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CHLOROMYCETIN 1 % W/W OPHTHALMIC OINTMENT

Active substance(s): CHLORAMPHENICOL / CHLORAMPHENICOL / CHLORAMPHENICOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Chloromycetin® 1% w/w Ophthalmic Ointment
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.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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 your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
The product is known by the name above but will be referred to as Chloromycetin Ophthalmic
Ointment throughout the rest of this leaflet.
What is in this leaflet
1. What Chloromycetin Ophthalmic Ointment is and what it is used for
2. What you need to know before you use Chloromycetin Ophthalmic Ointment
3. How to use Chloromycetin Ophthalmic Ointment
4. Possible side effects
5. How to store Chloromycetin Ophthalmic Ointment
6. Contents of the pack and other information
1. What Chloromycetin Ophthalmic Ointment is and what it is used for
Chloramphenicol belongs to a group of medicines called antibiotics. Chloromycetin Ophthalmic
Ointment is used for the treatment of bacterial conjunctivitis (infection of the eye) in adults and
children. 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.
You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

2. What you need to know before you use Chloromycetin Ophthalmic Ointment
DO NOT use Chloromycetin Ophthalmic Ointment if:
• if you are allergic to chloramphenicol or any of the other ingredients of this medicine (listed in
section 6).
• you or someone in your family ever had a blood disorder or bone marrow disease including
anemia (decrease in the number of red blood cells). Signs of this include tiredness, unusual
bruising or increase in the number of infections that you get.
Warnings and precautions
Talk to your doctor or pharmacist before using Chloromycetin Ophthalmic Ointment if:

• you have visual disturbances
• you have severe pain in the eye
• you are sensitive to light
• your eye is inflamed and you have a rash on the scalp or face
• your eye looks cloudy
• the black or coloured part of the eye looks unusual
• you have a foreign body in the eye
• you have an eye infection that keeps coming back
• you have glaucoma (raised pressure in the eye)
• you have dry eyes
• you have eye injury or eye surgery
• you are currently using any other eye drops or eye ointment.
• you regularly use contact lenses. You should only wear contact lenses 24 hours after you have
finished this treatment. You can wear your glasses while using this medicine.
If any new infection appears during treatment, you should stop using the ointment and speak to
your doctor.
If you use Chloromycetin Ophthalmic Ointment for a long time, your doctor may do some blood
tests to check for any problems.
Other medicines and Chloromycetin Ophthalmic Ointment:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines They may be affected by Chloramphenicol or affect how well the ointment works.
In particular, tell your doctor if you are taking any of the following:
• medicines for cancer such as methotrexate
• medicines for the immune system such as azathioprine
Pregnancy, breast-feeding and fertility
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. The ointment should not be
used in pregnancy unless your doctor feels that it is clearly needed, as the effects are unknown.
The ointment should not be used whilst breast feeding.
Driving and using machines
If the ointment blurs your vision, do not drive or operate machines until you can clearly see
again.
3. How to use Chloromycetin Ophthalmic Ointment
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Adults and children: The recommended dosage is a small amount of the ointment to be applied
to the affected eye every 3 hours or more frequently if required.
It is quite possible to use the ointment on your own, but you may find it easier to ask someone
else to put the ointment in your eye.

Let them stand behind you while you sit in a chair.
Paediatric population
Dosage adjustment 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.
Directions for use:
1. Wash and dry your hands
2. Open the tube. Be careful not to touch or breathe on the tip of the tube
3. Tilt your head backwards while seated or lying down on your back
4. Look straight upwards and gently pull the lower lid downwards to uncover the lower part of
your eye ball. This exposes the inner surface of the lower eyelid and is a good place to apply the
ointment
5. Squeeze the tube and apply about 1cm of the ointment to the inner surface of the lower eyelid.
Make sure the tip of the tube does not touch the eye or skin around the eye and your fingers
6. Repeat steps 4 to 5 for the second eye if it is infected
7. Replace the cap securely after use. Make sure your fingers do not touch the tip of the tube.
The ointment must NOT be taken by mouth. If you accidentally swallow any of the ointment,
you should contact your doctor or pharmacist at once.
After starting to use your Chloromycetin Ophthalmic Ointment:
• Symptoms should start to improve after 24 hours. If symptoms do not improve in 48 hours,
speak to your doctor.
• Repeated use or long periods of treatment with Chloromycetin Ophthalmic Ointment can cause
the infection to become resistant to treatment
• Seek immediate medical advice if symptoms worsen at any time
• If you have a severe infection, you may also be given antibiotics to take by mouth.
If you use more Chloromycetin Ophthalmic Ointment than you should
If you accidently apply too much ointment, you should wash your eye with plenty of water for at
least 15 minutes. If any painful symptoms continue after this, you should tell your doctor
immediately.
If you forget to use Chloromycetin Ophthalmic Ointment
If you forget to apply a dose, apply it as soon as you remember unless it is time for your next
dose.
Do not apply a double dose to make up for a forgotten dose.
If you stop using Chloromycetin Ophthalmic Ointment
If you stop treatment with Chloromycetin Ophthalmic Ointment before completing treatment
your eye infection may not completely clear. Speak to your doctor or pharmacist before stopping
Chloromycetin Ophthalmic Ointment.
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.
Along with the relief of symptoms a medicine may produce side effects. Most people using this
medicine find it causes no problems. A few people can be allergic to Chloromycetin Ophthalmic
Ointment.
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 your face, lips or tongue, itching or rash
with swelling of the 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 side effects:
Not known (frequency cannot be estimated from the available data)
• You may notice that your eyes burn or sting for a short while after using the ointment. If
prolonged irritation, swelling, watery eyes or sensitivity to light occurs, then the exposed eye
should be washed with water for 15 minutes. If the symptoms continue after this, an eye
examination may be required.
• Fever
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 on this leaflet. You can also report side effects directly via the Medicines
and Healthcare Products Regulatory Agency yellow card scheme: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information about the safety of this
medicine.
5. How to store Chloromycetin Ophthalmic Ointment
Keep this medicine out of the sight and reach of children.
Do not store above 25oC.
Do not use this medicine after the expiry/use by date on the tube or carton. The expiry date refers
to the last day of that month. Discard the ointment 28 days after opening.
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 Chloromycetin Ophthalmic Ointment contains
The active substance is chloramphenicol. Each 1 gram of ointment contains 10milligrams of
Chloramphenicol. The other ingredients are liquid paraffin, polyethylene in paraffin liquid.
What Chloromycetin Ophthalmic Ointment looks like and contents of the pack
Chloromycetin Ophthalmic Ointment is a smooth uniform translucent greasy ointment.
Chloromycetin Ophthalmic Ointment is supplied in a 4 gram laminate tube with a nozzle.

Marketing Authorisation Holder: Mercury Pharmaceuticals Ltd., Capital House, 85 King
William Street, London EC4N 7BL, UK
Manufacturer: Sanochemia Pharmazeutika AG, Landegger Strasse 7, 2491 Neufeld/Leitha,
Austria
This leaflet was last revised in April 2016.
Mercury Pharmaceuticals is licensed to use the registered trademark Chloromycetin

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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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