Chloramphenicol 0.5 % W/V Eye Drops Solution
CHLORAMPHENICOL 0.5% W/V EYE DROPS, SOLUTION
[Chloramphenicol]
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 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 Chloramphenicol 0.5% w/v Eye Drops, Solution are and what they are used for
2. Before you use Chloramphenicol 0.5% w/v Eye Drops, Solution
3. How to use Chloramphenicol 0.5% w/v Eye Drops, Solution
4. Possible side effects
5. How to store Chloramphenicol 0.5% w/v Eye Drops, Solution
6. Further information
1. What Chloramphenicol 0.5% w/v Eye Drops, Solution are and what they are used for
For the treatment of bacterial conjunctivitis (inflammation of the eye) caused by organisms such as Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus haemolyticus, Morax-Axenfeld and others in both adults and children.
2. Before you use Chloramphenicol 0.5% w/v Eye Drops, Solution Do not use Chloramphenicol:
• If you are allergic (hypersensitive) to Chloramphenicol or any of the other ingredients of Chloramphenicol Eye Drops (See section 6, further information)
• If you have a family history of blood disorders such as aplastic anaemia (not producing enough blood cells). Take special care with Chloramphenicol 0.5% w/v Eye Drops, Solution
• When using in newborns and small children as it has been associated with childhood cancers and Gray baby syndrome in newborns.
• If any new infection appears during treatment, you should stop using the drops and speak to your doctor. If you use the drops for a long time, your doctor may do some blood tests to check for any problems.
Talk to your doctor or pharmacist before using these eye drops if:
• You have visual disturbances
• You have severe pain in your eye
• You are sensitive to light
• Your eye is inflamed and you have a rash on your scalp or face
• Your eye looks cloudy
• The black or coloured part of your eye looks unusual
• You have a foreign body in your eye
• You have an eye infection that keeps coming back
• You have glaucoma
• You have dry eyes
• You have had an eye injury or eye surgery in the last 6 months
• You are currently using any other eye drops or eye ointment
• You use contact lenses
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Use of medicines that can cause bone marrow function (production of blood cells) to be reduced should be avoided.
Pregnancy and breastfeeding
Use in pregnancy and breastfeeding is not recommended and should only be used if considered essential by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
The use of eye drops can cause blurred vision. You should not drive or operate hazardous machinery unless your vision is clear.
Important information about some of the ingredients of Chloramphenicol 0.5% w/v Eye Drops, Solution
This medicine also contains phenylmercuric nitrate as a preservative and it is possible that you may experience an allergic reaction. Tell your doctor if you have any known allergies.
3. How to use Chloramphenicol 0.5% w/v Eye Drops, Solution
Always use Chloramphenicol Eye Drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The recommended dosage for adults (including the elderly), children and infants of all age groups is two drops to be applied to the affected eye every three hours, or more frequently if required.
Treatment should be continued for at least 48 hours after the eye appears normal.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Use in children
Dosage adjustments may be necessary in newborn infants because of reduced systemic elimination due to immature metabolism and the risk of dose-related adverse effects. The maximum duration of treatment is 10-14 days.
4. Possible Side Effects
Like all medicines, Chloramphenicol Eye Drops can cause side effects, although not everybody gets them.
Stop using the medicine and tell your doctor or pharmacist immediately if you experience the following side effects:
• Wheeziness (shortness of breath), fever, swelling of your face, lips or tongue, closing of the throat, itching, rash or redness with swelling of the skin (rash may look swollen or blotchy, or look like little blisters).
Other reactions can include:
• Hypersensitivity (allergic reactions) including burning, itching, stinging and dermatitis (inflammation of the skin)
• Aplastic anaemia(not producing enough blood cells)
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 of side effects you can help provide more information on the safety of this medicine.
5. How to store Chloramphenicol 0.5% w/v Eye Drops, Solution
Keep out of the reach and sight of children.
Store in the fridge between 2°C and 8°C. Keep the bottle in the outer carton to protect from light.
Do not use Chloramphenicol 0.5% w/v Eye Drops, Solution after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information
What Chloramphenicol 0.5% w/v Eye Drops, Solution contains
The active substance is Chloramphenicol 0.5% w/v
The other ingredients are Borax, Boric acid, Phenyl mercuric nitrate, Purified water
What Chloramphenicol 0.5% w/v Eye Drops, Solution looks like and contents of the pack
A flexible polypropylene bottle, incorporating a polyethylene plug and cap assembly.
Chloramphenicol Eye Drops is a bright colourless to yellow aqueous solution. The bottles contain 5ml or 10ml. Marketing Authorisation Holder
Co-pharma Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS.
Manufacturer
Patheon UK Limited
Kingfisher Drive, Swindon, Wiltshire, SN3 5BZ.
This medicinal product is authorised in the Member States of the EEA under the following names:
Not applicable
This leaflet was last revised in August 2016.
Size: 120 x 160 mm 09.08.16