Patient Information Leaflet

In this leaflet.

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

2.    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.    Further 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 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.    Before you use Chloramphenicol Eye Ointment

Do not use Chloramphenicol Eye Ointment if you:

•    wear any type of contact lenses.

Take special care with Chloramphenicol Eye ointment if you:

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

•    are pregnant or intending to become pregnant

•    are breast-feeding

•    are taking other medicines

•    you have problems with your blood

(in particular very low numbers of blood cells) after taking chloramphenicol

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

Please tell your doctor, if you are using this medicine and develop signs of irritation or sensitivity.

Taking other medicines

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.

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 doctor or pharmacist before using this product.

Pregnancy and breast-feeding

Chloramphenicol Eye Ointment should not be used by pregnant women or women who are breast-feeding unless necessary. If you are pregnant or breastfeeding you should discuss this with your doctor before you start to apply the ointment.

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 usual 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.

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.

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.    You may use the mirror to help you seeing what you are doing.

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 step from 3 to 6.

8.    Replace the cap securely after use.

Overdose

There is no experience of an over dosage with Chloramphenicol Eye Ointment which is unlikely when given as ointment. If you accidentally swallow it contact your doctor. If you use more Chloramphenicol Eye Ointment than you should If you accidentally use too much 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.

As with other eye preparations, you may occasionally experience eye irritation or visual blurring after initial insertion. If this persists, increases, or if you notice any other changes, stop using your medicine and contact your doctor or pharmacist immediately.

Sometimes, when an antibiotic is used for a long time, other types of bacteria or fungi, which are not killed, take over from the original infection. This may seem as if the original infection has not cleared up or has got worse.

Therefore, if you do not get better, tell your doctor at once, he/she may need to change your treatment.

If you notice any of the following side effects:

•    breathing problems

•    fever

•    swelling of your face, lips or tongue

•    rash with swelling of the skin

Very rare:

•    bruising, bleeding, infections and weakness.

You must stop using the ointment and tell your doctor immediately, if any of the side effects gets serious or 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, 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 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 reach and sight of Children. Do not store the tube at a temperature 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.

6.    Further 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 gm. This product also contains liquid paraffin and white petroleum as excipients

What Chloramphenicol Eye Ointment looks like and contents of the pack

Each tube of Chloramphenicol 1% Eye Ointment contains 4 grams of ointment.

Manufacturer

Excelvision

27, rue de la Lombardiere BP 131

07100 Annonay France

Marketing Authorisation Holder

Medicom Healthcare Ltd.,

235 Hunts Pond Road, Fareham, Hampshire, PO14 4PJ, U.K.

PL number 18956/0005

Hard to see or read the leaflet?

Call: +44 (0)1489 574119

This leaflet was last approved in:

04/2014.

CHLORAMPHENICOL 1%W/W EYE OINTMENT

Patient Information Leaflet

In this leaflet.

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

2.    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.    Further 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 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.    Before you use Chloramphenicol Eye Ointment

Do not use Chloramphenicol Eye Ointment if you:

•    wear any type of contact lenses.

Take special care with Chloramphenicol Eye ointment if you:

•    are sensitive/allergic to any of the

ingredients in this product

•    are pregnant or intending to become

pregnant

•    are breast-feeding

•    are taking other medicines

•    you have problems with your blood

(in particular very low numbers of blood cells) after taking chloramphenicol

have had blood or bone marrow problems.

Please tell your doctor, if you are using this medicine and develop signs of irritation or sensitivity.

Taking other medicines

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 recently taken

any other medicines, including medicines obtained without any prescription.

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 doctor or pharmacist before using this product.

Pregnancy and breast-feeding

Chloramphenicol Eye Ointment should not be used by pregnant women or women who are breast-feeding unless necessary. If you are pregnant or breastfeeding you should discuss this with your doctor before you start to apply the ointment.

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 usual 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.

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.

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.    You may use the mirror to help you seeing what you are doing.

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 step from 3 to 6.

8.    Replace the cap securely after use. Overdose

There is no experience of an over dosage with Chloramphenicol Eye Ointment which is unlikely when given as ointment. If you accidentally swallow it contact your doctor. If you use more Chloramphenicol Eye Ointment than you should If you accidentally use too much 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.

As with other eye preparations, you may occasionally experience eye irritation or visual blurring after initial insertion. If this persists, increases, or if you notice any other changes, stop using your medicine and contact your doctor or pharmacist immediately.

Sometimes, when an antibiotic is used for a long time, other types of bacteria or fungi, which are not killed, take over from the original infection. This may seem as if the original infection has not cleared up or has got worse.

Therefore, if you do not get better, tell your doctor at once, he/she may need to change your treatment.

If you notice any of the following side effects:

•    breathing problems

•    fever

•    swelling of your face, lips or tongue

•    rash with swelling of the skin

Very rare:

•    bruising, bleeding, infections and weakness.

You must stop using the ointment and tell your doctor immediately, if any of the side effects gets serious or if you notice any side effects not listed

please tell your doctor or pharmacist.

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 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 reach and sight of Children.

Do not store the tube at a temperature 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.

6.    Further information

What Chloramphenicol Eye Ointment contains

The active ingredient is chloramphenicol. The ointment contains 1% chloramphenicol which is the equivalent to 10 mg of chloramphenicol per gm. This product also contains liquid paraffin and white petroleum as excipients

What Chloramphenicol Eye Ointment looks like and contents of the pack

Each tube of chloramphenicol 1% Eye Ointment contains 4 grams of ointment.

Manufacturer

TUBILUX PHARMA S.P.A

via Costarica 20/22, 00071 Pomezia (RM)

Italy

Marketing Authorisation Holder

Medicom Healthcare Ltd.,

235 Hunts Pond, Fareham,

Hampshire, PO14 4PJ, U.K.

PL number 18956/0005

Hard to see or read the leaflet?

Call: +44 (0)1489 574119

This leaflet was last revised in:

10/2015.