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In this leaflet:

Miochol -E

20mg Powder and Solvent for instillation
solution for intraocular use
acetylcholine chloride



Some people MUST NOT have Miochol-E.

What Miochol-E is and what it’s used for

2. Things to consider before you are given Miochol-E

Talk to your doctor if:

3. How Miochol-E is used

4. Possible side effects
5. How to store Miochol-E
6. Further information

Patient Information Leaflet
Your doctor has decided to use Miochol-E to help treat
your condition.
Please read this leaflet carefully before you are
treated. It contains important information. Keep
the leaflet in a safe place because you may want to read
it again. If you have any other questions, or if there is
something you don’t understand, please ask your doctor
or nurse.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or nurse.
This product will usually be referred to as Miochol-E in
this leaflet.

Things to consider before you are given Miochol-E


What Miochol-E is and what it’s used for

The Miochol-E pack includes a vial containing the
Miochol-E powder, and an ampoule containing a liquid
which is used to make up the irrigation solution. There is
also a small filter hub device.
The active ingredient in Miochol-E is called acetylcholine
chloride. This is one of a group of medicines called
parasympathomimetics (neurohormones). It is involved
with the transmission of nerve impulses in the body.
Miochol-E is used during cataract surgery and other
types of eye surgery. It is used to make the pupil (at the
front of the eye) contract. This helps the surgeon carry
out the operation.

You think you may be allergic to acetylcholine
chloride or to any of the other ingredients. (These are
listed at the end of the leaflet.) Some of the symptoms
of an allergic reaction may include 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.
You are pregnant or breastfeeding.

Are you taking other medicines?
Some medicines can interfere with the way Miochol-E
works. Tell your doctor or nurse if you are applying
preparations containing NSAIDs (non-steroidal antiinflammatory drugs, e.g. ibuprofen or diclofenac) to your
skin to treat pain and swelling.
Always tell your doctor or pharmacist about all the
medicines you are taking. This means medicines you have
bought yourself as well as medicines on prescription from
your doctor.
Will there be any problems with driving or
using machinery?
Your vision may be affected both by the eye surgery and
by the use of Miochol-E. You should not drive or use
machinery while you have any problems.

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Warning: Do not use if blister or peelable backing
is damaged or broken. Open under aseptic
conditions only. The contents of the unopened
blister are guaranteed to be sterile.
How to prepare Miochol-E

Inspect unopened
blister to ensure that
it is intact. Peel open

2. Aseptically transfer
the ampoule, vial and
filter hub to sterile
field. Maintain asepsis
during preparation of
the solution.
3. Aseptically attach
a sterile 18 to 20
gauge, bevelled
needle to the luer tip
of a sterile disposable
syringe with twisting
motion to ensure a
secure fit.

4. Break open the
ampoule containing
the solvent. The One
Point Cut (OPC)
ampoule must be
opened as follows:
Hold the bottom part
of the ampoule with
the thumb pointing to the coloured point.
Grasp the top of the ampoule with the other
hand, positioning the thumb at the coloured
point and press back to break at the existing
etched mark under the point.
5. Remove the needle protector and withdraw
the solvent from the ampoule into the syringe.
Discard the empty ampoule.
6. Remove and discard the plastic cap from the
top of vial.

Insert the needle
through the centre of
the vial stopper.

8. Transfer the solvent
from the syringe to
the vial.
9. Shake gently to
dissolve drug.

2015-05-07 09:35:26

10. Slowly withdraw the solution from the vial
through the needle into the syringe.
11. Discard needle.
12. Aseptically open the
filter hub pouch.
13. Aseptically attach the
filter hub to the luer
tip of syringe with a
twisting motion to
assure secure fit.
14. Aseptically attach
a sterile blunt tip
irrigation cannula
to male luer of filter
prior to intraocular
15. Discard appropriately
after use. Do not
reuse the filter hub.
The solution must be mixed just before use, since
aqueous solutions of acetylcholine are unstable.
Do not use unless a clear and colourless solution
is produced.
For single use only. Discard any unused solution.

Miochol-E should not be re-sterilised. The filter
hub is recommended only for use with Miochol-E.
Aspiration through the filter is not recommended.
However, if utilised, discard needle and syringe
filter to prevent recontamination of fluids during
injection. Do not aspirate and inject through the
same filter.
How to store Miochol – E

3. How Miochol-E is used

Your surgeon will work out the correct dose of Miochol-E
for you. In most cases between 0.5 and 2 ml will be a
suitable dose. The same dose is used both for adults and
the elderly.
Your surgeon will determine when to use Miochol-E. In
cataract surgery Miochol-E should only be used after the
replacement lens has been inserted into the eye.

slow heart rate, dizziness or lightheadedness due to
low blood pressure, flushing, breathing difficulties
and sweating.

If any of these side effects are severe or last for more
than a few days, or if you notice anything else not
mentioned here, please tell the doctor or nurse.
5. How to store Miochol-E

Keep all medicines out of the reach and sight of children.

Do not store Miochol-E above 25°C. Do
not freeze.

Miochol-E is applied drop by drop into the eye during
surgery. (This is called intraocular irrigation.)

Do not use any Miochol-E after the expiry
date printed on the box.

Miochol-E should not be stored above 25°C. It should not
be frozen.

Do not use any Miochol-E pack that is
damaged or shows signs of tampering.

The solution will be made up just before it is needed
by a healthcare professional. The use of Miochol-E
in children has not been studied, and therefore it is
not recommended.

It should not be used after the expiry date which is printed
beside the letters “EXP” on the carton and the blister. The
expiry date refers to the last day of that month.

Keep Miochol-E out of the reach and sight
of children.

What if you are given too much?
If you are given more Miochol-E than you need, your
doctor may need to give you an injection of either
atropine sulphate or adrenaline to control symptoms.
Symptoms of overdose may include slow heart rate,
low blood pressure, flushing, breathing difficulties and

Possible side effects

Miochol-E is suitable for most people, but, like all
medicines, it can sometimes cause side effects.
In isolated cases it has been reported that using
Miochol-E has made the cornea (the transparent layer
which protects the front of the eye) become cloudy or
swollen. This may affect your vision.
The following symptoms which are due to Miochol-E
being absorbed into the body’s circulation from the eye,
have also been reported rarely:

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It should not be used if the blister or peelable backing is
damaged or broken.
The re-constituted solution should be used immediately.

Further Information

Each pack of Miochol-E contains a blister and a filtering
hub device.
The blister contains a vial of white powder and an
ampoule of clear, colourless solvent. The vial contains
20 mg of acetylcholine chloride as active ingredient
and the inactive ingredient, mannitol. The ampoule
contains 2 ml of solvent which contains sodium acetate
trihydrate, magnesium chloride hexahydrate, potassium
chloride, calcium acetate trihydrate, magnesium chloride
hexahydrate, potassium chloride, calcium chloride
dihydrate and water for injections.
The Miochol-E powder must be reconstituted with the
solvent before it is used. The reconstituted solution
is a clear, colourless solution providing 10 mg/ml of
acetylcholine chloride (20 mg/2 ml).

The filtering hub device has a 5 micron filter and a luer lock.
Marketing Authorisation holder is
Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Authorisation Number:
UK - PL 13757/0017 (powder)
- PL 13757/0018 (diluent)
Republic of Ireland - PA 1245/2/1
The manufacturer responsible for release to the market is
Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Sanofi S.p.A.
Località Valcanello
03012 Anagni (FR)
Laboratoire Chauvin Avenue Jean Monnet ZI Ripotier
07200 Aubenas France
This leaflet was revised in April 2015.
If you would like any more information, or would like the
leaflet in a different format, please contact +44 (0) 1748
828864 (UK)
or +44 (0) 1748 828849 (Republic of Ireland).
Miochol®-E is a registered trademark of Bausch & Lomb Incorporated.
©Bausch & Lomb Incorporated.


2015-05-07 09:35:27

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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.