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TUBILUX INFECTED EYES EYE DROPS

Active substance(s): CHLORAMPHENICOL

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TUBILUX INFECTED EYES
EYE DROPS
CHLORAMPHENICOL 0.5% w/v
Read all of this leaflet carefully before you start taking 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, please 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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet
1. What Tubilux Infected Eyes Eye Drops are and what it is used for
2. What you need to know 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. Contents of the pack and other information

1. What Tubilux Infected Eyes Eye Drops are and what it is 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.

2. What you need to know before you use Tubilux Infected Eyes Eye Drops
If you have severe eye pain or disturbed vision, consult your doctor immediately.
Do not use the eye drops if:
• you are allergic to chloramphenicol or any of the other ingredients of this medicine (listed in
section 6). 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 your blood (in particular very low numbers of blood cells) after
taking chloramphenicol.
• you, or anyone in your family, have had blood or bone marrow problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tubilux Infected Eyes Eye Drops.
Take special care with Tubilux Infected Eyes 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

Tell your doctor or pharmacist if you are using, have recently used or
might use any other medicines, including medicines obtained without a
prescription.
Pregnancy and, breast-feeding and fertility
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, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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
Always use this medicine exactly as recommended. Check with your doctor or pharmacist if you
are not sure.
The recommended dose is:
Use in adults and children
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.
Use in newborn infants
Your child's doctor may prescribe the lower dose to reduce the risk of side effects. The
maximum duration of treatment is 10-14 days.
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.
If you use more Chloramphenicol 1% w/w Eye Ointment than you should
There is no experience of an overdosage with Tubilux Infected Eyes Eye Drops which is unlikely
when given as eye drops.
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.
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. Do not take a double dose to make up for a forgotten
dose.
If you stop using Tubilux Infected Eyes Eye Drops
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Tubilux Infected Eyes 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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system listed.

United Kingdom
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.
5. How to store Tubilux Infected Eyes Eye Drops
Keep this medicine out of the sight and reach 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. The expiry date refers to the last day of that month.

Any drops remaining after the 5-day course of treatment should be discarded.
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. Contents of the pack and other 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
KT2 6TN
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:
20 April 2016

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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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