64362-1

III III

Package Leaflet - Information for the User

CILOXAN® 3 mg/g eye ointment

Ciprofloxacin

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 gets 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

CILOXAN is one of a group of medicines called CILOXAN is used to treat infections on the quinolone antibiotics. It works by killing the outside of the eye. germs which have caused the infection in the eye.

Do not use CILOXAN...

•    If you are allergic (hypersensitive) to ciprofloxacin, other quinolone antibiotics or

any of the other ingredients listed in section 6.

•    In CHILDREN under 1 year of age unless explicitly prescribed by your doctor.

Ask your doctor for advice.

Take special care...

•    Only use CILOXAN in your eyes.

•    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 your symptoms get worse or suddenly return, consult your doctor. You may become more susceptible to other infections with the use of this medicine, especially after prolonged use.

•    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.

•    If you feel pain, swelling or inflammation of the tendons while or shortly after taking this medicine, stop treatment and contact 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.

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

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

You may experience blurred vision after using CILOXAN. Do not drive or use any machines unless your vision is clear.

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 eye drops as well as eye ointments, you should use the drops first. Leave a gap of at least five minutes between using the drops and using the ointment.

The usual dose

Corneal Ulcer: Apply ointment every 1-2 hours around the clock for 2 days, then every 4 hours for a further 12 days.

Bacterial Conjunctivitis and Blepharitis: Apply ointment 3 times per day for 2 days, then twice per day for 5 additional 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.

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

Continued over ►

How to use

•    Wash your hands before you start.

•    Remove the cap from the tube.

•    Tilt your head back.

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

•    Bring the ointment tube 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 tip of the tube. It could infect the ointment.

Gently squeeze a small ribbon of ointment (about 1.25 cm long) into the pocket formed between your lower eyelid and your eye (picture 2).

Release the lower eyelid and blink a few times.

If you use ointment in both eyes, repeat the steps for your other eye. Replace and tightly close the cap on the tube.

•    If you forget to use CILOXAN, do not worry. Apply the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular routine. Do not use a double dose to make up.

•    If you use more CILOXAN than you should

rinse it all out 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.

~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 (affects 1 to 10 people in 100): Discomfort (stinging or burning, gritty feeling in the eye, irritation), white deposits on eye surface (cornea), redness.

Uncommon (affects 1 to 10 people in 1000): Damage to the eye surface (cornea), blurred vision, swelling of the eye or eyelid, itching, dry eye, discharge, eyelid crusting, eyelid scales, eyelid redness, red eyes, poor vision, pain, watery eyes, sensitivity to light.

Rare (affects 1 to 10 people in 10000):

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.

• 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.

•    Keep out of the reach and sight of children.

•    Do not store above 25°C.

•    Keep the tube tightly closed.

•    Do not use the ointment after the expiry date (marked ‘Exp’) on the tube and the carton. The expiry date refers to the last day of that month.

•    Stop using the tube 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.

What CILOXAN contains

•    The active substance is ciprofloxacin hydrochloride, equivalent to 3 mg/g of ciprofloxacin.

•    The other ingredients are liquid paraffin, white soft paraffin.

What CILOXAN looks like and contents of the pack

CILOXAN is a white to off-white ointment supplied in a pack containing a 3.5 g metal tube with a screw cap.

Manufacturer:

SA Alcon-Couvreur NV

Rijksweg 14, B-2870 Puurs, Belgium.

This leaflet was last revised in October 2013