PACKAGE LEAFLET: INFORMATION FOR THE USER

Chloramphenicol 1% w/w Eye Ointment

Chloramphenicol

D03299

Please read this leaflet carefully before you start to take your medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please 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 you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Chloramphenicol Eye Ointment is and what it is used for

2.    What you need to know before you use Chloramphenicol Eye Ointment

3.    How to use Chloramphenicol Eye Ointment

4.    Possible side effects

5.    How to store Chloramphenicol Eye Ointment

6.    Contents of the pack and other information

1.    What Chloramphenicol Eye Ointment is and what it is used for

Chloramphenicol Eye Ointment is used to treat acute bacterial conjunctivitis, which is an infection of the outer surface of the eye that causes redness, discomfort and discharge from the affected eye.

Your doctor can provide further advice about these symptoms.

The active ingredient of Chloramphenicol Eye Ointment is chloramphenicol, which is an antibiotic.

2.    What you need to know before you use Chloramphenicol Eye Ointment

Do not use Chloramphenicol Eye Ointment if you:

•    are sensitive/allergic to chloramphenicol or to any of the other ingredients in this product

•    wear any type of contact lenses.

•    you, or anyone in your family, have had blood or bone marrow problems

Take special care with Chloramphenicol Eye 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 eye)

•    you have dry eyes

•    you have eye injury or eye surgery

•    you are currently using any other eye drops or eye ointment.

•    you are pregnant or intending to become pregnant.

•    you are breast-feeding

•    you are taking other medicines

•    you have problems with your blood (in particular very low numbers of blood cells) after taking of chloramphenicol

Other medicines and Chloramphenicol Eye Ointment

Please tell your doctor or pharmacist if you are applying any other type of eye drops or eye ointment before you start to use this medicine. Your medicine may affect their action and could alter their effect. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without any prescription.

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 before taking this medicine.

Driving and using machines

Do not drive or operate machines if you have blurred vision after using Chloramphenicol Eye Ointment. You should wait until this clears before driving or using machines.

3. How to use Chloramphenicol Eye Ointment

Always use Chloramphenicol Eye Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose for adults, children and infants of all age groups is as follows:

A small amount of ointment to be applied into the affected eye (every three hours or more frequently if required), as directed by your doctor.

Chloramphenicol may not work against certain types of infections. If your symptoms are not getting better you should tell your doctor immediately.

You should continue to use Chloramphenicol Eye Ointment for 48hrs after the eye appears normal.

If you use Chloramphenicol Eye Ointment for a long time, your doctor may want to take blood samples to make sure the chloramphenicol has not affected your blood in any way.

The contents are sterile until the seal is broken. Do not use if the seal is broken before first opening.

Always wash your hands before applying the eye ointment.

Apply your eye ointment in the following way:

1.    Remove the cap.

2.    Take special care that the nozzle of the tube does not touch your eye, the skin around your eye or your fingers.

3.    Use a mirror to help you seeing what you are doing.

Continued overleaf

4.    Place the nozzle of the tube close to your eye and gently pull the lower eyelid downwards and look up.

5.    Squeeze the tube gently and apply about 1 cm of ointment to the space between the lower eyelid and the eye.

6.    Close your eye for a moment.

7.    Where both eyes are to be treated repeat steps from 3 to 6.

8.    Replace the cap securely after use.

If you use more Chloramphenicol Eye Ointment than you should If you accidentally use too much Chloramphenicol Eye Ointment or swallow your ointment, contact your doctor or go to the nearest hospital casualty department immediately.

Always take the remaining ointment in the tube with the label, to enable the doctor or the hospital to identify the medicine.

If you forget to use Chloramphenicol Eye Ointment

If you forget to take a dose, apply it as soon as possible, but if it is almost time for the next dose then miss the skipped dose and return to your normal dosing schedule.

4. Possible side effects

Like all medicines, Chloramphenicol Eye Ointment can cause side effects, although not everybody gets them. Most of these side effects affect only the eye and may not last very long. If you have any severe or persistent side effect you should stop using the ointment and contact your doctor immediately.

If you notice any of the following side effects, you must stop using the ointment and contact your doctor or the nearest hospital emergency department immediately:

Very severe side effects:

•    swelling of your face and neck

•    difficulty in breathing

•    a drop in blood pressure and unconsciousness

•    high temperature

•    rashes that may be red and raised and may blister.

Less severe side effects:

•    allergic reactions that affect only the eyes and can cause redness and itching, with swelling of the eyelids.

When Chloramphenicol Eye Ointment is given by mouth or by injection, it may cause drops of the numbers of all types of blood cells leading to anaemia, infections and easy bruising and bleeding. Very occasionally, these effects cannot be reversed and have been fatal.

Although only very small amounts of chloramphenicol are absorbed from the eye ointment into your bloodstream, there have been reports of these severe effects even with eye ointment.

Tell your doctor immediately if you:

•    notice that you are feeling generally weak and tired, or

•    get another infection or

•    notice easy bleeding or bruising during or shortly after using the drops

Other local side effects:

•    burning or stinging in and around the eye.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: 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 Ointment

Keep out of the sight and reach of children.

Do not store the tube above 25 °C.

Protect from light.

Do not use this medicine for longer than 28 days after first opening the tube.

Any eye ointment left in the tube after this time should be returned to your pharmacist.

Do not use Chloramphenicol Eye Ointment after the expiry date which is stated on the tube and on the carton the tube is packed in.

Medicine 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. Contents of the pack and other information

What Chloramphenicol Eye Ointment contains

The active ingredient is chloramphenicol. The ointment contains 1% chloramphenicol which is equivalent to 10 mg of chloramphenicol per ml.

This product also contains liquid paraffin and white soft paraffin as excipients What Chloramphenicol Eye Ointment looks like and contents of the pack Each tube of Chloramphenicol Eye Ointment contains 4 grams of ointment. Marketing Authorisation Holder Martindale Pharmaceuticals Ltd T/A Martindale Pharma Bampton Road, Romford RM38UG United Kingdom

Manufacturer TUBILUX PHARMA S.P.A.

Via Costarica 20/22 Pomezia 00071 (RM)

ITALY

PL number 00156/0360 If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.

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This leaflet was last revised in:    S

03/2016    §

3299-B

100mm Measurement Verification Bar

MARTINDALE PHARMA

Bampton Road, Harold Hill, Romford, RM3 8UG, UK