What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 13757/0017.


Miochol-E, 20mg, Powder and Solvent for Solution for Intraocular Irrigation

Miochol®-E

20mg Powder and Solvent for instillation solution for intraocular use

acetylcholine chloride

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.

In this leaflet:

1. What Miochol-E is and what it’s used for
2. Things to consider before you are given Miochol-E
3. How Miochol-E is used
4. Possible side effects
5. How to store Miochol-E
6. Further information

1. 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.

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

Some people MUST NOT have Miochol-E.

Talk to your doctor if:

  • 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 anti-inflammatory 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.

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.

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

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.

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 sweating.

4. 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:

  • 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.

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

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.

It should not be used if the blister or peelable backing is damaged or broken.

The re-constituted solution should be used immediately.

6. 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
Germany

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
Germany

or

SANOFI S.P.A.
Via Valcanello, 4
03012 Anagni (FR)
Italy

or

Laboratoire Chauvin Avenue Jean Monnet ZI Ripotier
07200 Aubenas
France

This leaflet was revised in January 2017.

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.

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