CIPROFLOXACIN 0.3% EYE DROPS

Active substance: CIPROFLOXACIN HYDROCHLORIDE

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Ciloxan Eye Drops/
Ciprofloxacin 0.3% w/v Eye Drops
(ciprofloxacin hydrochloride)
Your medicine is known by any of the above names, but will be referred to
as Ciloxan throughout this:
Patient Information Leaflet
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 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
3) How to use Ciloxan
4) Possible side effects
5) How to store Ciloxan
6) Further information

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 anti-arrhythmics
(e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol,
dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that
belong to the group of macrolides), some antipsychotics.
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.

1) What Ciloxan is and what it is used for

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.

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

3) How to use Ciloxan

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

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

2) 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.
 In CHILDREN under the age of 1 year.
Ask your doctor for advice.
Take special care...
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 medicines 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.
Driving and using machines
If your sight is affected in any way following use of Ciloxan you should not
drive or operate machinery.

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.

How to use
 Wash your hands before you start
 Twist off the bottle cap

Heart problems
Not known: Abnormal fast heart rhythm, life-threatening irregular heart
rhythm, alteration of the heart rhythm (called ‘prolongation of QT interval’,
seen on ECG, electrical activity of the heart)

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

If any of the side effects get serious, or you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.

 Tilt your head back.

If you experience an allergic reaction, stop using Ciloxan and tell your
doctor.

 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).

5) How to store Ciloxan

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

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






Keep all medicines out of the reach and sight of children.
Make sure the container is properly closed.
Store upright. Do not store above 250C.
Do not use the medicine after it has been open for 28 days or if your eye
drops are past the expiry date which is clearly marked on the box.
 If you have any drops left when your doctor tells you to stop using them,
return them to your pharmacist.
 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.
 Remember, this medicine is for you. Do not share it with anyone else. It
may not suit them.

6) Further information
What Ciloxan contains:
Ciloxan Eye Drops contain the active ingredient ciprofloxacin hydrochloride
which is a fluoroquinolone (quinolone for short).
Each ml of solution contains 3mg of ciprofloxacin (as the hydrochloride).
Ciloxan Eye Drops also includes the following ingredients:
benzalkonium chloride (preservative), sodium acetate, glacial 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 in the eye.
What Ciloxan looks like and contents of the pack
Ciloxan Eye Drops contain 5mls bottle of eye drops, sterile solution, and are
ONLY for use in the eyes.
PL 10383/1499 Ciloxan Eye Drops/Ciprofloxacin 0.3% Eye Drops POM

 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).

Who makes and repackages your medicine?
Your medicine is manufactured S.A Alcon Couvreur N.V, Rijksweg 14, B2870 Puurs, Belgium. Procured from within the EU and repackaged by
Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 18.01.2012

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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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