MINIMS CHLORAMPHENICOL 0.5%

Active substance: CHLORAMPHENICOL

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Minims® Chloramphenicol 0.5% w/v
Eye Drops, solution
Chloramphenicol

Read all this leaflet carefully before you start using your
medicine. It contains a summary of the information available on
your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone
else.
In this leaflet:
1. What Minims® Chloramphenicol eye drops are and what they
are used for
2. Before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Further information

1. What Minims® Chloramphenicol eye drops are and
what they are used for
Minims® Chloramphenicol contains an antibiotic. It is used to
treat infections of your eyes.
Sometimes parts of the outer surface of the eye, such as the
cornea (the transparent membrane covering the surface of the
eye) or the conjunctiva (the lining of the inside of the eyelids
and part of the eye), may become infected with bacteria. These
eye drops can be used to treat this infection and are effective
against many different types of bacteria.
If the eye infection is very severe, your doctor may give you
antibiotic tablets as well as these antibiotic eye drops.
This medicine is indicated for children, adults and the elderly.

2. Before you use your eye drops
Do not use these drops if
you are allergic to the active substance (chloramphenicol) or
any of the ingredients (refer to the end of this leaflet).
Take special care
If you use these eye drops over a long period of time they could
possibly become less effective or produce allergic reactions. In
order to prevent this, make sure that you stop using this
medicine as soon as your doctor tells you to.
Do you use any of these medicines?
Chymotrypsin (solution used during cataract surgery) may not
work properly when used at the same time as Minims®
Chloramphenicol.
If you are pregnant, may be pregnant, or are breastfeeding
Tell your doctor or eye specialist, he/she may decide to use
these drops or to prescribe you an alternative.
Contact lenses
Your doctor will ask you to remove your contact lenses prior to
the administration of the drops.
Do not wear your contact lenses throughout the entire treatment
course.
Driving and using machines
As with all eye drops, your vision may be blurred after putting
the drops in. Wait until your vision is clear before driving or
using machines.

3. How to use your eye drops
Do not use this product for longer than the time frame
stated by your doctor or eye specialist, as it may become
less effective at treating your eye infection.
The drops are in special single use “Minims” units, to treat both
eyes if both eyes are infected. Once opened, use immediately.
Discard any unused portion.
Dosage
The normal dose is 1 to 2 drops to each infected eye up to six
times a day.
If you have a severe infection your doctor or eye specialist may
ask you to use this medicine more frequently at first, until the
infection starts to get better. The frequency of treatment can
then be gradually reduced.
If your eyes get worse or are not better after a few days of
using these eye drops, see your doctor or eye specialist or
pharmacist.

Method of administration
Make sure you follow these instructions carefully:
1. Wash your hands.
2. Use a mirror, this will help you to see what you are doing.
3. Carefully dry your eyes using a tissue, and twist off the cap
from the Minims body of the unit.
4. Pull your lower eyelid down gently, and then carefully place 1
or 2 drops inside your lower eyelid.
Make sure the dropper does not touch any parts of your eye.
5. Close your eye and blink a few times to make sure your eye
is covered by the liquid.
6. Close the eyelids. It is advisable to press gently on the inner
corner of your eyelid for 3 minutes. This will help stop the
solution draining into your nose and throat. This is especially
advisable in children, the elderly and population at risk.
7. Repeat steps 4, 5 and 6 for the other eye if necessary, then
throw away the Minims unit, even if some solution remains.
If you use more Minims® Chloramphenicol than you should,
an overdose is very unlikely to occur. If you suddenly feel unwell
after receiving the drops, tell your doctor or eye specialist or
contact your nearest emergency department immediately.
If you forget to use Minims® Chloramphenicol, you should take
the missed dose as soon as you remember, unless it is nearly time
for the next dose, but you should not take a double dose to make up
for a missed dose.

4. Possible side effects
Minims® Chloramphenicol may cause burning, stinging,
itching and skin irritation (including dermatitis) around the
area it has been used on. These effects are not
permanent.
Aplastic anaemia (condition in which the bone marrow is
unable to produce blood cells) and bone marrow
depression can occur but these are extremely rare and
your doctor will have taken your medical history into
account when deciding to prescribe Minims®
Chloramphenicol. Pale skin, weakness, increased heart
rate, out of breath, headache, pain, fever, infection,
bruises may be a sign a severe blood disorder.
If any of the side effects gets serious, please seek immediate
medical attention. If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. How to store your eye drops
Keep out of the reach and sight of children.
Do not use the eye drops after the expiry date which is stated
on the overwrap of each unit and on the carton after the letters
“EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Store in the
original package in order to protect from light.
If necessary, the product may be stored at temperature not
exceeding 25°C for up to 1 month only and then thrown away.
In that case, affix a label bearing the relevant expiry date to the
carton label.
The drops are in special single use “Minims” units, to treat both
eyes if both eyes are infected. Once opened, use immediately.
Discard any unused portion.
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 do your eye drops contain
The active ingredient is chloramphenicol. Each Minims
unit contains approximately 0.5 ml eye drops solution of
chloramphenicol 0.5% w/v (2.5 mg).
The other ingredients are borax, boric acid and purified
water.
This medicine does not contain a preservative as it is a sterile
single use unit.
Contents of the pack
Each carton contains 20 units.
Marketing Authorisation Holder:
Chauvin Pharmaceuticals Ltd.
106 London Road - Kingston-upon-Thames - KT2 6TN - UK
Tel: +44 (0)20 8781 2900 / Fax: +44 (0)20 8781 2901
Manufacturer:
Laboratoire Chauvin - Z.I.Ripotier - 07200 Aubenas - France
Marketing Authorisation Numbers:
Minims® Chloramphenicol 0.5% w/v :
PL 0033/0055R (UK) ; PA118/19/1 (Ireland)
DATE OF PREPARATION: November 2008
Art.76553 GB239E01-05.07

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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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