CIPROFLOXACIN 0.3% EYE DROPS

Active substance: CIPROFLOXACIN HYDROCHLORIDE

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S0593 LEAFLET Ciloxan 20140415

PACKAGE LEAFLET: INFORMATION FOR THE USER
CILOXAN EYE DROPS
(ciprofloxacin hydrochloride)

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.

Your medicine is known as Ciloxan Eye Drops but will be referred to
as Ciloxan throughout the following leaflet.

Important information if you wear Contact Lenses

Read all of this leaflet carefully before you start using this
medicine.

Do not wear contact lenses (hard or soft) during treatment with
Ciloxan.



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.

There is a preservative in Ciloxan (benzalkonium chloride) that may
cause eye irritation and can discolour soft contact lenses.

3. 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.

IN THIS LEAFLET:

Day 2 - 2 drops every hour.

1. What Ciloxan is and what it is used for

Day 3 to Day 14 - 2 drops every 4 hours.

2. Before you use Ciloxan

Your doctor will tell you if treatment needs to be continued for
longer than 14 days.

3. How to use Ciloxan
4. Possible side effects
5. How to store 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.
It is used for the treatment of corneal ulcers and some other
bacterial infections of the eye(s).
2. BEFORE YOU USE CILOXAN

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 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.

Do not use Ciloxan...

Always use Ciloxan exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.



How to use

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...



Wash your hands before you start.



Twist off the bottle cap.



Hold the bottle pointing down, between your
thumb and fingers.



Only use Ciloxan in your eyes.



Tilt your head back.



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.

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)



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 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.



If this medicine is accidentally swallowed, it is not likely to
cause any serious problems, but contact 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 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 breastfeeding 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.

If you have any further questions on the use of Ciloxan, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

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

What Ciloxan contains





It contains 0.3%w/v of the active ingredient, ciprofloxacin (as
the hydrochloride). It also contains 0.006%w/v of benzalkonium
chloride as a preservative.



Ciloxan Eye Drops also contain the following inactive
ingredients: disodium edetate, mannitol, acetic acid, sodium
acetate 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.

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 or staining of the
eye surface (cornea), sensitivity to light, blurred vision, swelling of
the eye or eyelid, pain, dry eye, itchiness, abnormal sensation, eye
discharge, eyelid crusting, eyelids scales, eyelid redness, poor
vision, watery eyes, red eyes

What Ciloxan looks like and contents of the pack

Rare (1 to 10 users in 10,000): Damage of the eye, inflammation,
disorder of the eye surface (cornea), double vision, decreased eye
sensation, tired eyes
If you notice white particles in your eyes, continue to use Ciloxan
but tell your doctor immediately.

It is a sterile, colourless solution.



Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer

You may also experience effects in other areas of your
body including:

Common: Bad taste.
Uncommon: Headache, nausea.
Rare: Hypersensitivity, dizziness, ear pain, stye, inflammation inside
the nose, nasal sinus discharge, diarrhoea, abdominal pain, skin
inflammation, drug intolerance, abnormal laboratory tests.
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.
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.
5. HOW TO STORE CILOXAN


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Store in the outer carton in order to
protect from light.



Do not refrigerate or freeze. Store upright.



Discard 28 days after first opening.



Do not use after the expiry date printed on the carton or bottle
label.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Ciloxan Eye Drops are available in bottle containing 5ml of solution.
Product Licence holder

This product is manufactured by Alcon-Couvreur NV, Puurs,
Belgium.
POM

PL No: 19488/0593

Leaflet revision date: 15 April 2014
Ciloxan is a registered trademark of Alcon Inc., Switzerland.
S0593 LEAFLET Ciloxan 20140415

S0593 LEAFLET Ciprofloxacin 20140404

PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPROFLOXACIN 0.3% EYE DROPS
(ciprofloxacin hydrochloride)

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.

Your medicine is known as Ciprofloxacin 0.3% Eye Drops but will
be referred to as Ciprofloxacin throughout the following leaflet.

Important information if you wear Contact Lenses

Read all of this leaflet carefully before you start using this
medicine.

Do not wear contact lenses (hard or soft) during treatment with
Ciprofloxacin.



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.

There is a preservative in Ciprofloxacin (benzalkonium chloride) that
may cause eye irritation and can discolour soft contact lenses.

3. HOW TO USE CIPROFLOXACIN
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.

IN THIS LEAFLET:

Day 2 - 2 drops every hour.

1. What Ciprofloxacin is and what it is used for

Day 3 to Day 14 - 2 drops every 4 hours.

2. Before you use Ciprofloxacin

Your doctor will tell you if treatment needs to be continued for
longer than 14 days.

3. How to use Ciprofloxacin
4. Possible side effects
5. How to store Ciprofloxacin
6. Further information
1. WHAT CIPROFLOXACIN IS AND WHAT IT IS USED FOR
Ciprofloxacin belongs to a group of medicines known as
quinolone antibiotics.
It is used for the treatment of corneal ulcers and some other
bacterial infections of the eye(s).
2. BEFORE YOU USE CIPROFLOXACIN

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 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 Ciprofloxacin for more than 21 days, unless
your doctor says otherwise.
Remove the loose collar from the cap when the bottle is first
opened.

Do not use Ciprofloxacin...

Always use Ciprofloxacin exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.



How to use

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...



Wash your hands before you start.



Twist off the bottle cap.



Hold the bottle pointing down, between your
thumb and fingers.



Only use Ciprofloxacin in your eyes.



Tilt your head back.



Only use Ciprofloxacin in children younger than 1 year if
prescribed by your doctor.





As with any antibiotic, use of Ciprofloxacin 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.

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)



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 a drop misses your eye, try again.



If you forget to use Ciprofloxacin, do not worry, just use it
when it is next due. Do not take a double dose to make up.



If you use more Ciprofloxacin than you should it can be
washed out of your eye with lukewarm water.



If this medicine is accidentally swallowed, it is not likely to
cause any serious problems, but contact 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
Ciprofloxacin. If 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 breastfeeding a baby, talk to your doctor before you use Ciprofloxacin.
Driving and using machines
If your sight is temporarily blurred or affected in any way following
use of Ciprofloxacin you should not drive or operate machinery
until your vision is clear again.

If you have any further questions on the use of Ciprofloxacin, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

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

What Ciprofloxacin contains





It contains 0.3%w/v of the active ingredient, ciprofloxacin (as
the hydrochloride). It also contains 0.006%w/v of benzalkonium
chloride as a preservative.



Ciprofloxacin Eye Drops also contain the following inactive
ingredients: disodium edetate, mannitol, acetic acid, sodium
acetate 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.

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 or staining of the
eye surface (cornea), sensitivity to light, blurred vision, swelling of
the eye or eyelid, pain, dry eye, itchiness, abnormal sensation, eye
discharge, eyelid crusting, eyelids scales, eyelid redness, poor
vision, watery eyes, red eyes

What Ciprofloxacin looks like and contents of the pack

Rare (1 to 10 users in 10,000): Damage of the eye, inflammation,
disorder of the eye surface (cornea), double vision, decreased eye
sensation, tired eyes
If you notice white particles in your eyes, continue to use
Ciprofloxacin but tell your doctor immediately.

It is a sterile, colourless solution.



Product Licence holder

You may also experience effects in other areas of your
body including:

Common: Bad taste.
Uncommon: Headache, nausea.
Rare: Hypersensitivity, dizziness, ear pain, stye, inflammation inside
the nose, nasal sinus discharge, diarrhoea, abdominal pain, skin
inflammation, drug intolerance, abnormal laboratory tests.
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
and tell your doctor.
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.
5. HOW TO STORE CIPROFLOXACIN


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Store in the outer carton in order to
protect from light.



Do not refrigerate or freeze. Store upright.



Discard 28 days after first opening..



Do not use after the expiry date printed on the carton or bottle
label.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Ciprofloxacin Eye Drops are available in bottle containing 5ml of
solution.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by Alcon-Couvreur NV, Puurs,
Belgium.
POM

PL No: 19488/0593

Leaflet revision date: 15 April 2014
S0593 LEAFLET Ciprofloxacin 20140415

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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