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CHLORAMPHENICOL 0.5 % W/V EYE DROPS SOLUTION

Active substance(s): CHLORAMPHENICOL

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F.P.O
Package leaflet: Information for the user

CHLORAMPHENICOL 0.5% W/V EYE DROPS, SOLUTION
[Chloramphenicol]

Size: 120 x 160 mm

F.P.O

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.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.

If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Chloramphenicol 0.5% w/v Eye Drops, Solution is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1. What Chloramphenicol 0.5% w/v Eye Drops, Solution is and what it is used for
Chloramphenicol 0.5% w/v Eye Drops, Solution contains the active substance chloramphenicol. Chloramphenicol belongs to
a group of medicines called antibiotics. An antibiotic is a medicine which is used for the treatment of a variety of infections
caused by bacteria.
Chloramphenicol 0.5% w/v Eye Drops, Solution is used 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 over 2 years of age.
2. What you need to know before you use Chloramphenicol 0.5% w/v Eye Drops, Solution
Do not use Chloramphenicol 0.5% w/v Eye Drops, Solution:

If you are allergic to chloramphenicol or any of the other ingredients of this medicine (listed in section 6)

If you have a family history of blood disorders such as aplastic anaemia (not producing enough blood cells)

If you have ever had problems with your bone marrow or blood when using chloramphenicol in the past

To treat a child less than 2 years old.
Warnings and precautions
Talk to your doctor or pharmacist before using Chloramphenicol 0.5% w/v Eye Drops, Solution 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 (raised pressure in the eye)

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.
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.
Other medicines and Chloramphenicol 0.5% w/v Eye Drops, Solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, tell your
doctor if you are taking the dietary supplement chymotrypsin.
Use of medicines that can cause bone marrow function (production of blood cells) to be reduced, such as medicines used
to treat cancer, should be avoided.
Pregnancy and breast-feeding
Chloramphenicol 0.5% w/v Eye Drops, Solution should not be used during pregnancy and breast-feeding unless considered
essential by your doctor, as the effects are unknown.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist
for advice before using this 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.

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Chloramphenicol 0.5% w/v Eye Drops, Solution contains boric acid and borax
Do not give to a child less than 2 years old as this medicine contains boron and may impair fertility in the future.
Chloramphenicol 0.5% w/v Eye Drops, Solution contains phenyl mercuric nitrate
This may cause allergic reactions.
3. How to use Chloramphenicol 0.5% w/v Eye Drops, Solution
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Use in adults (including the elderly) and children over 2 years of age
The recommended dosage is two drops to be applied to the affected eye every three hours.
Treatment should be continued for at least 48 hours after the eye appears normal.
Use in children under 2 years of age
This product should not be used in children under 2 years of age.
If you use more Chloramphenicol 0.5% w/v Eye Drops, Solution than you should
Chloramphenicol 0.5% w/v Eye Drops, Solution is for external use only. If you suspect someone has swallowed any, contact
your doctor or go to the accident and emergency department of your local hospital at once. Always take the container with
you, if possible, even if empty.
If you accidentally apply too many drops, you should wash your eye with plenty of water, if any painful symptoms continue
after this, you should tell your doctor immediately.
If you forget to use Chloramphenicol 0.5% w/v Eye Drops, Solution
If you miss a dose, do not worry, just carry on as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, this medicine 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, itching or rash with swelling of skin (the
rash could be puffy (swollen) or blotchy, or look like little blisters)

A sore 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.
Other reactions can include:

Hypersensitivity (allergic reactions) including burning, itching, stinging and dermatitis (inflammation of the skin)

Bone marrow depression (a condition where the marrow is unable to produce red blood cells)

A reduced production and death of red blood cells (anaemia).
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 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.
5. How to store Chloramphenicol 0.5% w/v Eye Drops, Solution
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C). Keep the bottle in the outer carton in order 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. 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 0.5% w/v Eye Drops, Solution contains
The active substance is chloramphenicol 0.5% w/v.
The other ingredients are Borax (see section 2), Boric acid (see section 2), Phenyl mercuric nitrate (see section 2), 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 0.5% w/v Eye Drops,
Solution is a bright, colourless to yellow aqueous solution. The bottles contain 5ml or 10ml.
Marketing Authorisation Holder
Co-pharma
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS.
Manufacturer
Patheon UK Limited
Kingfisher Drive, Swindon, Wiltshire, SN3 5BZ.
This leaflet was last revised in February 2018.

F.P.O
Size: 120 x 160 mm

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