Samsca 7.5 mg, 15mg and 30mg Tablets
*Company:
Otsuka Pharmaceutical UK Ltd.Status:
No Recent UpdateLegal 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 June 2022
File name
Samsca_II-0046-G_CCDS_DDI updates_12May2022_Ireland_PIL.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Section 2
Minor editorial changes in several sections of the PL
Updated on 20 June 2022
File name
Samsca_II-0046-G_CCDS_DDI updates_12May2022_Ireland_SmPC.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.5
Section 5.2
Minor editorial changes in several sections of the SmPC
Updated on 16 March 2021
File name
Samsca-UK site deletion_EMEA_H_C_000980_IA_0043 Ireland PIL.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.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.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).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).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.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.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