Samsca 7.5 mg, 15mg and 30mg Tablets
- Name:
Samsca 7.5 mg, 15mg and 30mg Tablets
- Company:
Otsuka Pharmaceutical UK Ltd.
- Active Ingredients:
- 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
(Click to Download)XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What Samsca is and what it is used for
1. What Samsca is and what it is used for
2. What you need to know before you take Samsca
2. What you need to know before you take Samsca
3. How to take Samsca
3. How to take Samsca
4. Possible side effects
4. Possible side effects
5. How to store Samsca
5. How to store Samsca
6. Contents of the pack and other information
6. Contents of the pack and other information
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Otsuka Pharmaceutical UK Ltd.
Company Products
| Medicine Name | Active 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 |
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 11 January 2021 SPC
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 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 SPC
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 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 SPC
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 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 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC 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