Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about being given this medicine,
speak to your doctor or pharmacist.
1. Why am I being given Miochol-E?
Miochol-E contains the active ingredient acetylcholine chloride. Miochol-E is used
to constrict the pupil of the eye during surgery for removal of a cataract (the lens
inside the eye) and other types of eye surgery.
2. What should I know before being given Miochol-E?
Do not use if you are allergic to any medicine containing acetylcholine chloride or
to any of the ingredients listed at the end of this leaflet. Always check the ingredients
to make sure you can use this medicine. Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Miochol-E and affect how it works. Check with your
doctor or pharmacist if you are not sure about what medicines, vitamins or supplements
you are taking and if these affect Miochol-E.
4. How is Miochol-E given?
Miochol-E is given as a single dose during eye surgery. Your doctor will prepare and
administer Miochol-E for you. In most cases, 0.5 to 2 mL is enough to constrict the
pupil of the eye sufficiently.
5. What should I know while being given Miochol-E?
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Things you should do
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Keep all of your doctor's appointments so that your progress can be checked.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Miochol-E
affects you. It may cause blurred vision for a short time when it is instilled into
the eye. Allow enough time to regain clear vision before driving or using machines.
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6. Are there any side effects?
All medicines can have side effects. If they do occur, they are usually minor and
temporary. Do not be alarmed by this list. You may not experience any of them. Less
serious side effects include: dizziness or lightheadedness due to low blood pressure,
flushing, sweating, abnormal vision. Serious side effects include: slow heart rate,
shortness of breath, wheezing or difficulty breathing, swelling of the face, lips,
tongue or other parts of the body, rash, itching or hives on the skin.
Active ingredient:
Acetylcholine chloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about being given Miochol-E. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about being given Miochol-E.
Where to find information in this leaflet:
1. Why am I being given Miochol-E?
Miochol-E contains the active ingredient acetylcholine chloride. Miochol-E belongs to a group of medicines called parasympathomimetics.
Miochol-E is used to constrict the pupil of the eye during surgery for removal of
a cataract (the lens inside the eye) and other types of eye surgery.
2. What should I know before being given Miochol-E?
Warnings
Do not use Miochol-E if:
You are allergic to any medicine containing acetylcholine chloride.
You are allergic to any of the ingredients listed at the end of this leaflet. Always
check the ingredients to make sure you can use this medicine.
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?
This medicine has been developed for use in the eye only. It should not be swallowed
or injected.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor 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 and Miochol-E may interfere with each other. These medicines may be
affected by Miochol-E or may affect how well it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Miochol-E.
4. How is Miochol-E given?
Miochol-E is given as a single dose during eye surgery. If the surgery is for removal
of a cataract, it is given following placement of a new lens inside the eye.
Your doctor will prepare and administer Miochol-E for you.
How much is given
In most cases, 0.5 to 2 mL is enough to constrict the pupil of the eye sufficiently.
How it is given
Miochol-E is made into a solution immediately before use. This solution is run through
a small tube into the front chamber of the eye.
If you are given too much Miochol-E
If you are given more Miochol-E than you need, your doctor may need to give you an
injection of either atropine sulfate or adrenaline to control symptoms.
Symptoms of overdose may include slow heart rate, low blood pressure, flushing, breathing
difficulties and sweating.
Because acetylcholine is rapidly broken down by the body, symptoms of overdose are
unlikely to occur.
5. What should I know while being given Miochol-E?
Things you should do
Keep all of your doctor's appointments so that your progress can be checked.
Driving or using machines
Do not drive or operate machinery until you have recovered from your eye surgery and
your vision is normal.
6. Are there any side effects?
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.
Tell your doctor as soon as possible if you do not feel well while you are being treated
with Miochol-E.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Side effects
Tell your doctor 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 online (in Australia, go to
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 or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Miochol-E contains
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Active ingredient (main ingredient)
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Acetylcholine chloride (10 mg/mL)
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Other ingredients (inactive ingredients)
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mannitol
sodium acetate
magnesium chloride
potassium chloride
calcium chloride
water for injection
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Do not use this medicine if you are allergic to any of these ingredients.
What Miochol-E looks like
Miochol-E (AUST R 118510) comes in a clear glass vial and a glass ampoule: the vial
contains a white powder (20 mg of acetylcholine chloride) and the ampoule contains
a clear, colourless solution (2 mL of diluent for reconstitution of the powder). The
contents are mixed immediately before use to form a clear, colourless solution.
Who distributes Miochol-E
In Australia, Miochol-E is supplied by:
Bausch & Lomb (Australia) Pty Ltd
Level 2, 12 Help Street
Chatswood, NSW 2067
Phone: 1800 251 150
This leaflet was prepared in April 2025.