METOPIRONE 250 mg

  • Name:

    METOPIRONE 250 mg

  • Company:
    info
  • Active Ingredients:

    Metyrapone

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/06/20

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Summary of Product Characteristics last updated on medicines.ie: 2/6/2020

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HRA Pharma UK and Ireland Limited

HRA Pharma UK and Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name ellaOne 30 mg Active Ingredients Ulipristal acetate
Medicine Name ellaOne 30 mg film-coated tablet Active Ingredients Ulipristal acetate
Medicine Name Ketoconazole HRA (ketoconazole, 200mg tablets) Active Ingredients Ketoconazole
Medicine Name Lysodren 500 mg tablets Active Ingredients Mitotane
Medicine Name METOPIRONE 250 mg Active Ingredients Metyrapone
Medicine Name Norlevo 1.5mg tablet Active Ingredients Levonorgestrel
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 2 June 2020 PIL

Reasons for updating

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

Updated on 2 June 2020 PIL

Reasons for updating

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

Updated on 2 June 2020 SmPC

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 PIL

Reasons for updating

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

Updated on 26 April 2019 SmPC

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 SmPC

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 13 February 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 1 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 February 2017 PIL

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 SmPC

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 SmPC

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 8 April 2015 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 29 April 2013 SmPC

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 PIL

Reasons for updating

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

Updated on 5 March 2012 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 February 2012 SmPC

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