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CHLORAMPHENICOL 1 % W/W OPHTHALMIC OINTMENT

Active substance(s): CHLORAMPHENICOL / CHLORAMPHENICOL / CHLORAMPHENICOL

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Package leaflet: Information for the user
Chloramphenicol 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 Chloramphenicol Ophthalmic
Ointment throughout the rest of this leaflet.
What is in this leaflet
1. What Chloramphenicol Ophthalmic Ointment is and what it is used for
2. What you need to know before you use Chloramphenicol Ophthalmic Ointment
3. How to use Chloramphenicol Ophthalmic Ointment
4. Possible side effects
5. How to store Chloramphenicol Ophthalmic Ointment
6. Contents of the pack and other information
1. What Chloramphenicol Ophthalmic Ointment is and what it is used for
Chloramphenicol belongs to a group of medicines called antibiotics. Chloramphenicol
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 Chloramphenicol Ophthalmic Ointment
Do not use Chloramphenicol Ophthalmic Ointment if:
• you are allergic reaction 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, pharmacist or nurse before using Chloramphenicol 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 wear contact lenses. Do not wear contact lenses during this treatment, wear
spectacles. You can wear contact lenses 24 hours after you have finished this treatment.
If any new infection appears during treatment, you should stop using the ointment and speak to
your doctor.
If you use Chloramphenicol Ophthalmic Ointment for a long time, your doctor may do some
blood tests to check for any problems.
Other medicines and Chloramphenicol 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
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. 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
If the ointment blurs your vision, do not drive or operate machines until you can clearly see
again.
3. How to use Chloramphenicol 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 dose 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.
After starting to use your Chloramphenicol 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 Chloramphenicol 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.
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.
If you use more Chloramphenicol Ophthalmic Ointment than you should
If you accidently apply too much ointment, 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 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 Chloramphenicol Ophthalmic Ointment
If you stop treatment with Chloramphenicol Ophthalmic Ointment before completing treatment
your eye infection may not completely clear. Speak to your doctor or pharmacist before stopping
Chloramphenicol Ophthalmic Ointment.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

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 Chloramphenicol
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 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 in 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 on the safety of this medicine.

5. How to store Chloramphenicol Ophthalmic Ointment
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry/use by date which is stated 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 Chloramphenicol Ophthalmic Ointment contains
-The active substance is chloramphenicol. Each 1 gram of ointment contains 10 milligrams of
Chloramphenicol.
-The other ingredients are liquid paraffin, polyethylene in paraffin liquid.
What Chloramphenicol Ophthalmic Ointment looks like and contents of the pack
Chloramphenicol Ophthalmic Ointment is a smooth uniform translucent greasy ointment.
Chloramphenicol Ophthalmic Ointment is supplied in a 4 gram laminate tube with 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
(Sanochemia).
This leaflet was last revised in April 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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