Package leaflet: Information for the user Chlormytol 1%w/w Eye Ointment

Chloramphenicol

The product is known by the name above but will be referred to as Chlormytol Ointment throughout the rest of this leaflet.

What is in this leaflet

1.    What Chlormytol Ointment is and what it is used for

2.    What you need to know before you use Chlormytol Ointment

3.    How to use Chlormytol Ointment

4.    Possible side effects

5.    How to store Chlormytol Ointment

6.    Contents of the pack and other information

1.    What Chlormytol Ointment is and what they it is used for

Chlormytol Ointment is a topical ointment for administration to the eye only, it contains an antibiotic called chloramphenicol. When chloramphenicol is given in eye ointment, it is used to treat bacterial infections that affect the outer surfaces of the eye.

The 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 the morning and the eye may feel ‘gritty’ or ‘irritated’.

Chlormytol Ointment can be used in adults and children. 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 or injections are needed to treat these deeper and more serious infections.

You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

2.    What you need to know before you use Chlormytol Ointment

Chlormytol Eye Ointment is recommended for children, adults and the elderly.

Do not use Chlormytol Ointment if you:

• are allergic to chloramphenicol or any of the other ingredients of this medicine (listed under section 6)

•    have ever had problems with your blood (in particular with low numbers of cells) during previous treatments with chloramphenicol

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

Warnings and precautions

Talk to your doctor or pharmacist before using Chlormytol Ointment if:

•    your eyesight is affected (loss 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 surgery or laser treatment in the last 6 months.

•    are taking any other medicines

•    suffer from any other eye problems.

Other medicines and Chlormytol Ointment:

Talk to your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking medicines which lower your immune system such as azathioprine or receiving chemotherapy, seek the advice of your pharmacist or your doctor before using this product.

Pregnancy, breastfeeding and fertility

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 using this medicine.

Driving and using machines

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.

3. How to use Chlormytol Ointment

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Applying the ointment:

To be used in the eye(s) only.

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

2.    Wash and dry your hands.

3.    Remove the cap. Take special care that the nozzle of the 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.

5.    Place the nozzle of the tube close to your eye. Gently pull the lower eyelid downwards and look up.

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

7.    Close for a moment.

8.    When both eyes are to be treated, repeat steps 5-7.

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

•    Share your ointment with anyone else.

For external use only Dose:

The recommended dose is a small amount of ointment (approx 1cm) to be applied 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.

Length of treatment:

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

If your symptoms do not improve within 48 hours, consult your doctor. If your symptoms get worse, seek medical advice at once.

Do not use Chlormytol Ointment for more than 5 days without consulting your doctor.

Discard any remaining ointment after the 5 day course of treatment.

Paediatric population

Dosage adjustment may be necessary in newborn infants because of reduced systemic elimination due to immature metabolism and the risk of dose-related adverse effects. The maximum duration of treatment is 10-14 days.

If you use more Chlormytol Ointment than you should

If you accidently apply too much ointment, you should wash your eye with plenty of water for at least 15 minutes. If any painful symptoms continue after this, you should tell your doctor immediately.

If you forget to use Chlormytol 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. Do not apply a double dose to make up for a forgotten dose.

If you stop using Chlormytol Ointment

If you stop treatment with Chloramphenicol Ointment before completing treatment your eye infection may not completely clear. Speak to your doctor or pharmacist before stopping Chloramphenicol Ointment.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

Stop using this treatment and consult your doctor if you experience these effects:

•    allergic effects such as itching, or rashes (get medical help straight away if you get a severe reaction with swelling or breathing problems)

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

•    the use of topical chloramphenicol may occasionally result in the overgrowth of other non susceptible organisms including fungi. If any new infection appears during treatment you should tell your doctor

Other side effects:

Not known (frequency cannot be estimated from available data)

•    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.

•    Fever

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Medicines and Healthcare Products Regulatory Agency yellow card scheme: www.mhra.gov.uk/yellowcard.

By reporting side effects you help to provide more information about the safety of this medicine.

5.    How to store Chlormytol Ointment

Replace the cap securely after use. Do not store above 25°C.

Keep this medicine out of the sight and reach of children. If your doctor tells you to stop treatment, return any leftover ointment to your pharmacist. Do not use this medicine after the ‘use by’ date which is stated on the tube and carton. The use by date refers to the last day of that month.

Do not throw any medicine via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. The contents of the tube must be used within 28 days after opening. After 28 days any remaining product must be discarded.

6. Contents of the pack and other information What Chlormytol Ointment contains

-    The active substance is chloramphenicol.

The ointment contains 1%w/w chloramphenicol, which is equivalent to 10mg of chloramphenicol per 1 gram of ointment.

-    The other ingredients are liquid paraffin and polyethylene in mineral oil.

What Chlormytol Ointment looks like and contents of the pack

Chlormytol Ointment is a smooth uniform translucent greasy ointment. Chlormytol Ointment is supplied in a polyethylene tube laminated with aluminium and fitted with a white polyethylene nozzle and screw cap containing 4g of ointment.

Product Licence Holder:

Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Manufacturer: Patheon UK Limited, Kingfisher Drive, Covingham, Swindon, Wiltshire SN3 5BZ, UK.

PL 12762/0400

This leaflet was last revised in April 2016.