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CIPROFLOXACIN 0.3% W/V EYE DROPS SOLUTION

Active substance(s): CIPROFLOXACIN

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Ciloxan Eye Drops, Solution/
Ciprofloxacin 0.3% w/v Eye Drops, Solution
(ciprofloxacin hydrochloride)
Your medicine is known by any of the above names, but will be referred to
as Ciloxan throughout this:
Patient Information Leaflet

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.

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.

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.

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

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

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.

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.
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 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.
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).

 You may also experience effects in other areas of your body
including:
Common: Bad taste.
Uncommon: Headache, nausea.

 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.

Rare: Hypersensitivity, dizziness, ear pain, stye, inflammation inside the
nose, nasal sinus discharge, diarrhoea, abdominal pain, skin inflammation,
drug intolerance, abnormal laboratory tests.

 Gently press on the base of the bottle to release one drop at a time
(picture 2).

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

 Do not squeeze the bottle, only a gentle press on the bottom is needed.

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

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

5) How to store Ciloxan

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

 Keep all medicines out of the sight and reach of children.
 Make sure the container is properly closed.
 Do not store above 250C. Keep container in the outer carton. Protect from
light.
 Do not use the medicine after it has been open for 4 weeks 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
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 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.
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.

What Ciloxan contains:
Each ml of solution contains 3% w/v 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 clear and colourless to pale yellow eye drops,
sterile solution in a 5ml LDPE bottle with a polypropylene cap.
PL 10383/1902

Ciloxan Eye Drops, Solution/
Ciprofloxacin 0.3% w/v Eye Drops, Solution

POM

Who makes and repackages your medicine?
Your medicine is manufactured Alcon Couvreur N.V., 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: 14.05.2013

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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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