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CHLORAMPHENICOL EAR DROPS BP 10%

Active substance(s): CHLORAMPHENICOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Chloramphenicol Ear Drops 10% w/v BP
Chloramphenicol

D03052

Read all of this leaflet carefully before you use Chloramphenicol Ear Drops.
• Keep this leaflet. You may need to read it again.
• If you have any further question please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should 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 get 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 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
be used if you are pregnant, trying to
become pregnant or are breast-feeding,
unless your doctor has specifically
recommended it.

4. Possible side effects

6. Further Information

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

What Chloramphenicol Ear Drops
contain
The active ingredient is
Chloramphenicol 10% w/v BP.
The other ingredient is Propylene Glycol
(90%).
What Chloramphenicol Ear Drops
look like and content of the pack
Chloramphenicol Ear Drops are
supplied in plastic bottles, each bottle
containing 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.

Possible side effects include:
• mild stinging
• irritation
• burning
• itching
• inflammation of the skin (dermatitis).

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.

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.

3. How to use
Chloramphenicol Ear Drops

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

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.

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

Product Licence Numbers:
PL 00156/0051
Date of last revision: November 2015

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
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
last day of that month.
This medicine needs to be stored upright
between 2-8°C (in a refrigerator). Protect
from 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.

Continued overleaf
D03052

3052 -C

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
Component Code: D03052
Prod: CHLORAMPHENICOL EAR
DROPS 10% 10ML
Trim size: 120 x 240 mm
Version Control Date

By

Version A Created 08/07/15 AC
Version B

15/07/15 AC

Version C

04/11/15 AC

Version D
Version E
Version F
Version G
Version H
Version I
Version J
Version K
Version L
Version M
Version N
Grand Fromage Creative Limited
1 Blighs Road, Sevenoaks,
Kent, TN13 1DA, UK
t: 01732749 749
e: alan@grand-fromage.co.uk
www.grand-fromage.co.uk

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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