Ciprofloxacin 0.3% W/V Eye Drops
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Package Leaflet - Information for the User
Ciloxan® 0 .3% w/v Eye Drops (ciprofloxacin (as hydrochloride))
The name of your medicine is Ciloxan 0.3% w/v Eye Drops. Throughout this leaflet it will be referred to as 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.
1. What Ciloxan is and what it is used for 4. Possible side effects
1
Ciloxan belongs to a group of medicines It is used for the treatment of corneal ulcers
known as quinolone antibiotics. and some other bacterial infections of the
eye(s).
2
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.
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.
Continued over ►
HOW TO USE CILOXAN (continued)
3
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 B 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.
• You may also experience effects in other areas of your body including:
Common: Bad taste.
Uncommon: Headache, nausea.
Rare: Hypersensitivity, dizziness, ear pain, stye, inflammation inside the nose, nasal sinus discharge, diarrhoea, abnormal pain, skin inflammation, drug intolerance, abnormal laboratory tests.
If any of the side effects get serious, or you
notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
If you experience an allergic reaction, stop using Ciloxan and tell your doctor.
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.
5
HOW TO STORE CILOXAN
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Store upright.
• Keep the bottle tightly closed.
• 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.
• Stop using the bottle 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
• If you notice any sign of discolouration or deterioration of your medicine, please tell your pharmacist immediately.
6
FURTHER INFORMATION
What Ciloxan contains
• Each ml contains 3.5 mg of ciprofloxacin hydrochloride (equivalent to 3.0 mg of ciprofloxacin).
• The other ingredients are disodium edetate, mannitol, acetic acid, sodium acetate, sodium hydroxide and/or hydrochloric acid and purified water.
• It also contains 0.06 mg of benzalkonium chloride in each ml of solution as a preservative.
What Ciloxan looks like and contents of the pack
Ciloxan is supplied as a clear and colourless to pale yellow, sterile solution in a 5 ml dropper bottle.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Laboratoires Alcon Cusi, E-08320, El Masnou-Barcelona, Spain.
Ciloxan 0.3% w/v Eye Drops
PL No: 18067/0247 |POM|
Ciloxan® is a registered trademark of Alcon Inc, Switzerland.
This leaflet was last approved on 14th January 2014.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.
500559/PL1c
Package Leaflet - Information for the User
Ciprofloxacin 0 .3% w/v Eye Drops (ciprofloxacin (as hydrochloride))
The name of your medicine is Ciprofloxacin 0.3% w/v Eye Drops. Throughout this leaflet it will be referred to as 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
4. Possible side effects
5. How to store Ciprofloxacin
6. Further information
1. What Ciprofloxacin is and what it is used for
2. Before you use Ciprofloxacin
3. How to use Ciprofloxacin
1
Ciprofloxacin belon gs to a g roup of medicines It is used for the treatment of corneal ulcers
known as quinolone antibiotics. and some other bacterial infections of the
eye(s).
2
BEFORE YOU USE
Do not use Ciprofloxacin...
• 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 Ciprofloxacin in your eyes.
• Only use Ciprofloxacin in children younger than 1 year if prescribed by your doctor.
• As with any antibiotic, use of Ciprofloxacin 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 Ciprofloxacin. 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 Ciprofloxacin.
Driving and using machines
If your sight is temporarily blurred or affected in any way following use of Ciprofloxacin you should not drive or operate machinery until your vision is clear again.
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 Ciprofloxacin (benzalkonium chloride) that may cause eye irritation and can discolour soft contact lenses. Do not wear contact lenses (hard or soft) during treatment with Ciprofloxacin.
3
HOW TO USE
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 Ciprofloxacin 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 Ciprofloxacin 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 Ciprofloxacin 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 CIPROFLOXACIN
3
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 Ciprofloxacin, do not
worry, just use it when it is next due. Do not take a double dose to make up.
• If you use more Ciprofloxacin 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 Ciprofloxacin, ask your doctor or pharmacist.
4 B POSSIBLE SIDE EFFECTS
Like all medicines, Ciprofloxacin 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 Ciprofloxacin 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, stye, inflammation inside the nose, nasal sinus discharge, diarrhoea, abnormal pain, skin inflammation, drug intolerance, abnormal laboratory tests.
If any of the side effects get serious, or you
notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
If you experience an allergic reaction, stop using Ciprofloxacin and tell your doctor.
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.
5
HOW TO STORE
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Store upright.
• Keep the bottle tightly closed.
• 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.
• Stop using the bottle 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
• If you notice any sign of discolouration or deterioration of your medicine, please tell your pharmacist immediately.
6
FURTHER INFORMATION
What Ciprofloxacin contains
• Each ml contains 3.5 mg of ciprofloxacin hydrochloride (equivalent to 3.0 mg of ciprofloxacin).
• The other ingredients are disodium edetate, mannitol, acetic acid, sodium acetate, sodium hydroxide and/or hydrochloric acid and purified water.
• It also contains 0.06 mg of benzalkonium chloride in each ml of solution as a preservative.
What Ciprofloxacin looks like and contents of the pack
Ciprofloxacin is supplied as a clear and colourless to pale yellow, sterile solution in a 5 ml dropper bottle.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Laboratoires Alcon Cusi, E-08320, El Masnou-Barcelona, Spain.
Ciprofloxacin 0.3% w/v Eye Drops
PL No: 18067/0247 |POM|
This leaflet was last approved on 14th January 2014.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.
500000/PL1c