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In this leaflet:

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

2.    Before you use Chloramphenicol Ear Drops

3.    How to use Chloramphenicol Ear Drops

4.    Possible side effects

5.    Storing Chloramphenicol Ear 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 Ear 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 Ear Drops are used in the treatment of a wide range of bacterial infections of the outer ear.

2.    Before you use Chloramphenicol Ear Drops

Do not use Chloramphenicol Ear Drops if:

•    you are allergic (hypersensitive) to Chloramphenicol, Propylene Glycol or to any of the other ingredients in this medicine (see section 6)

•    you have a hole in your ear drum.

Take special care with Chloramphenicol Ear Drops

Tell your doctor if :

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

Taking other medicines

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

Pregnancy and breast-feeding Chloramphenicol Ear Drops should not oe used if you are pregnant, trying to become pregnant or are breast-feeding, unless your doctor has specifically recommended it.

Driving and using machines

It is unlikely that after using Chloramphenicol Ear Drops your ability to drive and use machines will be affected. However, if you feel unwell you must speak to your doctor before driving or operating machinery.

3. How to use

Chloramphenicol Ear Drops

Always read the leaflet before beginning treatment.

Instructions for use

1.    Wash your hands well before use

2.    Remove the outer cap on the bottle

3.    Insert the nozzle into the affected ear and apply drops as advised by your doctor

4.    Repeat in the other ear if you have been told to use Chloramphenicol Ear Drops in both ears

5.    Replace the outer cap on the bottle, trying not to touch the applicator tip with anything, including the fingers

6.    Wash your hands.

How much to use

Three to four drops should be applied into the affected ear up to two to three times daily for up to one week.

Do not use Chloramphenicol Ear Drops for more than a one week period unless your doctor has told you otherwise.

Always use Chloramphenicol Ear Drops exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

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

Continued overleaf

4.    Possible side effects

_ike all medicines Chloramphenicol Ear Drops can cause side effects, although not everyone gets them.

Possible side effects include: mild stinging irritation burning itching

inflammation of the skin (dermatitis).

Rare side effects include:

•    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.

ong term use of this product can stop it having any effect.

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

5.    Storing Chloramphenicol Ear Drops

Keep out of the reach and sight of children.

Do not use Chloramphenicol Ear Drops after the expiry date printed on the bottle label. The expiry date refers to the ast day of that month.

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

Once you have opened the bottle it should not be used after four weeks.

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 Ear Drops contain

The active ingredient is Chloramphenicol 5% w/v BP.

The other ingredient is Propylene Glycol 95%).

What Chloramphenicol Ear Drops look like and content of the pack

hloramphenicol Ear Drops are supplied in plastic bottles, each bottle ontaining 10ml of solution.

Marketing Authorisation Holder and Manufacturer

Martindale Pharmaceuticals Ltd. Bampton Road,

Romford, RM3 8UG, England 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 00156/0050

Date of last revision: November 2015

Martindale

Pharmaceuticals

M

Bampton Road, Harold Hill Romford, RM3 8UG United Kingdom

D0305100000

3051 -C

100mm Measurement Verification Bar

Component Code: D03051

Prod: CHLORAMPHENICOL EAR

DROPS 5% 10ML

Trim size: 120 x 240 mm