Ciloxan 0.3%W/V Eye Drops

Document: leaflet MAH BRAND_PL 00649-0125 change

35JS9-7 III!

I I I

Packago Loatlot - Information tor tho Ueor

CILOXAN’ 0.3% w/v eye drops, solution Ciprofloxacin (as hydrochloride)

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

• Koop this loatlot. You may nood to road it again.

• If you havo any further questions, 03k your doctor or your pharmacist

• TNs modicino has boon prescribed for you. Do not pass It on to othors. It may harm them, ovon it tnar symptoms aro tho samo as yours.

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

IN THIS LEAFLET

4. Posoiblo sido offocto

5. How to store CILOXAN

8. Further information

1. What CILOXAN is and what It la used for

2. Before you us© CILOXAN 0. How to uso CILOXAN

H WHAT CILOXAN^ IS AND WHAT IT IS USED FOR B

CILOXAN bokxvgs to a group of modtcince It Is ueod for tho troatmont of cornoal ufccrs known aa qulnolono antibiotics. and some otter bacterial infections of the

eye(a).

gl BEFORE YOU USE CILOXAN⁸

Do not use CILOXAN...

• If you are allergic (hypersensitive) to ciprofloxacin or any ether quinolone antibiotic or to any of the other ingredients listed in section 6.

Ask yotx doctor for advioe.

Take special care...

• Only use CILOXAN in your eyes.

• Only ueo CILOXAN in children youngor than 1 yoar if proscribed by your doctor.

• As with any antfoiotic. use of CILOXAN for a long time may lead to other infections. If your symptoms got worse or suddenly return tell your doctor. You may become more susccptfclo to other infections with tha use at this medicine, especially alter prolonged ueo.

• If you notice the first signs of a skin rash or any other allergic reaction, including hives, itching, brealhing problems stop treatment and immediately contact your doctor It you have a sonous allergic reaction then you may nood omcrgoncy treatment

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

• It you aro oldorty or It you aro taking modcince callod 'corttcoetoroide' usod to treat conditions auch as pain and inflammation, asthma or 8kin prodema then you have a higher risk of getting tendon problems during treatment with CILOXAN. If you ewperitneo any inflammation or inflammatoy condition, step treatment and immediately consvit your doctor

Pregnancy and breast-feeding

If you ore pregnant or might get pregnant or if you are breast-feedng a baby, talk to your doctor before you use CILOXAN.

Driving and using machines If yxxx sight b temporarily blurred cr affected in any way fallowing U3e of CILOXAN you should not drive or operate machinery until your vision b clear again.

Using other medicines Toll your doctor or pharmacist if you aro taking cr have recently taken any other medicines, including medicines obtained without a prescription.

If you ore using more than one type cf eye medicine, the medicines must be used at least 5 minutes apart. Eye ointments should be used last.

Important information if you woar Contact Lenses

There is a preservative in CILOXAN (benzalkoniun chloridel that may cause eye irritation and can discolour soft contact lenses. Do not wear contact lenses (hard or soft) during troatmont with CILOXAN. If you do continue to waar ycur lonsas. you must remove trom before using CILOXAN and wait at least 15 rnnutea alter use before putting your lenses tack in.

HOW TO USE CILOXAN*

Th© usual dos©

This will dopond on wtiothor you aro bang treated tor cornea! ulcers or for some other bacterial infection in your eye.

Corneal Ulcers

Dosing is eonanuod during tho night time.

Day 1-2 drops every 15 minutes for the first 6 hours and then 2 drope every 30 minutes.

Day 2-2 drops ©very hour.

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

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

Other bacterial infections

1 or 2 drops 4 times a day. For severe infections the doso for the first 2 days may be increased to 1 or 2 drops every 2 hours, whle you are awake.

It is important that you conttnuo to uso CILOXAN for tho full treatment period as

advieod by your doctor won rf your symptoms improve. If yeu stop using this medicine too early, your symptoms may re-occur.

You should not use CILOXAN fcr more than 21 days, untess your doctor says otherwise. Romovo tho looso collar trom tho cap whon tho bottlo is rirst openod.

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 ►

H HOW TO USE CILOXAN'¹ (continued)

How to use

• Wash your hands botoro you start.

• Twist ott tho bottlo cap.

• Mold the bottle pointing down, between your thumb and fingers.

• Tilt your head back.

• Pull down your lower eyeid

with a finger, until there is a ■pocket' between the eyelid and your oyo. Tho drop wfl go in hero (peturo IT

• Bring the bottle tip close to the eye.

Do this in front of a mirror if it he«5p3.

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

• Gently press on tho brew of the bottle to roioaso ono drop at a time (pictiro 2).

• Do not squoozo tho bottlo, cnly a gontto prose on tho bottom is nccdod.

• It you ueo drops in both oyoe, repeat tho steps for your othor oyo. Put tho bottlo 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 ned due. Do

not take a double dose to make up.

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

• If this medicine is accidentally swallowed, I is not likely to cause any serious problems, Uul contact yuur Uoctur.

If you have any further questions on the use

of CILOXAN. ask your doctoi or pharmacist

D POSSIBLE SIDE EFFECTS

Uko all medidnaa, CILOXAN can causa ado otfocts, although not ovorybody gets thorn.

• You may oxporlonco some or all of tho following oftocts in your oyo(e):

Common (1 to 10 users In 100) : White deposits cn tho oyo sutace (comaa), discomfort (stinging or burring, gritty feeing in tno oyo, irritation), redness.

Uncommon (1 to 10 users In 1,000): Damage to tho oyo surtaco (cornea), eonetttvtty to light, blurred vision, swelling of tho cyo or oyolid, pain, dry oyo, ttermoee, oyo aschargo, oyolid crusting, oyolkte sc alee, oyolid rodnose, poor vision, watery oyos, rod oyoe Haro (1 to 10 users in 10,000): Damage of tho eye. inflammation, double vision, decreased eye sensation, fired eyes. stye.

If you notleo whito partlelos in your oyos, corrtinuo to use CILOXAN but toll your doctor immodiatoly.

• You may also oxporlonco oftocts in othor aroas of your body including:

Common : Bad taste.

Uncommon : Headache, nausea.

Rare: Hypersensitivity, clzzhess. ear pain, inflammation inside tho nose, nasal sinus discharge, diarrhoea, a&donnai pain, skin inflammation, tondon dleoroor.

Reporting of sido oftocts If you got any eldo otfocts. taK to your doctor, pharmacist or nureo. This ineludoe any poesiblo side effects not listed in this leaflet. You can also report esdo offocte directly via tho Yellow Card Schema at: www.mfira.gov.Uc/yolkwcard.

By reporting ssde effecta yot can help provide more information on the safety of this medicine. If you experience an allergic reaction, stop using CILOXAN and tell you- doctor.

n HOW TO STORE CILOXAN⁸

• Stop using tho bottlo 58 days attor first oponing, to prevent infections.

• Modianos should not bo lisposod of via wasto wator or household wasto. Ask your pharmacist how to disposo of modicinoe no lenger required. These measvres wll help to protect the environment.

• Do not pa88 this medic no on to others. It may harm them, even if their symptoms are the same as yours

Q FURTHER information

What CILOXAN contains

• The active substance is ciprofloxacin 3 mgfms (as tho hydrochloride).

• The other mgredients are sodum acetate, acetic ackt. mannitol, ©derate disodium, bonzakcnium chloride, n/drochicrtc acad and'or sodium hydroxido (to adjust pH) and purifiod wator.

What CILOXAN looks like and contents of the pack

CILOXAN is a dear, colourless liqiid supplied in a pack containing a 5 ml plastic bottle with a screw cap.

Manufacturer:

SA Alcon-Couvreur NV

Rijkswog 14, B-2870 Puurs Belgium.

Thie loallot was last revised n October 2013.

Alcori

Marketing authorisation holder:

Alcctn Laboratories (UK) Ltd. Fnrrtoy Business Park Frimloy, Camborioy,

Suiroy, GU16 7SR Unsod Kingdom.

06-2013 a Novartis company 33«e-r

Koop out of tho roach and eight of children.

• Do not store above 25°C.

• Do not refrigerate or freeze.

• Keep the bottle tightly closed.

• Do not use the drops after the ewp'ry date (marked 'Exp') on the bottlo and the carton. The expiry date refers to the last day of that month.