Skip to Content

VISTAPHENICOL EYE DROPS

Active substance(s): CHLORAMPHENICOL / CHLORAMPHENICOL / CHLORAMPHENICOL

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

D03681

Chloramphenicol 0.5% Eye Drops
Chloramphenicol
Read all of this leaflet carefully before you 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

What is in this leaflet:
1. What Chloramphenicol Eye Drops are and
what they are used for
2. What you need to know before you use
Chloramphenicol Eye Drops
3. How to use Chloramphenicol Eye Drops
4. Possible side effects
5. How to store Chloramphenicol Eye Drops
6. 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
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
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.
Chloramphenicol contains
Chloramphenicol eye drops contain
phenylmercuric nitrate as a preservative which
may cause allergic reaction. Do not wear contact
lenses during treatment.

8. Repeat in the other eye if you have been
told to use Chloramphenicol Eye Drops in
both eyes
9. 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.
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.
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.
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.

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.

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.

3. How to use Chloramphenicol Eye
Drops

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.

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
1. Wash your hands well before use
2. Remove the outer cap. You may find it
easier to apply your drops in front of a
mirror.
3. Tilt the head back and pull the lower lid of
the eye out to form a pocket
4. 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
5. Apply enough pressure to
the container to release one
to two drops
6. Blink the eye a few times
7. If you think that you have
missed the eye, then insert
another drop
Continued overleaf

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).

100mm Measurement Verification Bar

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)

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: 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:
Farmigea S.p.A.
Via G.B. Oliva 6/8
56121 Pisa, Italy
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

D03681

PACKAGE LEAFLET: INFORMATION FOR THE USER

DEVELOPMENT ARTWORK
D03681
Chloramphenicol 0.5% PIL UK PL
00156/0048 Eye drops
135x220mm

06/03/17

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide