METOPIRONE 250 mg *
Pharmacy Only: Prescription

  • Company:

    HRA Pharma UK and Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 20 April 2022

File name

PIL- Metyrapone- Ireland new update Apr 2022_1650449267.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 April 2022

File name

SmPC - Metyrapone- Ireland new update Apr 2022_1650448176.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 02 June 2020

File name

PIL - Meto - April 2020_1591091559.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 02 June 2020

File name

PIL - Meto- Clean- 19.11.2018_1556288629.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to marketing authorisation holder

Updated on 02 June 2020

File name

SmPC - Meto - 2020_1591090784.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 April 2019

File name

PIL - Meto- Clean- 19.11.2018_1556288629.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 26 April 2019

File name

SmPC- Meto- Clean- 19.11.2018_1556288681.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 13 February 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 13 February 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

6.3 Shelf life:

Addition of:

“After opening: 2 months”.

 

10. Date of (partial) revision of text:

Updated as 06 January 2017.

Updated on 01 February 2017

File name

PIL_15283_31.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 February 2017

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 April 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of the Appendix V information (where to report ADR in Ireland)

Updated on 13 April 2015

Reasons for updating

  • Change due to harmonisation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Metopirone texts have been harmonised following a regulatory variation

Updated on 08 April 2015

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 29 April 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 - Qualitative and Quantitative Composition
Excipients with known effects :

Each capsule contains 0.71 mg of sodium ethyl parahydroxybenzoate and 0.35 mg sodium propyl parahydroxybenzoate. The printing ink used to mark the capsule contains trace amounts of soya lecithin

.
Section 3 - Pharmaceutical Form
A white to yellowish-white, oblong, soft gelatin capsule printed with words "Ciba HRA" and "LN" in brown in red ink and having faintly yellowish viscous to jellyy-like contents

Section 6.1 List of Excipients
Sodium ethyl parahydroxybenzoate (E214 E215)
Printing ink (Opacode brown Red) :
Carminic acid (E120)
Aluminium chloride hexahydrate
Sodium hydroxide
Hypromellose
Propylene glycol
Isopropyl alcohol
Purified water Shellac glaze
Iron oxide red (E172)
Iron oxide yellow (E172)
Iron oxide black (E172)
Industrial methylated spirit
Purified water
2-ethoxyethanol
Lecithin (soya, E322)
Titanium dioxide (E171)
Antifoam DC 1510 (Food grade)

Section 10 - Date of Revision of the Text
February 2013

Updated on 26 April 2013

Reasons for updating

  • Change of inactive ingredient
  • Change of manufacturer
  • Change to date of revision
  • Change to appearance of the medicine

Updated on 05 March 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 February 2012

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided