CHOLFEN® EYE DROPS
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor, optometrist or pharmacist.
CHOLFEN EYE DROPS contains the active ingredient chloramphenicol. CHOLFEN EYE DROPS
is used to treat an eye infection called bacterial conjunctivitis, which is a bacterial
infection involving the mucous membrane of the surface of the eye.
For more information, see Section 1. Why am I using CHOLFEN EYE DROPS? in the full CMI.
Do not use if you have ever had an allergic reaction to chloramphenicol or any of
the ingredients listed at the end of the CMI.
Talk to your doctor, optometrist or pharmacist if you have any other medical conditions,
take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use CHOLFEN EYE DROPS? in the full CMI.
Some medicines may interfere with CHOLFEN EYE DROPS and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
The dose of CHOLFEN EYE DROPS may be different for each person and their medical condition.
Your doctor, optometrist or pharmacist will recommend the right dose for you.
Usual recommended doses for adults and children (2 years and over):
Instil 1 or 2 drops in the affected eye(s) every two to six hours for two to three
days. The interval between applications may then be increased. Treatment should be
continued for at least 48 hours after the eye appears normal. Do not use for more
than 5 days in total except on medical advice.
More instructions can be found in Section 4. How do I use CHOLFEN EYE DROPS? in the full CMI.
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Things you should do
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Use CHOLFEN EYE DROPS exactly as directed.
Remind any doctor, dentist, optometrist or pharmacist you visit that you are using
CHOLFEN EYE DROPS.
Tell your doctor immediately if you become pregnant while you are using CHOLFEN EYE
DROPS.
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Things you should not do
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Do not use CHOLFEN EYE DROPS for a longer time than your doctor, optometrist or pharmacist
has prescribed.
Do not increase the dose or treat any other complaints without first checking with
your doctor, optometrist or pharmacist.
Do not use CHOLFEN EYE DROPS without checking with your doctor, optometrist or pharmacist.
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Driving or using machines
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Do not drive or operate machinery until you know how CHOLFEN EYE DROPS affects you.
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Looking after your medicine
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Store unopened bottles at between 2-8°C in a refrigerator. Do not freeze. Protect
from light.
After opening, store at room temperature (below 25°C). Discard 4 weeks after opening.
Protect from light.
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For more information, see Section 5. What should I know while using CHOLFEN EYE DROPS? in the full CMI.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
CHOLFEN® EYE DROPS
Active ingredient: chloramphenicol
Consumer Medicine Information (CMI)
This leaflet provides important information about using CHOLFEN EYE DROPS. You should also speak to your doctor, pharmacist or optometrist if you would like
further information or if you have any concerns or questions about using CHOLFEN EYE
DROPS.
Where to find information in this leaflet:
CHOLFEN EYE DROPS contains the active ingredient chloramphenicol, a synthetic antibiotic.
CHOLFEN EYE DROPS is available as eye drops, for external use only.
CHOLFEN EYE DROPS
is used to treat an eye infection called bacterial conjunctivitis, which is a bacterial
infection involving the mucous membrane of the surface of the eye.
The most common symptom is the presence of a sticky yellow-white discharge with mucus
and pus (or glued eyes, especially in the morning on waking). Other symptoms include
a gritty sensation in the eye, redness, irritation and watering of the eyes. The infection
usually starts in one eye and then spreads to the other.
Do not use CHOLFEN EYE DROPS if:
you are allergic to chloramphenicol, or any of the ingredients listed at the end of
this leaflet.
Always check the ingredients to make sure you can use this medicine.
the packaging is torn, broken or shows signs of tampering.
after the expiry date printed on the pack.
Do not give CHOLFEN EYE DROPS to children under 2 years of age unless your doctor or optometrist tells you.
Some of the symptoms of an allergic reaction to CHOLFEN EYE DROPS may include:
Irritation, pain and swelling in the eye
Skin rashes, blisters
Fever.
Check with your doctor if:
you or your family have blood disorders (e.g. anaemia) or problems with bone marrow.
you have an injury to the cornea. Eye preparations may inhibit the healing of the
wound.
you wear contact lenses.
Contact lenses should not be worn during the course of CHOLFEN EYE DROPS treatment.
If you wear hard or disposable contact lenses, you can start using them again after
completing the course of treatment. If wearing soft contact lenses, you should wait
24 hours after completing a course of treatment before starting to use them again.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor, optometrist or pharmacist if you are pregnant or intend to
become pregnant.
Talk to your doctor, optometrist or pharmacist if you are breastfeeding or intend
to breastfeed.
If you have bought this medicine without a prescription and without prior consultation
from a doctor or optometrist, it is important to check the following list. Speak to
your doctor or optometrist if any apply before you start to use CHOLFEN EYE DROPS:
you are allergic to any other antibiotic eye drops or ointments
you are using other eye drops or eye ointments
you have pain within your eye (rather than just feeling sore or gritty)
swelling around the eye
blurred vision or sensitivity to light
limited eye movement
abnormal pupil (the black circle in the centre of the eye)
your eye looks cloudy
there is copious yellow-green purulent discharge that accumulates after being wiped
away
you have injured your eye or there is a foreign body in the eye
you have been welding without eye protection immediately before your eye symptoms
appeared
you have glaucoma
you have dry eye syndrome
you have had similar symptoms in the past
you have had eye surgery or laser treatment in the past six months
you have recently travelled overseas
you are allergic to any other medicines or any foods, dyes or preservatives
you have surgery (including dental surgery) using a general anaesthetic
you feel unwell
you have any other medical conditions.
If you have not told your doctor or optometrist about any of the above, tell them
before you use CHOLFEN EYE DROPS.
Tell your doctor, optometrist or pharmacist if you are taking any other medicines,
including any medicines, vitamins or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
Some medicines may interfere with CHOLFEN EYE DROPS and affect how it works. These
include other eye drops and eye ointments.
These medicines may reduce or increase the effectiveness of CHOLFEN EYE DROPS, reduce
its own effectiveness and/or react with CHOLFEN EYE DROPS resulting in untoward or
sometimes dangerous side effects.
Your doctor, optometrist or pharmacist has more information on medicines to be careful
with or avoid while using this medicine.
Follow all directions given to you by your doctor, optometrist or pharmacist carefully.
They may differ from the information contained in this leaflet.
How much to use
The dose of CHOLFEN EYE DROPS may be different for each person and their medical condition.
Your doctor, optometrist or pharmacist will recommend the right dose for you.
Do not use in children under 2 years of age except on doctor’s advice.
The usual recommended doses are:
CHOLFEN EYE DROPS:
For adults and children (2 years and over): Instill 1 or 2 drops in the affected eye(s)
every two to six hours for 2 to 3 days. The interval between applications may then
be increased. Treatment should be continued for at least 48 hours after the eye appears
normal. Do not use for more than 5 days in total except on medical advice.
If the condition worsens or does not get better after 2 days, seek immediate medical
advice.
How to apply CHOLFEN EYE DROPS
wash hands thoroughly before and after use
open the eye, tilt head back and look upwards
gently pull down the lower lid to form a pouch
approach the eye from the side and hold the bottle dropper near the lid, but do not
let the tip of the dropper touch the eye, eyelids or lashes
apply one drop into the pouch
close the eyes (do not rub them) and try not to blink for a short time
apply gentle pressure for about one minute with a finger to the bridge of the nose
to prevent the medicine being drained from the eye
blot excess solution around the eye with a tissue
if instilling more than one drop in an eye, separate each installation by several
minutes to avoid washing drops out of the eye
To minimise contamination, do not allow the dropper to contact the surface of the
eye.
How long to use CHOLFEN EYE DROPS
CHOLFEN EYE DROPS should not be used for more than 5 days except on medical advice.
If you forget to use CHOLFEN EYE DROPS
If it is almost time for your next dose, skip the dose you missed and use your next
dose when next due.
Otherwise, use it as soon as you remember, and then go back to using it as you would
normally.
If you are unsure about whether to use your next dose, speak to your doctor, optometrist
or pharmacist.
Do not try to make up for missed doses by using more than one dose at a time. This may increase the chance of you getting an unwanted side effect.
If you use too much CHOLFEN EYE DROPS
Accidental ingestion of the drug in adults is unlikely to cause any toxicity due to
the low content of antibiotic, but consult your doctor or Poison Information Centre
(see below).
If the eye drops are accidentally ingested by infants or young children, you should
immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Urgent medical attention may be needed.
Things you should do
Use CHOLFEN EYE DROPS exactly as directed.
Tell all doctors, dentists, optometrists and pharmacists who are treating you that
you are using CHOLFEN EYE DROPS.
Tell your doctor immediately if you become pregnant while you are using CHOLFEN EYE
DROPS.
Always discuss with your doctor, optometrist or pharmacist any problems or difficulties
during or after using this medicine.
Tell your doctor, optometrist or pharmacist if, for any reason, you have not taken
your medicine exactly as prescribed. Otherwise they may think that it was not effective
and change your treatment unnecessarily.
Things you should not do
Do not use CHOLFEN EYE DROPS for a longer time than your doctor, optometrist or pharmacist
has prescribed.
Do not increase the dose, without first checking with your doctor, optometrist or
pharmacist.
Do not use this medicine to treat any other complaints without checking with your
doctor, optometrist or pharmacist.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Do not drive or operate machinery until you know how CHOLFEN EYE DROPS affects you.
CHOLFEN EYE DROPS may distort your vision temporarily. Make sure you know how you
react to it before you drive a car, operate machinery or do anything else that could
be dangerous.
Looking after your medicine
Store unopened bottles in a refrigerator, where the temperature stays between 2-8°C.
Do not freeze. Protect from light.
After opening, store at room temperature (below 25°C). Discard 4 weeks after opening.
Protect from light.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If your doctor, optometrist or pharmacist tells you to stop using CHOLFEN EYE DROPS
or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, optometrist or pharmacist
if you have any further questions.
Less serious side effects
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Less serious side effects
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What to do
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eye irritation or swelling that may include itching or burning
skin rashes or blisters
fever.
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Speak to your doctor, optometrist or pharmacist immediately if you have any of these
side effects.
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Serious side effects
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Serious side effects
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What to do
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Allergic reactions:
fever
rash
swelling of the face, lips, mouth
sore throat that may cause difficulty in swallowing or breathing
shortness of breath
swelling of the hands, feet or ankles.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor, optometrist or pharmacist if you notice anything else that may be
making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor, optometrist or pharmacist before you decide
to stop taking any of your medicines.
This medicine is available over-the-counter without a doctor's prescription.
What CHOLFEN EYE DROPS contains
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Active ingredient
(main ingredient)
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chloramphenicol 5 mg/mL (0.5%)
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Other ingredients
(inactive ingredients)
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borax
boric acid
hypromellose
phenylmercuric nitrate
water for injections
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CHOLFEN EYE DROPS contains the preservative phenylmercuric nitrate (0.002% w/v).
Do not take this medicine if you are allergic to any of these ingredients.
What CHOLFEN EYE DROPS looks like
CHOLFEN EYE DROPS is sterile clear to slightly hazy colourless, odourless, slightly
viscous liquid. Available in 10 mL plastic container (AUST R 349371).
