Samsca 7.5 mg, 15mg and 30mg Tablets *

  • Company:

    Otsuka Pharmaceutical UK Ltd.
  • 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

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 16 March 2021

File name

Samsca-UK site deletion_EMEA_H_C_000980_IA_0043 Ireland PIL_1615910465.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

Section 6: Content of pack and other information

Deletion of UK manufacturer and changes in address of local representative (Ireland & Northern Ireland)

Updated on 16 March 2021

File name

Samsca-UK site deletion_EMEA_H_C_000980_IA_0043 Ireland SmPC_1615910265.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Section 4.4 and 5.1(minor editorial)

 

Updated on 11 January 2021

File name

Samsca Tablets SmPC - Ireland_1610388497.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Samsca SmPC (section 4.4) with the current wording of the lactose statement as per EU excipients guideline.

Additionally, the SmPC (section 5.3 - preclinical data) was updated

Updated on 27 January 2020

File name

Packaging Change PIL (Eire)_1580146984.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

Annex III (B. Package Leaflet)

6. Contents of the pack and other information

Updated on 27 January 2020

File name

Packaging Change SmPC (Eire)_1580146678.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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

Free text change information supplied by the pharmaceutical company

Annex I (SmPC)

6.5 Nature and contents of container

8. MARKETING AUTHORISATION NUMBER(S)

Updated on 07 January 2019

File name

6. PIL MAH change plus 7.5 mg addition - IE_1546867300.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 07 January 2019

File name

8. SPC MAH change plus 7.5 mg addition - IE_1546867682.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

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

Free text change information supplied by the pharmaceutical company

Section 6.5: addition of PVC/Alu perforated unit dose blister

Section 7: change of Marketing Authorisation Holder from Otsuka Pharmaceutical Europe Ltd. to Otsuka Pharmaceutical Netherlands B.V.

Section 8: addition of Marketing Authorisation Numbers EU/1/09/539/007 and EU/1/09/539/008

Section 10: revision of text was 10/2018

 

Updated on 27 July 2018

File name

SAMSCA PIL - Complete FINAL.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 24 July 2018

File name

SAMSCA SmPC - Complete FINAL.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Update of sections 4.4 and 4.8 of the SmPC in order to add a warning and update the safety information on acute liver failure requiring liver transplantation, based post-marketing experience with tolvaptan in autosomal dominant polycystic kidney disease (ADPKD).

Updated on 11 July 2018

File name

Samsca 7.5mg,15mg,30mg SmPC June 2018.docx

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Update of sections 4.3 and 4.4 of the SmPC in order to add a contraindication and a warning on hypersensitivity to benzazepine derivatives, thus aligning the product information to the patient population studied in clinical trials and the RMP for Samsca. The Package Leaflet is updated accordingly.

Updated on 11 July 2018

File name

Samsca 7.5mg,15mg,30mg tabs PIL June 2018.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 09 May 2018

File name

Samsca_7.5_15_30mg_Tabs_SPC_Jun_2017.docx

Reasons for updating

  • New SPC for new product

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

Updated on 08 May 2018

File name

Samsca 7.5, 15, 30mg Tabs PIL Jun 2017.pdf

Reasons for updating

  • New PIL for new product