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Miphtel 20mg Powder and Solvent for solution for intraocular irrigation

Active Ingredient:
acetylcholine chloride
Company:  
ParaPharm Development Limited See contact details
ATC code: 
S01EB09
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 09 Jun 2023
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 24653/0001.

{printer} Print patient leaflet as text only

Miphtel 20mg powder and Solvent for Solution for Intraocular irrigation

Miphtel 20 mg powder and solvent for solution for intraocular irrigation

(Acetylcholine chloride)

Patient Information Leaflet
Read all of this leaflet carefully before you are given this medicine.

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.

In this leaflet:

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

1. WHAT MIPHTEL IS AND WHAT IT IS USED FOR

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.

2. BEFORE USING MIPHTEL
You must not be given MIPHTEL:

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:

  • Are you taking β-blockers (drugs used to treat high blood pressure and certain heart conditions)?
  • Are you taking or have you recently taken non-steroidal anti-inflammatory agents (used to treat pain and swelling)?
  • Do you suffer from bronchial asthma?
  • Do you suffer from heart disease such as heart failure?
  • Do you have an overactive thyroid gland?
  • Do you suffer from gastrointestinal complaints?
  • Do you have a stomach ulcer?
  • Do you have any difficulty passing urine?
  • Do you suffer from Parkinson's disease?

Taking other medicines

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:

  • β-blockers (used to treat high blood pressure and certain heart conditions)
  • topical non-steroidal anti-inflammatory agents (used to treat pain and swelling).

Pregnancy and Breastfeeding

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.

Driving and using machines

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.

3. HOW MIPHTEL IS GIVEN

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 too much is given

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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, MIPHTEL can have side effects, even when used as directed.

The following side effects have rarely been reported:

  • Slow heart rate
  • Low blood pressure
  • Flushing
  • Breathing difficulties
  • Sweating
  • Cloudiness of the cornea

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.

5. STORING MIPHTEL

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.

6. FURTHER INFORMATION
What MIPHTEL contains

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).

What MIPHTEL looks like and contents of the pack

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 and Manufacturers

Marketing Authorisation Holder:

Farmigea S.p.A.
Via G.B. 0liva
8 - I-56121 Pisa
Italy

Manufacturers responsible for batch release:

Alfasigma S.p.A.
Via Enrico Fermi
1 - I-65020 Alanno
Pescara
Italy

Farmigea S.p.A. Via GB. Oliva
8 - I-56121 Pisa
Italy

This leaflet was last revised in February 2018

912201/03

ParaPharm Development Limited
Company image
Address
Building 1410, Arlington Business Park, Theale, Reading, RG7 4SA, UK
Telephone
+44 (0)118 2210150
Fax
+44 (0)118 2210151
Medical Information Direct Line
+44 (0)1183 217 100
Medical Information e-mail
[email protected]