the age of 1 year.
Ask your doctor for advice.
Take special care with Ciprofloxacin
Hydrochloride
As with any antibiotic, use of CIPROFLOXACIN
HYDROCHLORIDE for a long time may lead to
other infections.
If your symptoms get worse or suddenly return
tell your doctor.
Heart problems
Caution should be taken when using this kind of
medicine, if you were born with or have family
history of prolonged QT interval (seen on ECG,
electrical recording of the heart), have salt
imbalance in the blood (especially low level of
potassium or magnesium in the blood), have a very
slow heart rhythm (called ‘bradycardia’), have a
weak heart (heart failure), have a history of heart
attack (myocardial infarction), you are female or
elderly or you are taking other medicnes that result
in abnormal ECG changes (see section Taking
other medicines).
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 CIPROFLOXACIN
HYDROCHLORIDE.

3

4. Possible side effects
5. How to store CIPROFLOXACIN
HYDROCHLORIDE
6. Further information

Driving and using machines
If your sight is affected in any way following use of
CIPROFLOXACIN HYDROCHLORIDE you
should not drive or operate machinery.
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
CIPROFLOXACIN HYDROCHLORIDE, can react
with some other commonly used medicines, such
as those containing warfarin, theophylline and
caffeine.
You must tell your doctor if you are taking other
medicines that can alter your heart rhythm:
medicines that belong to the group of anti
arrythmics (e.g. quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide,
ibutilide), tricyclic antidepressants, some
antimicrobials (that belong to the group of
macrolides), some antisychotics.
Important information if you wear Contact
Lenses
Wearing contact lenses is not advisable during
the treatment of an eye infection, as they may
make your condition worse.
Do not use the drops while contact lenses are
in your eyes. Wait at least 15 minutes after using
the eye drops before putting your lenses back in.
There is a preservative in CIPROFLOXACIN
HYDROCHLORIDE (benzalkonium chloride) that
can discolour soft contact lenses.

HOW TO USE CIPROFLOXACIN HYDROCHLORIDE

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.
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.
It is important that you continue to use
CIPROFLOXACIN HYDROCHLORIDE for the full
treatment period as advised by your doctor.
You should not use CIPROFLOXACIN
HYDROCHLORIDE for more than 21 days, unless
your doctor says otherwise.
CIPROFLOXACIN HYDROCHLORIDE should not
be used in CHILDREN under the age of 1 year.
Remove the loose collar from the cap when the
bottle is first opened.
Always use CIPROFLOXACIN HYDROCHLORIDE
exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not
sure.

3

HOW TO USE CIPROFLOXACIN HYDROCHLORIDE

How to use

• Wash your hands before you
start.

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

• 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
go in here (picture 1).

• If a drop misses your eye, try again.
• If you forget to use CIPROFLOXACIN
HYDROCHLORIDE, do not worry, just use it
when it is next due. Do not take a double dose
to make up.

4

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

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

• 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.

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

• If you use more CIPROFLOXACIN
HYDROCHLORIDE than you should it can be
washed out of your eye with warm water.
If you have any further questions on the use of
CIPROFLOXACIN HYDROCHLORIDE, ask your
doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, CIPROFLOXACIN
HYDROCHLORIDE can cause side effects,
although not everybody gets them.

• You may experience some or all of the
following effects in your eye(s):
Burning, discomfort, itching, feeling of something in
the eye, redness of the eye or inside of the eyelid,
crusting on the eyelid, swollen eyelid(s), decreased
vision, watery eyes, sensitivity to light, white
particles in your eyes.
If you notice white particles in your eyes,
continue to use CIPROFLOXACIN
HYDROCHLORIDE but tell your doctor
immediately.

• You may also experience effects in other
areas of your body including:
Nausea, bad taste in your mouth, allergic
reactions (such as rash, itching, swelling,
breathing difficulties).
Heart problems
Not known: Abnormal fast heart rhythm, lifethreatening irregular heart rhythm, alteration of the
heart rhythm (called ‘prolongation of QT interval’,
seen on ECG, electrical activity of the heart).
If any of the side effects get serious, or you
notice any side effects not listed in this leaflet, tell
your doctor or pharmacist.
If you experience an allergic reaction, stop
using CIPROFLOXACIN HYDROCHLORIDE and
tell your doctor.

5

HOW TO STORE CIPROFLOXACIN HYDROCHLORIDE

• Keep Ciprofloxacin Hydrochloride in a safe place
out of the sight and reach of children.
• Store Upright.
• Keep the container tightly closed. Do not store
above 25°C.
• Do not use this medicine after the expiry date
shown as “Exp” on the label and carton.
• This medicine must be discarded one month
after first opening.
• If the eye drops become discoloured or show any
signs of deterioration, you should seek the
advice of your pharmacist
6

• Stop using the bottle 4 weeks 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 CIPROFLOXACIN HYDROCHLORIDE
contains
• Each ml of solution contains 3.5 mg of
ciprofloxacin hydrochloride (equivalent to 3.0 mg
of ciprofloxacin).
• It also contains 0.06 mg of benzalkonium
chloride in each ml of solution as a preservative.
• Other ingredients include sodium acetate, acetic
acid, mannitol, edetate disodium and purified
water.
Manufactured by:
Alcon-Portugal. Quinta da Fonte, Edificio D. Sancho
I – Piso 3, R. Malhoes 4, P-2770-071 Paco D’Arcos,
Portugal.
Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.

• Hydrochloric acid and/or sodium hydroxide may
also be included in very small quantities to
adjust the acidity or alkalinity of the product to
ensure comfort of the product in the eye.
What CIPROFLOXACIN HYDROCHLORIDE
looks like and contents of the pack
Ciprofloxacin Hydrochloride is supplied as a clear
colourless eye drops sterile solution in a 5 ml
drop-tainer LDPE bottle and plug with a
polystyrene cap.

CIPROFLOXACIN HYDROCHLORIDE
0.3% eye drops, solution
PL No: 18799/1683
Leaflet date: 03.08.2012

POM

Expand view ⇕

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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