Chloramphenicol Eye Drops Bp 0.5% W/V
Package leaflet: Information for the user
CHLORAMPHENICOL EYE DROPS BP 0.5% w/v
(Chloramphenicol)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, ask your doctor or pharmacist.
« This medicine has been prescribed foryou only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• Ifyou get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• The medicine will be called Chloramphenicol in this leaflet.
What is in this leaflet:
1. What Chloramphenicol is and what it is used for
2. What you need to know before you use Chloramphenicol
3. Howto use Chloramphenicol
4. Possible side effects
5. Howto store Chloramphenicol
6. Contents of the pack and other information
1. WHAT CHLORAMPHENICOL IS AND WHAT IT IS USED FOR Chloramphenicol belongs to a group of medicine called antibiotics.
Chloramphenicol is used in both adults and children to treat bacterial conjunctivitis, which is an infection of the outer surfaces of the eye. The infected eye will probably be red, gritty or itchy. In the morning there will be a sticky discharge which may make it difficult to open the eye. When put in the eye, chloramphenicol works by helping kill the bacteria (germs) and allow the body to overcome the infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORAMPHENICOL Do not use chloramphenicol:
• If you are allergic (hypersensitive) to chloramphenicol orto any other ingredient of this medicine (see section 6 for more details)
« Ifyou or someone inyourfamily ever had a blood disorder or bone marrow disease including anemia (decrease in the number of red blood cells) when using chloramphenicol in the past.
« Ifyou have a family history of “dyscrasias”, a condition which can cause tiredness, bruising and an increased risk of infections Take special care:
• Ifyou develop a new eye infection during this treatment, you should stop using the drops and speak to your doctor.
• Ifyou use chloramphenicol eye drops fora long time, your doctor may do some blood tests to check for any problems.
Warnings and precautions
Talk to your doctor or pharmacist before using chloramphenicol « ifyou have visual disturbances
• ifyou have severe pain in the eye « ifyou are sensitive to light
• if youreye is inflamed and you have a rash on the scalp orface « if youreye looks cloudy
• if your black or coloured part of the eye looks unusual
• ifyou have a foreign body in the eye
. ifyou have an eye infection that keeps coming back
• ifyou have glaucoma (raised pressure in the eye)
• ifyou have dry eyes
• ifyouhaveeyeinjuryoreyesurgery
« ifyou are currently using any other eye drops or eye ointment Other medicines and Chloramphenicol
Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines, including using eye drops or eye ointment and medicines obtained without a prescription before you start to use this medicine. Your medicine may affect theiraction and could altertheireffect.
In particular, tell your doctor ifyou are taking any of the following:
• medicines for cancer such as methotrexate
« medicines forthe immune system such as azathioprine Pregnancy and breast-feeding
Chloramphenicol should not be used during pregnancy and breast-feeding unless considered essential by your doctor, as the effects are unknown.
Ifyou are a pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyourdoctor or pharmacist for advice before using this medicine. Driving and using machines
No effects on ability to drive and use machines have been reported. However do not drive or operate machines ifyou experience any visual disturbance after using the product. Wait until this clears before driving or using machines.
Chloramphenicol contains
Chloramphenicol eye drops contain phenylmercuric nitrate as a preservative which may cause allergic reaction. Do not wear contact lenses during treatment. Wait until 24 hours after the end of the treatment before you wear your contact lenses. You can wear glasses during treatment.
3. HOWTO USE CHLORAMPHENICOL
• Keep the affected eye closed and press yourfingertip against the inside comer of the closed eye, and hold for 1 minute
• Repeat for the other eye if necessary
• Replace and tighten the cap immediately after use.
Be careful not to touch the tip of the bottle on youreye or on any other surface.
Ocular solutions, if handled wrongly, can become contaminated by common bacteria and cause eye infections. If you do develop any other eye condition whilst using this product, see your doctor immediately.
Ifyou use more chloramphenicol than you should
If you accidently apply too much drops, you should wash your eye with plenty of water, if any painful symptoms continue after this, you should tell your doctor immediately.
Ifyou forget to use chloramphenicol
Apply the drops as soon as you remember. However, if it is almost time for your next dose, do not double your dose and carry on with the normal schedule dose.
Ifyou stop using chloramphenicol
To be effective chloramphenicol must be used every day. Do not stop using chloramphnicol until yourdoctortells you so.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Chloramphenicol can cause side effects, although not everybody gets them.
Some people find that their eyes sting or their sight is blurred immediately after using the drops. These effects should wear off after a short time. If prolonged irritation, swelling, watery eyes or sensitivity to light occurs, then exposed eye should be washed with water for 15 minutes. If the symptoms continue after this, an eye examination may be required.
Stop using your medicine and tell your doctor or pharmacist immediately if you experience the following side effects:
• Wheeziness (shortness of breath), fever, swelling of yourface, lips or tongue, itching or rash with swelling of skin (the rash could be puffy (swollen) or blotchy, or look like little blisters.
• Asore throat, bruising or being unable to overcome an infection. On very rare occasions, patients using chloramphenicol have had changes in their blood cells causing severe tiredness or easy bruising.
If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOWTO STORE CHLORAMPHENICOL
Keep this medicine out of the sight and reach of children.
Store in a refrigerator at a temperature between 2°C and 8°C.
Protect from light.
Discard the bottle 28 days after opening, even if there is solution remaining.
Do not use chloramphenicol after the expiry date which is stated on the carton and label after 'EXP'. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Chloramphenicol contains
The active substance is chloramphenicol 0.5% w/v.
The other ingredients are Borax, Boric acid, Phenyl mercuric nitrate (as preservative) 0.002% w/v and purified water.
What Chloramphenicol looks like and contents of the pack Each bottle contains 5ml or 10ml of Chloramphenicol Eye Drops.
Your medicine is a bright, colourless to faint yellow aqueous solution.
Marketing Authorisation Holder and Manufacturer
FDC International Ltd,
Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham,
Hampshire, P015 7FE PL number: 15872/0003
Hard to see or read the leaflet? Call + 44(0) 1489 565222 for help. This leaflet was last revised in: 08/2016
MODE OF USE
Tighten the cap on the nozzle till the cap touches the shoulder.
Tilt head backwards. Dispense drops with gentle pressure. Do not touch dropper tip to the surface of the eye.
Replace cap after every use, and screw the cap down
The spike in the cap will pierce the tip of the bottle.
Colour: CMYK Version 05