Patient leaflet - CILOXAN 0.3% W/V EYE DROPS SOLUTION
Package Leaflet - Information for the User
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 signs of illness 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.
The name of your medicine is Ciloxan 0.3% w/v eye drops, solution but will be referred to as Ciloxan throughout the remainder of this leaflet.
What is in this leaflet
1. What Ciloxan is and what it is used for
2. What you need to know before you use Ciloxan
3. How to use Ciloxan
4. Possible side effects
5. How to store Ciloxan
6. Contents of the pack and other 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. what you need to know 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.
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 temporarily blurred or affected in any way following use of Ciloxan you should not drive or operate machinery until your vision is clear again.
Other medicines and Ciloxan
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). This medicine contains 0.3 mg Benzalkonium Chloride in each 5 ml which is equivalent to 0.06 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye).
If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
3. how to use ciloxanthe recommended dosethis 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).
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 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 (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 the eye surface (cornea), sensitivity to light, blurred vision, swelling of the eye or eyelid, pain, dry eye, itchiness, 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, 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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
If you experience an allergic reaction, stop using Ciloxan and tell your doctor.
5. how to store ciloxan keep out of the sight and reach of children. do not store above 25°c.
- Keep the bottle tightly closed.
- Do not refrigerate or freeze
- Do not use the drops after the expiry date (marked ‘Exp’) on the
bottle and the carton. The expiry date refers to the last day of that month.
- Discard 28 days after first opening.
- 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.
- If your medicine shows any signs of deterioration or
discolouration, consult your pharmacist for advice. If damaged please tell your doctor or pharmacist.
- Do not pass medicine on to others. It may harm them, even if
6. contents of the pack and other informationwhat ciloxan containseach ml of solution contains 3mg of ciprofloxacin (as the hydrochloride). the other ingredients are sodium acetate, mannitol, edetate disodium, glacial acetic acid, benzalkonium chloride as preservative, hydrochloric acid and/or sodium hydroxide (to adjust ph) and purified water.
What Ciloxan looks like and contents of the pack
Ciloxan is a colourless to pale yellow, clear liquid supplied in a plastic bottle with a plastic screw cap. Each pack contains one 5ml bottle.
This medicine is manufactured by: SA Alcon-Couvreur NV. Rikjsweg 14, B-2870 Puurs, Belgium or Alcon Cusi, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain. Procured from within the EU. Product Licence holder: Quadrant Pharmaceuticals Ltd., Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by: Maxearn Ltd., Unit 29, Oakhill Trading Estate, Devonshire Road, Worsley, Manchester, M28 3PT.
PL 20774/1155 – Ciloxan 0.3% w/v eye drops, solution
POM
Date of preparation 4th February 2021
Ciloxan is a registered trademark of Novartis AG
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Contact Quadrant Pharmaceuticals Ltd, Tel: 01204 471 269
L-02–1155–01