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Optrex Infected Eye Ointment

Document: leaflet MAH BRAND_PL 00062-0052 change

INFECTED EYE OINTMENT

Chloramphenicol


Hease read all of this leaflet carefully before you start using ^our eye ointment. Keep this leaflet. You may need to read it again.

Remember-this medicine is for you. Never give it to other people - it may harm them, even if their symptoms appear to be the same.

I

1. What is your medicine for?

Optrex Infected eye Ointment is a topical ointment for administration to the eye only. It contains an antibiotic called chloramphenicol and is used to treat bacterial infections that Effect the outer surface of the eye.

Irhe most common type of infection in this area is called acute {bacterial conjunctivitis. When you have acute bacterial [conjunctivitis the white part of one or both of your eyes will be red and /or your eyelids will be red or swollen. There will be a sticky discharge, which can make the eye difficult to open in {he morning and the eye may feel ‘gritty’ or ‘irritated’. Chloramphenicol eye ointment is not suitable for treating eye Infections that have spread to the deeper layers of the eye [coverings or into the fluid within the eyeball. Antibiotic tablets br injections are needed to treat these deeper and more serious infections.

i. Before using your medicine

Optrex Infected Eye Ointment is recommended for children juver 2 years, adults and the elderly.

|t is recommended that any child below the age of two years with an eye infection should be seen by a doctor.

Do not use this product if you t are allergic to chloramphenicol or any of the ingredients ^hown under section 6 “What is in the pack”

* have ever had problems with your blood On particular with low numbers of cells) during previous treatments with chloramphenicol

k have a family history of blood problems such as low white [blood cell, red blood cell or platelet count.


Do not use this product and seek advice from a doctor if

•    your eyesight is affected Goss of sight, reduced vision, blurred vision or halos around lights)

•    you have pain within the eye

•    your eye has suffered a blow or other injury

•    your eye is inflamed and you have a rash on the scalp or face

•    the pupil of your eye looks unusual or your eye looks cloudy

•    your eyes are sensitive to light

•    you have (or think you have) a foreign body in your eye, which has not been removed

•    you have recently had an eye infection

•    you suffer from or have ever suffered from glaucoma or dry eye syndrome

•    you wear contact lenses. If you wear contact lenses and your contact lens practitioner or doctor has advised you to use this product, do not wear your lenses during the course of treatment. Soft contact lenses should not be replaced for 24 hours after completing the treatment.

•    you are using any other eye drops or eye ointment

•    you have had eye suigery or laser treatment in the last months.


Tell your pharmacist before using this product if you

•    suffer from any other eye problems.

•    are taking any other medicines


If you are taking other medicines:

If you are taking bone marrow depressant drugs (drugs which decrease the activity of the bone marrow, causing low blood cell counts) such as azathioprine or receiving chemotherapy, seek the advice of your pharmacist or your doctor before using this product.


Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant or breastfeeding tell your doctor or pharmacist before using this product.


Driving and operating machinery

After using the eye ointment, you may temporarily get blurred vision. Do not drive or operate machinery until your vision is clear. If in doubt, talk to your pharmacist or doctor.


Please turn over


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"II Row to use tHis product?


PossMe side effects


Applying the ointment

[To be used in the eye(s) only.

i 1. Check the tube seal is not broken before first using the eye !    ointment.

| 2. Wash and dry your hands 1 3. Remove the cap. Take special care that the nozzle of the i tube does not touch your eye, the skin around your eye or !    your fingers.

| 4. Use a mirror, this will help you see what you are doing 1 5. Place the nozzle    of the tube close    to your eye. Gently pull

i    the lower eyelid    downwards and    look up.

i 6. Squeeze the tube gently and apply about 1 cm of the ]    ointment to the space between the lower eyelid and the eye.

| 7. Close for a moment

i 8. When both eyes are to be treated, repeat steps 5-7. i 9. Replace the cap securely after use.


\


[Whilst applying the ointment, do not [• Breathe on or touch the nozzle of the tube '• Touch the eyes or eyelids with the nozzle of the tube i* Share your ointment with anyone else

I

For external use only

1

---i iDose


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'The dose is a small amount of ointment (approx 1 cm) to be iapplied to the affected eye(s)

[If you are using drops during the day and the ointment at night -[apply the ointment at night, before going to bed.

'If you are using just the ointment - apply 3 to 4 times a day. iLength of treatment

[The course of treatment is 5 days. Keep using the eye ointment [for5 days, do not stop just because you feel better - this could 'make your condition worse.

ilf your symptoms do not improve within 48 houis, consult your [doctor. If your symptoms get worse, seek medical advice at once. [Do not use Optrex Infected Eye Ointment for more than 5 days 'without consulting your doctor. Discard any remaining ointment 'after the 5 day course of treatment.


If you forget to use your ointment

If you have only just missed a dose and it is a long time before the next dose is due, put in the missed dose straight away. If you have missed the dose some time ago and it is nearly time for your next dose, just put in the next dose of ointment at the right time. Never double up on a next dose to make up for the one you have missed.


Some people may get one or more of these side effects. Some effects happen straight away but do not last long - others may only happen after several days of use.

Possible side effects include:

•    allergic reactions such as itching or rashes. If you get a severe reaction, with swelling or breathing problems get medical help straight away.

•    changes in the blood (anaemia) leading to severe tiredness or easy bruising.

Stop using the treatment and consult your doctor if you experience these effects.

•    The use of topical chloramphenicol may

occasionally result in the overgrowth of other non susceptible organisms including funghi. If any new infection appears during treatment you should tell your doctor.

•    blurred vision or mild burning or stinging when you put the ointment in. These should subside quickly.

If you do not feel well or are worried about your health, talk to a pharmacist or doctor.

If any of the side effects get serious or if you experience any side affect not listed in this leaflet please tell your doctor or pharmacist.

5.    Storing your medicine

Replace the cap securely after use. Store below 25°C.

Keep all medicines out of the sight and reach of children. Do not use after the ‘use by* date shown on the tube and end of the carton.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment. The content of the tube must be used within 28 days after opening. After 28 days, any remaining product must be discarded.

6.    What is in the pack?

Each pack contains 4g of the ointment. The ointment contains 1 %w/w chloramphenicol, which is equivalent to 10mg of chloramphenicol per 1 gram of ointment. Also contains liquid paraffin and polyethylene in mineral oil.

Further information

If you have any questions or are not sure about anything, ask your pharmacist or doctor. They can obtain more information about this medicine if needed.

Licence holder: Optrex Limited, Hull, HU8 7DS, UK.

Manufacturer: Patheon UK Limited

Swindon

SN35BZ

UK

PL00062/0052.

CM

Leaflet revised April 2010.    §