What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00014/5181R.


Boots Pharmacy Antibiotic Eye Drops

Information for the user

Boots Pharmacy Antibiotic Eye Drops

(Chloramphenicol 0.5% w/v)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat bacterial conjunctivitis. However, you still need to use it carefully to get the best results from it.

  • Keep this leaflet, you may need to read it again
  • Ask your pharmacist if you need more information or advice
  • You must contact a pharmacist or doctor if your symptoms worsen at anytime, or do not improve after 48 hours

What this medicine is for

This medicine contains chloramphenicol, an antibiotic, which acts to treat bacterial infections.

It can be used for the treatment of acute bacterial conjunctivitis. Conjunctivitis is an infection of the lining that covers the front of the eye. When you have bacterial conjunctivitis the white part of one or both of your eyes will be red and/or your eyelids will be red and swollen. There will be a sticky discharge from the eye, which may make it hard to open your eye when you wake up, and your eye may feel “gritty” or “irritated”.

These eye drops are not suitable for treating serious eye infections (see “!Talk to your doctor”).

Before you use this medicine

This medicine can be used by adults and children aged 2 years and over. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

Do not use:

  • If you are allergic to chloramphenicol or any of the ingredients
  • If you have ever had problems with your bone marrow or blood when using chloramphenicol in the past (this includes capsules, injections and eye drops) – your doctor will have told you this
  • If you have a family history of blood “dyscrasias” – a condition which can cause problems such as tiredness, fatigue, unusual bruising, or an increase in the number of infections that you get
  • If you are pregnant or breastfeeding, unless your doctor tells you to

Talk to your doctor:

  • If you have any of the following symptoms of a serious eye infection:
    • your eyesight has been affected by the infection – you may have loss of sight, reduced sight, blurred vision or see halos around lights
    • you are sensitive to bright lights
    • you have pain within the eye
    • your eye looks cloudy or the pupil of your eye looks unusual
    • your eye is swollen and you have rash on your face

You will need antibiotic tablets or injections to treat these infections.

You should also talk to your doctor:

  • If you have a foreign body (e.g. a splinter) in your eye which has not been removed
  • If you have an eye infection that keeps coming back often
  • If you have had eye surgery or laser treatment in the last six months
  • If you have raised pressure in the eye (glaucoma), dry eyes syndrome or an eye injury, or you have had one of these before
  • If you are using any other eye drops or eye ointments
  • If you wear contact lenses – If your doctor tells you to use this medicine, see ‘Other important information’

Other important information

Do not use this medicine for long periods of time or to treat an infection that keeps coming back. If you do the infection may become resistant to this medicine and will be difficult to treat if you get it again.

Driving and using machines: This medicine can cause blurred vision. Do not drive or use machines until you are sure that you are not affected.

If you wear contact lenses: If your doctor or contact lens practitioner has advised you to use this medicine do not wear your contact lenses during the course of treatment.

Wear your glasses instead.

If you wear soft contact lenses: The preservative in this medicine may damage them. Wait for at least 24 hours after you last use the medicine before wearing your lenses again.

Information about some of the ingredients: Phenylmercuric nitrate may cause allergic reactions.

If you take other medicines

Before you use this medicine, make sure that you tell your pharmacist about any other medicines you might be using at the same time, particularly the following:

  • Medicines that suppress your bone marrow such as drugs used to treat cancer

If you are unsure about interactions with any other medicines, talk to your pharmacist.

How to use this medicine

Check that the seal is not broken before first use. If it is do not use the drops.

For use in the eyes only.

Follow the directions below which show you how to put the drops into your eye.

Adults and children of 2 years and over: put one drop into the infected eye Or if both eyes are infected put one drop into each eye. Use every 2 hours for the first 48 hours, then every 4 hours.

Use the medicine for 5 days. Do not stop using the medicine before then, even if you feel better, because this could make your condition worse.

It is only necessary to use this medicine during the day when you are awake. You do not need to wake yourself up in the night to use it.

If you forget to use the drops: Use them as soon as you remember, and then carry on as normal. If it is almost time for the next dose, wait until the normal time. Never double up on the dose to make up for the missed one.

If your symptoms do not begin to improve within 48 hours talk to your doctor.

If your symptoms worsen at any time during treatment see a doctor at once.

Do not use for children under 2 years.

Directions

Do not:

  • Breathe on or touch the dropper nozzle
  • Touch the eyes or eyelids with dropper nozzle
  • Share you eye drops with anyone else

1. Wash and dry your hands
2. Open the bottle. Take care that the tip of the dropper bottle does not touch your eye, the skin around your eye or your fingers.
3. Tilt your head backwards while seated, or lie down on your back
4. Place the tip of the bottle close to your eye. Gently pull the lower eye lid downwards and look up
5. Squeeze the bottle gently and let one drop fall into the space between the lower eye lid and the eye
6. Close your eye for a moment
7. If both eyes are infected repeat steps 3 to 6 for the other eye
8. Replace the cap securely after use

Possible side effects

Most people can use this medicine without any problems but sometimes you may notice some side effects.

If you notice any of the following serious side effects, stop using the medicine and see your doctor at once.

  • Swelling of the lips, throat or face, difficulty breathing, a sore, red itchy or lumpy rash, fever – these are symptoms of a severe allergic reaction

If you notice any of the following side effects, talk to your doctor or pharmacist:

  • Severe tiredness or easy bruising - this may be a sign of bone marrow depression

You may notice a temporary burning or stinging sensation when you put the drops in your eyes.

If any side effect becomes severe, or if you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Store this medicine in a refrigerator between 2°C and 8°C. Store it in the original package to protect it from light.

Keep this medicine in a safe place out of the sight and reach of children.

Do not use this medicine after the Use By date on the carton.

Throw away any medicine left at the end of the 5 day course.

What is in this medicine

These drops contain Chloramphenicol 0.5% w/v, which is the active ingredient.

As well as the active ingredient, these drops also contain purified water, boric acid, borax and phenylmercuric nitrate.

The pack contains 10 ml of eye drops.

Who makes this medicine

Manufactured for the Marketing Authorisation holder

The Boots Company PLC
Nottingham
NG2 3AA

by

Hamol Limited
Nottingham
NG90 2DB

PL 00014/5181R

Leaflet prepared January 2008

If you would like any further information about this product, please contact

The Boots Company PLC
Nottingham
NG2 3AA

BTC12857 vH 28/02/08