Package leaflet: Information for the user Chloromytol® 0.5% w/v Eye Drops

Chloramphenicol

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

What is in this leaflet

1.    What Chloromytol Eye Drops is and what it is used for

2.    What you need to know before you use Chloromytol Eye Drops

3.    How to use Chloromytol Eye Drops

4.    Possible side effects

5.    How to store Chloromytol Eye Drops

6.    Contents of the pack and other information

1. What Chloromytol Eye Drops is and what it is used for

It is used to kill bacteria that cause infections of the surface of the eye. If your eye is infected it will probably be red and feel gritty. You may experience a sticky discharge from the eye. The infection and its effect on your eye is called bacterial conjunctivitis.

The medicine can be used to treat adults and children.

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 Chloromytol Eye Drops Do not use Chloromytol Eye Drops if:

•    you have experienced problems involving your blood cells when using chloramphenicol in the past

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

•    you or someone in your family has ever had a blood disease or bone marrow problems. Signs of this include tiredness, unusual bruising or an increase in the number of infections that you get

•    the tamper evident seal on the bottle cap had been broken before your use.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Chloromytol Eye Drops if:

•    you have a foreign body (e.g. splinter or grit) in your eye or, it is physically injured

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

•    you are sensitive to light or feel pain within your eyeball

•    you cannot see properly (reduced or blurred vision)

•    the black or coloured parts of your eye look cloudy or unusual.

•    you wear contact lenses. If your doctor, contact lens practitioner or pharmacist has advised you to use this product, stop wearing the contact lenses until 24 hours after the end of the 5 day treatment

•    you suffer from raised pressure in the eyes (glaucoma) or dry eyes

•    you had eye surgery or laser treatment in the last six months

•    you are using, or have recently used, any other eye drop or eye ointment

•    you are suffering from other eye problems or experience any visual disturbances

•    you have an eye infection which keeps coming back.

Other medicines and Chloromytol Eye Drops

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

Talk to your doctor or pharmacist, particularly if you are taking any of the following:

•    medicines for cancer

•    medicines for the immune system such as azothioprine.

Pregnancy, breast-feeding 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

You may have blurred vision after using these eye drops. If this happens do not drive, or use any machines, until your vision is clear.

Chloromytol Eye Drops contains phenylmercuric nitrate:

This medicine contains phenylmercuric nitrate as a preservative and this may cause allergic reactions.

3. How to use Chloromytol Eye Drops

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

For use in adults and children of all ages.

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.

Check the seal on the bottle is not broken before first use: if it is, do not use the drops and return them to the pharmacy where you bought them.

Apply the drops into to the affected eye only. Always follow the instructions.

1.    Wash and dry your hands.

2.    Break the seal when removing the cap for the first time.

3.    Avoid contaminating the tip of the dropper by touching the eye or surrounding areas, or even breathing on it.

4.    Tilt your head back or lie down.

5.    Bring the tip of the bottle held nozzle downwards close to your affected eye.

6.    Pull down the bottom eye-lid of the affected eye gently using a clean finger.

7.    Release one drop of the medicine into the space between the eye and eye-lid by squeezing the bottle gently.

8.    Allow the eyelids to close for a moment.

9.    If both eyes needs treatment put one drop into each eye following steps 4 to 8.

How much to use:

•    The recommended dose is one drop every 2 hours for the first 48 hours, and then

•    one drop every 4 hours.

Use the drops during waking hours only. If symptoms worsen at any stage, or do not improve within 48 hours, seek the advice of a doctor. Do not stop because you feel better: it is important to finish the course of treatment.

Do not use this medicine for more than five days.

If you use more Chloromytol Eye Drops than you should

Wash your eye with plenty of cool water. If any painful symptoms continue after this, you should tell your doctor immediately. If you cannot do this, you should go to your nearest hospital accident and emergency (casualty) department taking the medicine and packaging with you.

This medicine should not be taken by mouth; however, if you swallow the drops accidentally you should contact your doctor or pharmacist at once.

If you forget to use Chloromytol Eye Drops

Apply it as soon as you remember unless, it is near time for your next dose. Do not apply a double dose to make up for a forgotten dose.

If you stop using Chloromytol Eye Drops

If you stop treatment with Chloromytol Eye Drops before completing treatment your eye infection may not completely clear. Speak to your doctor or pharmacist before stopping Chloromytol 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, this medicine can cause side effects, although not everybody gets them.

Stop using Chloromytol Eye Drops immediately and see a doctor if you get:

•    allergic effects such as itchy skin, rash, swelling of the face, lips, tongue or throat, wheeziness or difficulty breathing, fever

•    severe tiredness, sore throat, bruising easily or being unable to overcome infection.

Other side effects

Not known (frequency cannot be estimated from the available data)

•    Stinging or burning in your eyes. This should last for only a short time, immediately after using the eye drops

•    Fever

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 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 can help provide more information on the safety of this medicine.

5.    How to store this medicine

Replace the cap on the bottle securely after use and keep the bottle in the outer carton in order to protect from light.

Store between 2°C and 8°C (in a refrigerator).

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month.

Throw away any of this medicine left at the end of the 5-day course of treatment or, return it to the pharmacy where you bought it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Chloromytol Eye Drops contains

•    The active substance is chloramphenicol. Each 1ml of the drops contains 5mg of chloramphenicol as a 0.5% w/v solution.

•    The other ingredients are borax, boric acid, phenylmercuric nitrate and purified water.

What Chloromytol Eye Drops looks like and contents of the pack

Chloromytol Eye Drops is bright, colourless to faint yellow aqueous solution, practically clear and practically free from particles. Chloromytol Eye Drops is supplied in flexible polyethylene bottles incorporating a polyethylene plug and cap assembly. Bottle size is 10ml.

Marketing Authorisation Holder:

Mercury Pharmaceuticals Ltd., capital house, 85 King William street, London EC4N7BL, UK Manufacturer:

Lomapharm, Rudolf Lohmann GmbH KG, Langes Feld 5, D-31860 Emmerthal, Germany.

This leaflet was last revised in April 2016.

Chloromytol is a registered trade mark of Mercury Pharma Group Limited