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EYKAPPO 5 MG/ML EYE DROPS SOLUTION

Active substance(s): CHLORAMPHENICOL / CHLORAMPHENICOL

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Package leaflet:
Information for the user

To avoid possible contamination of
the multi-dose container, keep the tip
of the multi-dose container away
from contact with any surface.
Instructions for use

5mg/ml
eye drops, solution
Chloramphenicol
Read all of this leaflet carefully
before you start using this
medicine because it contains
important information for you.
- Keep this leaflet. You may need to
read it again.
- If you have any further questions,
ask your doctor or pharmacist.
- This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same
as yours.
- If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Eykappo is and what it is
used for
2. What you need to know before you
use Eykappo
3. How to use Eykappo
4. Possible side effects
5. How to store Eykappo
6. Contents of the pack and other
information

Before instillation of the eye
drops:
- Wash your hands before opening
the bottle.
- Do not use this medicine if you
notice that the tamper-proof seal
on the bottle neck is broken before
you first use it.
- When using for the first time,
before delivering a drop to the eye,
you should first of all practice using
the dropper bottle by squeezing it
slowly to deliver one drop into the
air, away from the eye.
- When you are confident that you
can deliver one drop at a time,
choose the position that you find
most comfortable for the instillation
of the drops (you can sit down, lie
on your back, or stand in front of
a mirror).
Instillation:
1. Hold the bottle directly below the
cap and turn the cap to open the
bottle. Do not touch anything with
the tip of the bottle to avoid
contamination of the solution.

2. Tilt your head backwards and hold
the bottle above your eye.
3. Pull the lower eyelid down and
look up. Squeeze the bottle gently
in the middle and let a drop fall
into your eye. Please note that
there might be a few seconds
delay between squeezing and the
drop coming out. Do not squeeze
too hard.
If you are not sure how to
administer your medicine, ask your
doctor, pharmacist or nurse.

1. What Eykappo is and
what it is used for

Eykappo contains a medicine called
chloramphenicol. This belongs to a
group of medicines called antibiotics.
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 this antibiotic
eye drops.
4. Blink a few times so that the
This medicine is indicated for children,
drop spreads over the eye.
adults and the elderly.
Eykappo eye drops solution is a
sterile solution that does not contain
a preservative.

2. What you need to know
before you use Eykappo
Do not use Eykappo if
• you are allergic to chloramphenicol
or any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist
before using Eykappo.
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.
Children and adolescents
Eykappo can be used in children and
adolescents.
Other medicines and Eykappo
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant, may be pregnant
or are breast-feeding, tell your doctor
or eye specialist. He/she may decide
to use these drops or to prescribe you
an alternative.
The drops should not be used during
pregnancy and breast-feeding unless
considered essential by your doctor.
Contact lenses
Contact lenses should not be worn in
an infected eye. 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 Eykappo
Always use this medicine exactly as
your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.
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.
Dose
The recommended dose is 1 to 2
drops to each infected eye up to six
times a day. You should continue
your treatment for 2 days after
symptoms disappear, to prevent the
recurrence of infection. The maximum
recommended duration of treatment
is 14 days.
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.
Use in children
It may be necessary to adjust the
dose for newborn infants as, due to
their immature metabolism they may
be at risk of dose-related adverse
effects.
The maximum duration of treatment
is 10-14 days.
Do not allow the tip of the multi dose
container to touch the eye or areas
around the eye. It could cause injury
to your eye. The eye drops solution
may become contaminated with
bacteria that can cause eye infections
leading to serious damage of the eye,
even loss of vision.

5. After using Eykappo, press a finger
into the corner of your eye, by the
nose for 2 minutes. This helps to
stop the solution getting into the
rest of your body.

6. Repeat the instructions 2 – 5 to
deliver a drop into the other eye
also, if your doctor has instructed
you to do this. Sometimes only one
eye needs to be treated and your
doctor will advise if this applies to
you and which eye needs
treatment.
7. After each use and prior to
recapping, the bottle should be
shaken once in a downwards
direction, without touching the
dropper tip, in order to remove any
residual liquid on the tip. This is
necessary in order to ensure
delivery of subsequent drops.

8. After you have used all doses
there will be some Eykappo left in
the bottle. You should not be
concerned since an extra amount of
Eykappo has been added and you will
get the full amount of Eykappo that
your doctor has prescribed. Do not
attempt to use the excess medicine
remaining in the bottle after you
have completed the course of
treatment. Do not use the eye drops
for longer than 28 days after first
opening the bottle.
If you use more Eykappo 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 Eykappo
If you forget a dose, use your drops
as soon as you remember and then
go on as before.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
• Eykappo may cause burning,
stinging, itching and skin irritation
(including dermatitis) around the
area it has been used on. These
effects are not permanent.
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. You
can also report side effects directly
via the Yellow Card Scheme (website:
www.mhra.gov.uk/yellowcard). By
reporting side effects you can help
provide more information on the
safety of this medicine.

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5. How to store Eykappo
Keep this medicine out of the sight
and reach of children.
Do not use this medicine after the
expiry date which is stated on the
bottle and on the carton after ‘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.
After first opening, the product may
be stored for a maximum of 28 days.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect
the environment.

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Aspire Pharma Ltd,
Unit 4, Rotherbrook Court
Bedford Road, Petersfield
Hampshire, GU32 3QG
United Kingdom.
Manufacturer
Pharmathen S.A.,
6 Dervenakion
15351 Pallini Attiki
Greece
and
EXCEL VISION
27 st. La Lombardière,
Zl La Lombardière,
ANNONAY 07100
France

6. Contents of the pack and
other information

This leaflet was last revised in
02/2017

What Eykappo contains
• The active ingredient is
chloramphenicol. Each multi-dose
container contains approximately
10ml eye drops solution of
chloramphenicol 5mg/ml.
• The other ingredients are borax,
boric acid, sodium hydroxide or/
and hydrochloric acid (for pH
adjustment) and water for
injections.
What Eykappo looks like and
contents of the pack
10ml of Eykappo eye drops solution is
filled in an 11 mL LDPE white opaque
ophthalmic dropper container packed
in a cardboard box.
Each carton contains 1 multi-dose
container.

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Aspire Pharma Limited
Eykappo 5mg/ml
PL 35533/0123
Leaflet
630mm x 120mm
Yes
10 January 2017
Text edits
1.3
2 February 2017
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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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