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

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This leaflet was last approved in:

20 April 2016