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Vistaphenicol Eye Drops

Document: leaflet MAH GENERIC_PL 00156-0048 change

PACKAGE LEAFLET: INFORMATION FOR THE USER    D01677


Chloramphenicol Eye Drops 0.5% w/v


Chloramphenicol



Read all this leaflet carefully before you use Chloramphenicol Eye Drops

•    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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours

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


In this leaflet:

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

2.    Before you use Chloramphenicol Eye Drops

3.    How to use Chloramphenicol Eye Drops

4.    Possible side effects

5.    Storing Chloramphenicol Eye Drops

6.    Further information

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

1.    What Chloramphenicol 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 Eye Drops are used in the treatment of a wide range of eye infections caused by bacteria.

2.    Before you use Chloramphenicol Eye Drops

Do not use Chloramphenicol Eye Drops if:

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

Take special care with Chloramphenicol Eye Drops.

Tell your doctor or pharmacist if:

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

•    you wear contact lenses

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

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

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

Medicines which may interact with Chloramphenicol Eye Drops include:

•    the dietary supplement chymotrypsin


• any other medicines that are likely to slow down the bone marrow's production of red blood cells (bone marrow depression). Pregnancy and breast-feeding Chloramphenicol Eye Drops should not be used if you are pregnant, trying to become pregnant or are breast-feeding, unless your doctor has specifically recommended it.

Driving and using machines Chloramphenicol Eye Drops can cause temporary blurring of vision after application. Wait until your vision is clear before driving or using machines.

3. How to use Chloramphenicol 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 Eye Drops.

Contact lenses should be taken out before treatment with Chloramphenicol Eye Drops.

Instructions for use

1.    Wash your hands well before use

2.    Remove the outer cap. You may find it easier to apply your drops in front of a mirror.

3.    Tilt the head back and pull the lower lid of the eye out to form a 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 Eye 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.

Continued overleaf



How much to use

One to two drops should be applied to each affected eye up to six times daily or more frequently if required. Severe infections may require one or two drops every fifteen to twenty minutes initially; reducing the frequency of use as the infection is controlled.

Do not use Chloramphenicol Eye Drops more often or for a longer period than your doctor has directed.

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

Chloramphenicol Eye Drops are for external use only. If you suspect someone has swallowed any Chloramphenicol 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 Eye Drops

Try not to miss doses. If you do miss a dose, do not worry, just carry on as normal. Do not use extra drops to make up.

4. Possible side effects

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

Possible side effects include:

•    burning

•    stinging

•    itching

•    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 red blood cells)

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

•    in very young children, grey baby syndrome.

Serious side effects are possible if you are pregnant. If you become pregnant during your course of treatment, stop immediatly and consult you doctor.

Prolonged use of Chloramphenicol Eye Drops is not advisable. You should not use this product for longer than 5 days at a time unless your doctor has told you otherwise.

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.    Storing Chloramphenicol 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 the month. Once you have opened the bottle use within 4 weeks.

You are advised to dispose of the bottle once you have finished your 5 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 Eye Drops contains

The active ingredient is Chloramphenicol 0.5% w/v.

The other ingredients are Purified Water, Boric Acid, Borax and Phenylmercuric Nitrate 0.002% w/v.

What Chloramphenicol Eye Drops look like and contents of the pack

Chloramphenicol Eye Drops are supplied in plastic bottles, each bottle containing 10ml of sterile solution.

Marketing Authorisation Holder:

Martindale Pharmaceuticals Ltd.

Bampton Road, Romford, RM3 8UG, England Manufacturer:

FAMAR S.A 63.Ag Dimitriou str.

17456 Alimos, Athens 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.

Product Licence Numbers: PL 00156/0048 HK - 09064

This leaflet was last updated May 2011


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Description: PIL CHLORAMPHENICOL EYE DROP 0.5%_

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