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LUMECOL 0.5% W/V EYE DROPS SOLUTION

Active substance(s): CHLORAMPHENICOL / CHLORAMPHENICOL

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Package leaflet: Information for the use
Lumecol 0.5% w/v Eye Drops, Solution
Chloramphenicol
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
The brand name of the medicine is Lumecol 0.5% w/v Eye Drops, Solution and throughout
this leaflet it will be referenced as Chloramphenicol Eye Drops.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist
told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
• You must talk to a doctor if you do not feel better or if you feel worse after 48 hours.
What is in this leaflet
1. What Chloramphenicol Eye Drops are and what they are used for
2. What you need to know before you use Chloramphenicol Eye Drops
3. How to use Chloramphenicol Eye Drops
4. Possible side effects
5. How to store Chloramphenicol Eye Drops
6. Contents of the pack and other information
1. What Chloramphenicol Eye Drops are and what they are used for
Chloramphenicol Eye Drops contain an antibiotic called chloramphenicol. It is used to treat
bacterial infections that affect the front surfaces of the eye.
The most common type of infection in this area is called acute bacterial conjunctivitis. When
you have this condition, the white part of one or both of your eyes will be red and /or your
eyelids will be red or swollen. There will be a sticky discharge, which can make the eye
difficult to open in the morning and the eye may feel ‘gritty’ or ‘irritated’.
Chloramphenicol Eye Drops are not suitable for treating eye infections that have spread to the
deeper layers of the eye coverings or into the fluid within the eyeball. Antibiotic tablets or
injections are needed to treat these deeper, more serious infections.
2. What you need to know before you use Chloramphenicol Eye Drops
Chloramphenicol Eye Drops are recommended for use in children aged 2 years and over, in
adults and the elderly. A child below the age of 2 years with an eye infection should be seen
by a doctor.
Do not use this product if you:
• are allergic to Chloramphenicol or any of the ingredients of this medicine (listed in section
6).
• have ever had problems with your blood (in particular very low number of blood cells)
during previous treatment with chloramphenicol
• have a family history of blood problems such as low white blood cell, red blood cell, or
platelet counts
Do not use this product and seek advice from your doctor if:
• your eyesight is affected (loss of sight, reduced vision, blurred vision or halos around
lights)
• you have pain within the eye

• your eye has suffered a blow or other injury
• your eye is inflamed and you have a rash on the scalp or face
• the pupil of your eye looks unusual or your eye looks cloudy
• your eyes are sensitive to light
• you have (or think you have) a foreign body in your eye, which has not been removed
• you have recently had an eye infection
• you suffer from or have suffered from glaucoma or dry eye syndrome
• you wear contact lenses. If you wear contact lenses and your contact lens practitioner or
doctor has advised you to use this product, do not wear your lenses during the course of
treatment. Wear your glasses instead. Soft contact lenses should not be used for 24 hours
after completing treatment.
• you are using any other eye drops or eye ointment
• you have had eye surgery or laser treatment in the last 6 months
Tell your pharmacist before using this product if you:
• are taking any other medicines
• suffer from any other eye problems.
Other medicines and Chloramphenicol Eye Drops
If you are taking bone marrow depressant medicines (medicines which decrease the activity
of the bone marrow, causing low blood cell counts) such as azathioprine or are receiving
chemotherapy, seek the advice of your pharmacist or your doctor before using this product.
Pregnancy and breast-feeding
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
After using the drops, you may temporarily get blurred vision. Do not drive or operate
machinery until your vision is clear. If in doubt, talk to your pharmacist or doctor.
Chloramphenicol Eye Drops contains phenylmercuric nitrate
Phenylmercuric nitrate may cause allergic reactions.
3. How to use Chloramphenicol Eye Drops
Instructions for use
To be used in the eye(s) only
• Check that the seal is not broken before the first use.
• Wash and dry your hands
• Tilt your head back while seated or lie down on your back
• Gently pull the lower eyelid downwards and look up
• Place the tip of the bottle close to your eye. Squeeze the bottle and let one drop fall into the
space between the lower eyelid and the eye. Take care that the tip of the bottle does not touch
your eye, the skin around your eye or your fingers.
• Close your eye for a moment.
• When both eyes are to be treated, repeat for the other eye
• Replace and tighten the cap immediately after use.
Whilst applying the drops, do not
• breathe on or touch the dropper nozzle
• touch the eyes or eyelids (or any other surface) with the tip of the bottle
• share your eye drops with anyone else.

For external use only.
Dose
Apply one drop to the affected eye(s) every 2 hours for the first two days and every 4
hours thereafter. Use during waking hours only.
Length of treatment
The course of treatment is 5 days. Keep using these eye drops for 5 days. Do not stop just
because you feel better, this could make your condition worse.
If your symptoms do not improve within 48 hours, consult your doctor. If your symptoms
get worse seek medical advice at once.
Do not use Chloramphenicol Eye Drops for more than 5 days without consulting doctor.
Dispose of any remaining eye drops appropriately after the 5 day course of treatment (see
section 5).
If you forget to use your drops
If you have only just missed a dose and it is a long time before the next dose is due, put in the
missed dose of drops straight away. If it is nearly time for your next dose, skip the missed
dose and just put in the next dose of drops at the usual time. Do not take a double dose to
make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some people may get one or more of these side effects. Some effects happen straight away
but do not last long - others may only happen after several days of use.
• Allergic reactions such as itching or rashes. If you get a severe reaction, with swelling or
breathing problems get medical help straight
away.
• Changes in the blood (anaemia) leading to severe tiredness or easy bruising. If you
experience these effects, stop using the drops immediately and tell your doctor.
• Discolouration or clouding of the eye surface (cornea) or lens due to preservative.
• The use of topical Chloramphenicol may occasionally result in the over growth of other non
susceptible organisms including fungi. If any new infection appears during treatment you
should tell your doctor.
• Blurred vision or mild burning or stinging when you put the drops in. These should
subside quickly.
• Irritation of the skin around the eyes, mercurialentis (brown discolouration of the lens)
and atypical band keratopathy (appearance of calcium on the cornea). These may be due to
the preservative in the drops called phenylmercuric nitrate.
If you do not feel well or are worried about your health, talk to a pharmacist or doctor.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
Reporting 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 Chloramphenicol Eye Drops
Replace the cap securely after use. Store in a refrigerator (20C - 80C).
This is the temperature of most domestic refrigerators.
Keep the bottle in the outer carton in order to protect from light.
Keep this and all medicines out of the sight and reach of children.
Do not use after the expiry date which is stated on the bottle and on the carton the bottle is
packed in.
Dispose of any medicine left at the end of a 5 day course of treatment.
Do not throw away any medicines via waste water 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 Eye Drops 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 water for injections.
What Chloramphenicol Eye Drops looks like and contents of the pack
Each bottle contains 10 ml of drops.
The drops contain 0.5% w/v chloramphenicol, which is equivalent to 5 mg of
chloramphenicol per millilitre.
Chloramphenicol Eye Drops is a bright, colourless to faint yellow aqueous solution.
Marketing Authorisation Holder
Medicom Healthcare Ltd
235 Hunts Pond Road,
Titchfield Common Fareham, Hants.
PO14 4PJ, UK.
Manufacturer
Excelvision, 27, rue de la Lombardière, BP 131, 07100 Annonay, France
PL number: 18956/0013
Hard to see or read the leaflet?
Call +44 (0) 1489 574119 for help
This leaflet was last revised in DRAFT 12/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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