TUBILUX INFECTED EYES EYE DROPS

Active substance: CHLORAMPHENICOL

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FPO

TUBILUX INFECTED EYES
EYE DROPS
Chloramphenicol 0.5% w/v

Please read this leaflet carefully
before you start to take your
medicine.
• 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. 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 gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Tubilux Infected Eyes Eye
Drops are and what they are
used for
2. Before you use Tubilux Infected
Eyes Eye Drops
3. How to use Tubilux Infected Eyes
Eye Drops
4. Possible side effects
5. How to store Tubilux Infected
Eyes Eye Drops
6. Further information

1. What Tubilux Infected Eyes
Eye Drops are and what they
are used for
The name of this medicine is Tubilux
Infected Eyes Eye Drops, which is
referred to as “eye drops” throughout
this leaflet.
Eye drops is used to treat acute
bacterial conjunctivitis, which is an
infection of the outer surfaces of the eye.
Recognizing acute bacterial
conjunctivitis
The symptoms of bacterial
conjunctivitis are:
• Eyes look swollen and red or pink
• Discharge from the eye
• Irritation or gritty feeling in the eye
Your doctor or pharmacist can provide
further advice about these symptoms.
The active ingredient of the eye drops
is chloramphenicol, which is an antibiotic.
The eye drops are recommended for
use in adults and in children aged 2
years and above.

777063UKOTC/2X
9180800

• you, or anyone in your family, have
had blood or bone marrow problems.
Take special care with the eye drops
if you:
• wear contact lenses
• have had eye surgery within the last
6 months.
• are already using other eye drops or
eye ointments
• have an eye injury
• are pregnant or breast feeding
• have glaucoma
• have dry eye syndrome
• have recently had an eye infection
• have disturbed vision
• are sensitive to light
• have severe pain inside the eye
• have cloudy eye,
• have eye inflammation accompanied
by a rash on the scalp or face
• have, or think you have, a suspected
foreign body in the eye
Taking other medicines
Please tell your doctor or pharmacist
if you are applying any other type of
eye drops or eye ointment before you
start to use this medicine.
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription.
Pregnancy and breast-feeding
The eye drops should not be used by
pregnant women or women who are
breast-feeding unless absolutely
necessary. If you are pregnant or
breast-feeding you should discuss this
with your doctor before you start to
apply the drops.
Driving and using machines
Do not drive or operate machines if
you have blurred vision after using the
eye drops. You should wait until this
clears before driving or using
machines.
Important information about some
ingredients of the eye drops
The product contains phenylmercuric
nitrate as preservative which may
cause allergic reactions.

3. How to use Tubilux Infected
Eyes Eye Drops

2. Before you use Tubilux
Infected Eyes Eye Drops

Always use eye drops exactly as
recommended. You should check with
your doctor or pharmacist if you are
not sure.

If you have severe eye pain or
disturbed vision, consult your
doctor immediately.
Do not use the eye drops if:
• you have had an allergic reaction or
been told that you are allergic to
chloramphenicol or to any of the
other ingredients in this medicine.
Remember that chloramphenicol
can also be given by mouth or by
injection so you should mention any
allergic reaction that you think you
may have had to chloramphenicol to
your doctor or pharmacist.
• you have had problems with yourblood
(in particular very low numbers of blood
cells) after taking chloramphenicol.

The recommended dose is one drop
in the affected eye(s) every 2 hours
for the first 48 hours and every four
hours thereafter. The drops should be
used during waking hours. The course
of treatment is five days. You should
complete the whole course. Do not
use the drops for more than 5 days
without consulting your doctor.

If your eye has not improved within
48 hours or if you still have some
symptoms after 5 days, you should
tell your doctor because you may
need another type of treatment.
If your eye seems to get worse during
treatment, you should tell your doctor
immediately.
Always wash your hands before
applying eye drops.
Apply your eye drops in the
following way:
1.Open the bottle. Take special care
that the tip of the dropper bottle
does not touch your eye, the skin
around your eye or your fingers.
2.Tilt your head backwards while
seated, or lie down on your back.
3.Place the tip of the bottle close to
your eye. Pull the lower eyelid
downwards and look up.
4.Press the bottle slightly and let one
drop fall into the space between the
lower eyelid and the eye.
5.Close your eye for a moment.
6.When both eyes are to be treated,
repeat steps 3 to 6 for the other eye.
7.Replace the cap securely after use.
Overdose
There is no experience of an
overdosage with Tubilux Infected
Eyes Eye Drops which is unlikely
when given as eye drops.

Tell your doctor immediately, if you:
• notice that you are feeling generally
weak and tired, or
• get another infection or
• notice easy bleeding or bruising
during or shortly after using the drops
Other local side effects:
• burning or stinging in and around
the eye.
If you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

5. How to store Tubilux
Infected Eyes Eye Drops
Keep out of the reach and sight of
children.
Store in a refrigerator between 2-8°C
in the original carton to protect the
solution from light. DO NOT FREEZE.
Keep the container tightly closed.
Discard the bottle 28 days after
opening, even if there is solution
remaining.
Do not use the eye drops after the expiry
date which is stated on the bottle and
on the carton the bottle is packed in.

If you swallow the eye drops by
accident
The amount of chloramphenicol in a
bottle is small and unlikely to cause
side effects. However, if you are
concerned, tell your doctor or
pharmacist who will advise you on
any necessary measures.

Any drops remaining after the 5-day
course of treatment should be
discarded.

If you forget to use the eye drops
If you forget to use the eye drops on
time, put in the next dose as soon as
you remember, unless it is nearly time
for your next dose.

4. Possible side effects
Like all medicines, the eye drops can
cause side effects, although not
everybody gets them.
Most of these side effects affect only
the eye and may not last very long. If
you have any severe or persistent side
effect you should stop using the drops
and contact your doctor immediately.
If you notice any of the following side
effects, you must stop using the
drops and contact your doctor or
the nearest hospital emergency
department immediately:
Very severe side effects:
• swelling of the face and neck,
• difficulty in breathing,
• a drop in blood pressure and
unconsciousness,
• high temperature,
• rashes that may be red and raised
and may blister.
Less severe side effects:
• allergic reactions that affect only the
eyes and can cause redness and
itching, with swelling of the eyelids.
When chloramphenicol is given by
mouth or by injection, it may cause
drops in the numbers of all types of
blood cells leading to anaemia,
infections and easy bruising and
bleeding. Very occasionally, these
effects cannot be reversed and have
been fatal. Although only very small
amounts of chloramphenicol are

absorbed from the eye drops into your
bloodstream, there have been reports of
these severe effects even with eye
drops.

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 the eye drops contain
The active ingredient is
chloramphenicol. The eye drops
solution contains 0.5%
chloramphenicol which is equivalent
to 5 mg of chloramphenicol per ml.
This product also contains
phenylmercuric nitrate, borax, and
boric acid as excipients.
What the eye drops look like and
contents of the pack
One bottle of Tubilux Infected Eyes
Eye Drops contains 10 ml solution
with chloramphenicol as the active
ingredient.
Marketing Authorisation Holder
Bausch & Lomb (UK) Ltd.
106 London Road
Kingston-Upon-Thames
Surrey
UK
Manufacturer
TUBILUX PHARMA S.p.A.
Via Costarica 20/22
00040 Pomezia (RM)
ITALY
PL number 03468/0025
Hard to see or read the leaflet?
Call +01748 828864 for help.
This leaflet was last approved in:
08/2010

777063UKOTC/2X
9180800

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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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