Chloramphenicol 0.5% eye drops

Main information

  • Trade name:
  • Chloramphenicol 0.5% eye drops
  • Dosage:
  • 5mg/1ml
  • Pharmaceutical form:
  • Eye drops
  • Administration route:
  • Ocular
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Chloramphenicol 0.5% eye drops
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 11030100

Status

  • Source:
  • eMC
  • Last update:
  • 30-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Information for the user

Chloramphenicol 0.5% w/v Eye Drops

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.

X

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.

Age

How much to use

How often to use it

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.

For the first 48 hours use

every 2 hours and then use

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

Wash and dry your hands

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

Place the tip of the bottle close to your eye. Gently pull the lower eye lid downwards and

look up

Squeeze the bottle gently and let one drop fall into the space between the lower eye lid

and the eye

Close your eye for a moment

If both eyes are infected repeat steps 3 to 6 for the other eye

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.

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

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can

help provide more information on the safety of this medicine.

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

MAH: BCM, Nottingham NG2 3AA

Manufacturer: Hamol Limited Nottingham NG90 2DB

Leaflet prepared January 2015

Almus

is a registered trademark.

Component code

PACK MOCK UP BOX

Product Name: Almus Chloramphenicol 0.5% w/v Eye Drops

Product Licence No: PL00014/5181R

Wording Ref: Draft Copy V2, draft issue 3, 02/11/11, AL0079/Lt2, Pharma Code 957

Status: Internally Approved

Pack details: White HDPE/LDPE bottle, white LDPE plug

Pack size: 10 ml

Version No: 1

Date issued: 13/01/2015

Reason for change: addition of Yellow Card warning