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; GTIN: 5014124374072

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 00156/0048
  • Last update:
  • 30-01-2019

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

Chloramphenicol 0.5% Eye Drops

What is in this leaflet:

What Chloramphenicol Eye Drops are and what

they are used for

What you need to know before you use

Chloramphenicol Eye Drops

How to use Chloramphenicol Eye Drops

Possible side effects

How to store Chloramphenicol Eye Drops

Contents of the pack and other information

1. What Chloramphenicol Eye Drops

are and what they are used for

Chloramphenicol belongs to a group of medicines

called antibiotics. An antibiotic is a medicine which

is used for the treatment of a variety of infections

caused by bacteria. Chloramphenicol Eye Drops

are used in both adults and children for the

treatment of a wide range of eye infections caused

by bacteria.

2. What you need to know before you

use Chloramphenicol Eye Drops

Do not use Chloramphenicol Eye Drops if:

you are allergic to chloramphenicol or any of

the other ingredients of this medicine listed in

section 6

· you or someone in your family ever had a blood

disorder or bone marrow disease including

anemia (decrease in the number of red blood

cells) when using chloramphenicol in the past.

· you have a family history of “dyscrasias”, a

condition which can cause tiredness, bruising

and an increased risk of infections

Warnings and precautions

Talk to your doctor or pharmacist before using

Chloramphenicol Eye Drops if

· you have visual disturbances

· you have severe pain in the eye

· you are sensitive to light

· your eye is inflamed and you have a rash on the

scalp or face

· your eye looks cloudy

· your black or coloured part of the eye

looks unusual

· you have a foreign body in the eye

· you have an eye infection that keeps

coming back

· you have glaucoma (raised pressure in the eye)

· you have dry eyes

· you have eye injury or eye surgery

· you are currently using any other eye drops or

eye ointment

Take special care:

If you develop a new eye infection during this

treatment, you should stop using the drops and

speak to your doctor.

If you use chloramphenicol eye drops for a long

time, your doctor may do some blood tests to

check for any problems.

Other medicines and Chloramphenicol

Eye Drops

Tell your doctor or pharmacist if you are using,

have recently used or might use any other

medicines.

In particular, tell your doctor if you are taking any

of the following:

medicines for cancer such as methotrexate

medicines for the immune system such as

azathioprine

the dietary supplement chymotrypsin

Pregnancy and breast-feeding

Chloramphenicol should not be used during

pregnancy and breast-feeding unless considered

essential by your doctor, as the effects are

unknown. If you are a 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

Chloramphenicol Eye Drops can cause temporary

blurring of vision after application. Wait until your

vision is clear before driving or using machines.

Chloramphenicol contains

Chloramphenicol eye drops contain

phenylmercuric nitrate as a preservative which

may cause allergic reaction. Do not wear contact

lenses during treatment.

3. How to use Chloramphenicol

Eye Drops

Always use this medicine exactly as your doctor or

pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

Contact lenses should be taken out before

treatment with Chloramphenicol Eye Drops.

Instructions for use

Wash your hands well before use

Remove the outer cap. You may find it easier to

apply your drops in front of a mirror.

Tilt the head back and pull the lower lid of the

eye out to form a pocket

Hold the container between the thumb and

middle finger of the other hand, turn the

container upside down near to the eye, try not

to touch the eye with the nozzle

Apply enough pressure to

the container to release one

to two drops

Blink the eye a few times

If you think that you have missed the eye, then

insert another drop

Repeat in the other eye if you have been told

to use Chloramphenicol Eye Drops in both eyes

Replace the outer cap on the container,

trying not to touch the applicator tip with

anything, including the eye or the fingers

10. Wash your hands.

How much to use

One to two drops should be applied to each

affected eye up to six times daily or more

frequently if required. Severe infections may

require one or two drops every fifteen to twenty

minutes initially; reducing the frequency of use as

the infection is controlled.

Prolonged use of Chloramphenicol Eye Drops is

not advisable. You should not use this product for

longer than 5 days at a time unless your doctor has

told you otherwise.

Use in children:

Dosage adjustment may be necessary in newborn

infants to reduce the risk of adverse effects. The

maximum duration of treatment is 10-14 days.

If you use more chloramphenicol than

you should

Chloramphenicol Eye Drops are for external use

only. If you suspect someone has swallowed any

Chloramphenicol Eye Drops, contact your doctor

or go to the accident and emergency department

of your local hospital at once. Always take the

container with you, if possible, even if empty.

If you accidentaly apply too much drops, you

should wash your eye with plenty of water, if any

painful symptoms continue after this, you should

tell your doctor immediately.

If you forget to use Chloramphenicol

Eye Drops

Try not to miss doses. If you do miss a dose, do not

worry, just carry on as normal. Do not use extra

drops to make up.

4. Possible side effects

Like all medicines, this medicine can cause side

effects, although not everyone gets them.

Stop using your medicine and tell your doctor

or pharmacist immediately if you experience the

following side effects:

· Wheeziness (shortness of breath), fever, swelling

of your face, lips or tongue, itching or rash

with swelling of skin (the rash could be puffy

(swollen) or blotchy, or look like little blisters.

· A sore throat, bruising or being unable to

overcome an infection. On very rare occasions,

patients using chloramphenicol have had

changes in their blood cells causing severe

tiredness or easy bruising

Possible side effects include:

burning

stinging

itching

inflammation of the skin (dermatitis).

Rare side effects include:

damage to parts of the eye

bone marrow depression (a condition where the

marrow is unable to produce red blood

cells)

a reduced production and death of red blood

cells (anaemia)

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: 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 Chloramphenicol

Eye Drops

Keep out of the sight and reach of children.

Do not use Chloramphenicol Eye Drops after the

expiry date printed on the bottle label. The expiry

date refers to the last day of the month. Once you

have opened the bottle use within 4 weeks.

You are advised to dispose of the bottle once you

have finished your 5 day course of treatment.

This medicine needs to be stored upright between

2-8°C (in a refrigerator). Protect from light. Do not

allow it to freeze.

Medicines should not be disposed of via

wastewater or household waste. Ask your

pharmacist how to dispose of medicines no longer

required. These measures will help to protect the

environment.

6. Contents of the pack and other

information

What Chloramphenicol Eye Drops contains

The active ingredient is Chloramphenicol 0.5%

w/v.

The other ingredients are Purified Water, Boric

Acid, Borax and Phenylmercuric Nitrate 0.002%

w/v.

What Chloramphenicol Eye Drops look like

and contents of the pack

Chloramphenicol Eye Drops are supplied in plastic

bottles, each bottle containing 10ml of sterile

solution.

Marketing Authorisation Holder:

Martindale Pharmaceuticals Ltd.

Bampton Road, Romford, RM3 8UG, England

Manufacturer:

FAMAR S.A

63.Ag Dimitriou str.

17456 Alimos, Athens

Greece

If you would like any more information, or

would like the leaflet in a different format,

please contact Medical Information at the

above address.

Product Licence Numbers:

PL 00156/0048

HK – 09064

This leaflet was last updated February 2017

Read all of this leaflet carefully before you use start using this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again

If you have any further questions, please ask your doctor or pharmacist

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4

PACKAGE LEAFLET: INFORMATION FOR THE USER

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Chloramphenicol

Continued overleaf

100mm Measurement Verification Bar

D03682