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Chloramphenicol 0.5% W/V Antibiotic Eye Drops

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Document: leaflet MAH GENERIC_PL 00156-0109 change

PACKAGE LEAFLET: INFORMATION FOR THE USER


D01806


Chloramphenicol Antibiotic Eye Drops 0.5%w/v


Chloramphenicol


Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Chloramphenicol Antibiotic Eye Drops carefully to get the best results.

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

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor or pharmacist if your symptoms worsen or do not improve after 2 days.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your pharmacist.


In this leaflet:

1.    What Chloramphenicol Antibiotic Eye Drops are and what they are used for

2.    Before you use Chloramphenicol Antibiotic Eye Drops

3.    How to use Chloramphenicol Antibiotic Eye Drops

4.    Possible side effects

5.    How to store Chloramphenicol Antibiotic Eye Drops

6.    Further information

This leaflet contains a summary of the information available for this medicine. You should ask your pharmacist if you are unsure about any aspect of this medicine.

1.    What Chloramphenicol Antibiotic Eye Drops are and what they are used for

Chloramphenicol belongs to a group of medicines called antibiotics. An antibiotic is a medicine which is used for the treatment of a variety of infections caused by bacteria. Chloramphenicol Antibiotic Eye Drops are used in the treatment of a wide range of eye infections caused by bacteria.

2.    Before you use Chloramphenicol Antibiotic Eye Drops

Do not use Chloramphenicol Antibiotic Eye Drops if:

•    you are allergic (hypersensitive) to chloramphenicol or to any of the other ingredients listed in section 6 of this leaflet.

Take special care with Chloramphenicol Antibiotic Eye Drops.

Tell your doctor or pharmacist if:

•    you have blurred or double vision

•    your eye(s) are more sensitive to light than usual

•    your pupil(s) looks unusual

•    your eye(s) looks cloudy

•    you have pain or swelling around the eye or face

•    you have had an eye infection in the recent past

•    you have glaucoma (a raised pressure in the eye)

•    you have very dry eyes

•    you have an eye injury

•    you have something in your eye

•    you are already using other eye drops or eye ointment

•    you have had eye surgery or laser treatment in the last 6 months

•    you wear contact lenses


•    you or someone in your family suffer from problems with your blood (aplastic anaemia) or bone marrow problems

•    you have ever had an allergic (hypersensitive) reaction to this or any other medicine

•    you are pregnant, trying for a baby or are breast-feeding.

Taking other medicines

Please tell your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Medicines which may interact with Chloramphenicol Antibiotic Eye Drops include:

•    the dietary suppliment chymotrypsin

•    any other medicines that are likely to slow down the bone marrow's production of blood cells (bone marrow depression).

Pregnancy and breast-feeding

Chloramphenicol Antibiotic Eye Drops should not be used if you are pregnant, trying for a baby or are breast-feeding.

Driving and using machines

Chloramphenicol Antibiotic Eye Drops can cause temporary blurring of vision after you have used them. Wait until your vision is clear before driving or using machines.

3. How to use Chloramphenicol Antibiotic Eye Drops

Always read the leaflet before beginning treatment.

If the eye(s) have an obvious discharge or 'crust' they may be bathed with boiled and cooled water before treating with Chloramphenicol Antibiotic Eye Drops.

If you wear contact lenses they must be removed whilst you are using Chloramphenical Antibiotic Eye Drops. You should wait 24 hours after you take your last dose of Chloramphenicol Antibiotic Eye Drops before starting to use your lenses again.

Instructions for use

1.    Wash your hands well before use

2.    Remove the outer cap. If you are putting in the eye drops yourself you should use a mirror

3.    Tilt the head back and pull the lower lid of the eye out to pocket


4.    Hold the container between the thumb and middle finger of the other hand, turn the container upside down

near to the eye, try not to touch the eye with the nozzle


5.    Apply enough pressure to the container to release one to two drops

6.    Blink the eye a few times

7.    If you think that you have missed the eye, then insert another drop

8.    Repeat in the other eye if you have been told to use Chloramphenicol drops in both eyes

9.    Replace the outer cap on the container, trying not to touch the applicator tip with anything, including the eye or the fingers

10.    Wash your hands.

How much to use Adults, the elderly and children over 2 years

Put one drop into the affected eye(s) every 2 hours for the first 48 hours. After this you should reduce the dose to one drop every 4 hours.

Not suitable for children under 2

Do not use Chloramphenicol Antibiotic Eye Drops just before you go to sleep.

The course of treatment should be 5 days. Do not use Chloramphenicol Eye Drops for longer than 5 days at a time.

Seek further immediate medical advice any time if symptoms worsen.

Consult your doctor if your eye infection does not start to improve within 48 hours

Chloramphenicol Antibiotic Eye Drops are for external use only. If you have swallowed or you suspect someone else has swallowed any Chloramphenicol Antibiotic Eye Drops, contact your doctor or go to the accident and emergency department of your local hospital at once. Always take the container with you, if possible, even if empty.

If you forget to use Chloramphenicol Antibiotic Eye Drops

Try not to miss doses. If you do miss a dose do not worry, take your next dose at the normal time. Do not use extra drops to make up.

4. Possible side effects

Like all medicines, Chloramphenicol Antibiotic Eye Drops can cause side effects, although not everybody gets them.

Possible side effects include:

•    burning

•    stinging

•    itching

•    mild stinging

•    inflammation of the skin (dermatitis).

Rare side effects include:

•    damage to parts of the eye

•    bone marrow depression (a condition where the marrow is unable to produce blood cells)

•    a reduced production and death of red blood cells (anaemia)

•    in very young children, grey baby syndrome.

Prolonged use of Chloramphenical Antibiotic Eye Drops is not advised. You should not use this product for longer than 5 days at a time.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store Chloramphenicol Antibiotic Eye Drops

Keep out of the reach and sight of children.

Do not use Chloramphenicol Eye Drops after the expiry date printed on the bottle label. The expiry date refers to the last day of that month. Once the bottle is opened use within 4 weeks.

You are advised to dispose of the bottle once you have finished your five day course of treatment.

This medicine needs to be stored upright between 2-8°C (in a refrigerator). Protect from light. Do not allow it to freeze.

Medicines 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.    Further Information

What Chloramphenicol Antibiotic Eye Drops contain:

The active substance is Chloramphenicol

0.5%w/v

The other ingredients are borax, boric acid, phenylmercuric nitrate and purified water.

What Chloramphenicol Antibiotic Eye Drops look like and contents of the pack

Chloramphenicol Antibiotic Eye Drops is a clear colourless solution supplied in plastic bottles. Each bottle contains 10ml of solution.

Marketing Authorisation Holder and Manufacturer

Martindale Pharmaceuticals Ltd.

Bampton Road, Romford, RM3 8UG, England

Manufacturer

Famar S.A. Alimos Plant 63, AG Dmitriou Str.

Agiou Dmitriou 63

Alimos Attiki

17456

Greece

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

This leaflet was last approved in {08/2011}.

PL 00156/0109

MARTINDALE

Pharmaceuticals y"| Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom

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PACKAGE LEAFLET: INFORMATION FOR THE USER


D01800


Chloramphenicol Antibiotic Eye Drops 0.5%w/v


Chloramphenicol


Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Chloramphenicol Antibiotic Eye Drops carefully to get the best results.

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

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor or pharmacist if your symptoms worsen or do not improve after 2 days.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your pharmacist.


In this leaflet:

1.    What Chloramphenicol Antibiotic Eye Drops are and what they are used for

2.    Before you use Chloramphenicol Antibiotic Eye Drops

3.    How to use Chloramphenicol Antibiotic Eye Drops

4.    Possible side effects

5.    How to store Chloramphenicol Antibiotic Eye Drops

6.    Further information

This leaflet contains a summary of the information available for this medicine. You should ask your pharmacist if you are unsure about any aspect of this medicine.

1.    What Chloramphenicol Antibiotic Eye Drops are and what they are used for

Chloramphenicol belongs to a group of medicines called antibiotics. An antibiotic is a medicine which is used for the treatment of a variety of infections caused by bacteria. Chloramphenicol Antibiotic Eye Drops are used in the treatment of a wide range of eye infections caused by bacteria.

2.    Before you use Chloramphenicol Antibiotic Eye Drops

Do not use Chloramphenicol Antibiotic Eye Drops if:

•    you are allergic (hypersensitive) to chloramphenicol or to any of the other ingredients listed in section 6 of this leaflet.

Take special care with Chloramphenicol Antibiotic Eye Drops.

Tell your doctor or pharmacist if:

•    you have blurred or double vision

•    your eye(s) are more sensitive to light than usual

•    your pupil(s) looks unusual

•    your eye(s) looks cloudy

•    you have pain or swelling around the eye or face

•    you have had an eye infection in the recent past

•    you have glaucoma (a raised pressure in the eye)

•    you have very dry eyes

•    you have an eye injury

•    you have something in your eye

•    you are already using other eye drops or eye ointment

•    you have had eye surgery or laser treatment in the last 6 months

•    you wear contact lenses


•    you or someone in your family suffer from problems with your blood (aplastic anaemia) or bone marrow problems

•    you have ever had an allergic (hypersensitive) reaction to this or any other medicine

•    you are pregnant, trying for a baby or are breast-feeding.

Taking other medicines

Please tell your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Medicines which may interact with Chloramphenicol Antibiotic Eye Drops include:

•    the dietary suppliment chymotrypsin

•    any other medicines that are likely to slow down the bone marrow's production of blood cells (bone marrow depression).

Pregnancy and breast-feeding

Chloramphenicol Antibiotic Eye Drops should not be used if you are pregnant, trying for a baby or are breast-feeding.

Driving and using machines

Chloramphenicol Antibiotic Eye Drops can cause temporary blurring of vision after you have used them. Wait until your vision is clear before driving or using machines.


3. How to use Chloramphenicol Antibiotic Eye Drops

Always read the leaflet before beginning treatment.

If the eye(s) have an obvious discharge or 'crust' they may be bathed with boiled and cooled water before treating with Chloramphenicol Antibiotic Eye Drops.

If you wear contact lenses they must be removed whilst you are using Chloramphenical Antibiotic Eye Drops. You should wait 24 hours after you take your last dose of Chloramphenicol Antibiotic Eye Drops before starting to use your lenses again.

Instructions for use

1.    Wash your hands well before use

2.    Remove the outer cap. If you are putting in the eye drops yourself you should use a mirror

3.    Tilt the head back and pull the lower lid of the eye out to pocket




4.    Hold the container between the thumb and middle finger of the other hand, turn the container upside down

near to the eye, try not to touch the eye with the nozzle

5.    Apply enough pressure to the container to release one to two drops



7.    If you think that you have missed the eye, then insert another drop

8.    Repeat in the other eye if you have been told to use Chloramphenicol drops in both eyes

Replace the outer cap on the container,


Prolonged use of Chloramphenical Antibiotic Eye Drops is not advised. You should not use this product for longer than 5 days at a time.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Chloramphenicol Antibiotic Eye Drops

Keep out of the reach and sight of children. Do not use Chloramphenicol Eye Drops after the expiry date printed on the bottle label. The expiry date refers to the last day of that month. Once the bottle is opened use within


1

trying not to touch the applicator tip with anything, including the eye or the fingers

4 weeks.

You are advised to dispose of the bottle once

1

10. Wash your hands.

How much to use Adults, the elderly and children over 2 years

Put one drop into the affected eye(s) every 2 hours for the first 48 hours. After this you should reduce the dose to one drop every 4 hours.

Not suitable for children under 2

you have finished your five day course of treatment.

This medicine needs to be stored upright between 2-8°C (in a refrigerator). Protect from light. Do not allow it to freeze.

Medicines 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

1

1

Do not use Chloramphenicol Antibiotic Eye Drops just before you go to sleep.

The course of treatment should be 5 days. Do not use Chloramphenicol Eye Drops for longer than 5 days at a time.

Seek further immediate medical advice any time if symptoms worsen.

Consult your doctor if your eye infection does not start to improve within 48 hours

protect the environment.

6. Further Information

What Chloramphenicol Antibiotic Eye Drops contain:

The active substance is Chloramphenicol

0.5%w/v

The other ingredients are borax, boric acid, phenylmercuric nitrate and purified water.

1

1

1

1

Chloramphenicol Antibiotic Eye Drops are for external use only. If you have swallowed or you suspect someone else has swallowed any Chloramphenicol Antibiotic Eye Drops, contact your doctor or go to the accident and emergency department of your local hospital at once. Always take the container with you, if possible, even if empty.

If you forget to use Chloramphenicol

Drops look like and contents of the pack

Chloramphenicol Antibiotic Eye Drops is a clear colourless solution supplied in plastic bottles. Each bottle contains 10ml of solution.

Marketing Authorisation Holder

iCare

Bampton Road, Romford, RM3 8UG, England

Manufacturer

1

1

1

Antibiotic Eye Drops

Try not to miss doses. If you do miss a dose do not worry, take your next dose at the normal time. Do not use extra drops to make up.

4. Possible side effects

Like all medicines, Chloramphenicol Antibiotic Eye Drops can cause side effects, although not everybody gets them.

Farmigea S.p.A

Via G.B. Oliva 8

56121

Pisa

Italy

Famar S.A. Alimos Plant 63, AG Dmitriou Str.

Agiou Dmitriou 63 Alimos Attiki

i

1

_1_

Possible side effects include:

•    burning

•    stinging

•    itching

•    mild stinging

•    inflammation of the skin (dermatitis).

Rare side effects include:

•    damage to parts of the eye

•    bone marrow depression (a condition

17456

Greece

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

This leaflet was last revised in August 2011. PL 00156/0109

1

_i_


where the marrow is unable to produce blood cells)

a reduced production and death of red blood cells (anaemia) in very young children, grey baby syndrome.


are


Continued overleaf