Patient Leaflet Updated 09-Jun-2023 | ParaPharm Development Limited
Miphtel 20mg powder and Solvent for Solution for Intraocular irrigation
Miphtel 20 mg powder and solvent for solution for intraocular irrigation
(Acetylcholine chloride)
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or the medical staff looking after you.
1. What MIPHTEL is and what it is used for
2. Before using MIPHTEL
3. How to use MIPHTEL
4. Possible side effects
5 Storing MIPHTEL
6. Further information
The active substance in MIPHTEL 20mg powder and solvent for solution for intraocular irrigation is acetylcholine chloride. It belongs to a group of substances called parasympathomimetics (neurohormones) involved with the transmission of nerve impulses in the body.
MIPHTEL is used during cataract surgery and other types of eye surgery to make the pupil (at the front of the eye) contract. This helps the surgeon carry out the surgical procedure. If you have any questions about how MIPHTEL works or why this medicine has been prescribed for you, ask your doctor or the medical staff looking after you. It is available only for hospital use.
NOTE: This is a patient information leaflet. Doctors and other health professionals involved in the administration of MIPHTEL should consult the administration instructions for healthcare professionals before use.
If you are allergic (hypersensitive) to acetylcholine chloride or any of the other ingredients (mannitol) of this medicine listed at the beginning of this leaflet.
Children: the use of MIPHTEL in children has not been studied and therefore children must not be given this medicine.
Take special care with MIPHTEL:
If the answer to any of the following questions is 'yes', talk to your doctor before you are given this medicine:
Tell your doctor if you are taking or have recently taken any other medicines, even those you have bought without a prescription. In particular, you should inform your doctor if you are taking:
Tell your doctor if you are or think you may be pregnant.
Tell your doctor if you are breastfeeding.
The doctor will discuss with you the risks and benefits involved.
No studies on the effects on the ability to drive and use machines have been performed.
However, the surgical procedure may impair vision.
You should not drive or use machines until such disturbances have subsided.
This medicine will be given to you only by the surgeon. Your surgeon will work out the correct dose of MlPHTEL for you. In most cases 0.5ml to 2ml of solution is a suitable dose. The solution should be made up just before it is given for intraocular use (i.e. use in the eye). It contains 10mg/ml of acetylcholine chloride (20mg/2ml). Each ampoule of powder and solvent is for single use only.
If you are given more medicine 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. Because acetylcholine is rapidly broken down by the body, symptoms of overdose are unlikely to occur. If you have any further questions on the use of this product ask your doctor or the medical staff looking after you.
Like all medicines, MIPHTEL can have side effects, even when used as directed.
The following side effects have rarely been reported:
If any of these affects you or if you notice any other side effects not mentioned in this leaflet, tell your doctor or the medical staff looking after you.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the label. The doctor should check that the solution is clear and colourless before use.
Do not freeze.
Store in the original package.
Powder ampoule:
Each ampoule contains: acetylcholine chloride 20mg.
Also contains: mannitol (E421), sodium hydroxide (for pH adjustment).
Solvent ampoule: Each ampoule contains water for injections 2ml (for ophthalmic use only).
MIPHTEL is supplied as a powder in a glass container called ampoule that requires reconstitution with the solvent provided in a separate ampoule.
Each pack contains 6 holders each containing one ampoule of powder and one ampoule of solvent.
Marketing Authorisation Holder:
Manufacturers responsible for batch release:
This leaflet was last revised in February 2018
912201/03
Building 1410, Arlington Business Park, Theale, Reading, RG7 4SA, UK
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