Samsca 7.5 mg, 15mg and 30mg Tablets

  • Name:

    Samsca 7.5 mg, 15mg and 30mg Tablets

  • Company:
    info
  • Active Ingredients:

    tolvaptan

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/01/20

files-icon(Click to Download)

XPIL

Summary of Product Characteristics last updated on medicines.ie: 27/1/2020

Click on this link to Download PDF directly

Otsuka Pharmaceutical UK Ltd.

Company Products

Medicine NameActive Ingredients
Medicine Name ABILIFY 1 mg/ml oral solution Active Ingredients aripiprazole
Medicine Name ABILIFY 5 mg, 10 mg, 15 mg and 30 mg tablets Active Ingredients aripiprazole
Medicine Name ABILIFY 7.5 mg/ml solution for injection Active Ingredients aripiprazole
Medicine Name Abilify Orodispersable Tablets 10 mg, 15 mg and 30 mg Active Ingredients aripiprazole
Medicine Name Jinarc 15mg, 30mg, 15mg + 45mg, 30mg + 60mg, 30mg + 90mg tablets Active Ingredients tolvaptan
Medicine Name Samsca 7.5 mg, 15mg and 30mg Tablets Active Ingredients tolvaptan
1 - 0 of 6 items.Total: Infinity pages

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 27 January 2020 PIL

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

Reasons for updating

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

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 7 January 2019 PIL

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 7 January 2019

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

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 PIL

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

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

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

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 PIL

Reasons for updating

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

Updated on 9 May 2018

Reasons for updating

  • New SmPC for new product

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

Updated on 8 May 2018 PIL

Reasons for updating

  • New PIL for new product