Jinarc 15mg, 30mg, 15mg + 45mg, 30mg + 60mg, 30mg + 90mg tablets

  • Name:

    Jinarc 15mg, 30mg, 15mg + 45mg, 30mg + 60mg, 30mg + 90mg tablets

  • Company:
    info
  • Active Ingredients:

    tolvaptan

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/04/20

files-icon(Click to Download)

XPIL

Summary of Product Characteristics last updated on medicines.ie: 14/4/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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 14 April 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink

Free text change information supplied by the pharmaceutical company

Main changes to Package leaflet:

 

  • Section 1: Moved first paragraph at the end as per EMA recommendation
  • Section 2: cross references to other section has been removed as per EMA recommendation and addition of some other medicines interaction with Jinarc to be in line with SmPC
  • Section 2: addition of advanced kidney disease under the sub section “Warnings and Precautions”
  • Section 2: reorganisation of the sub section “Other medicines and Jinarc” to be in line with the Package Leaflet of Samsca (tolvaptan)

Updated on 14 April 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink

Free text change information supplied by the pharmaceutical company

Main changes to Package leaflet:

 

  • Section 1: Moved first paragraph at the end as per EMA recommendation
  • Section 2: cross references to other section has been removed as per EMA recommendation and addition of some other medicines interaction with Jinarc to be in line with SmPC
  • Section 2: addition of advanced kidney disease under the sub section “Warnings and Precautions”
  • Section 2: reorganisation of the sub section “Other medicines and Jinarc” to be in line with the Package Leaflet of Samsca (tolvaptan)

Updated on 14 April 2020 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Main changes to SmPC:

 

  • Section 4.2:
    • under sub section special population (elderly): age over 50 has been changed to 55 years
    • under sub section renal impairment: additional wording with regard to CKD stage 4 and 5
  • Section 4.4:
    • under sub section idiosyncratic hepatic toxicity, the information of ALT elevation is deleted because this information is moved to section 4.8 as recommended by EMA and a cross reference to section 4.8 is added
    • under sub section dehydration the information on body weight monitoring has been added
    • a new sub heading chronic kidney disease was added for CKD late stage 4 and stage 5
  • Section 4.8: addition/moving of information on ALT elevation from section 4.4 to section 4.8

 

Updated on 1 March 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Updated on 1 March 2019 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.5: addition of the blister in wallet card presentation

Section 8: addition of manufacturing authorisation numbers for the blister in wallet card presentation

Updated on 15 February 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 15 February 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • Update to SmPC section 4.8. addition of gout as undesirable effects under the section “Metabolism and nutrition disorders” with a frequency common

Updated on 3 January 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 3 January 2019 SmPC

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)

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.5: addition of wallet format

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 for wallet

Updated on 24 October 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 24 October 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update on sections 4.4 and 4.8 for the SmPC to add a warning and update the safety information on acute liver failure requiring liver transplantation.

Updated on 31 July 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 31 July 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to SmPC section 4.1 to include extension of Indications CKD stage 1-4.

Updates to SmPC Section 4.8 to add ‘abdominal pain’ to the table of adverse events.

Updates to SmPC section 5.1 (included study results of a phase 3 multi-centre, international, randomized-withdrawal placebo-controlled double blind trial)

Minor additional editorial changes to the SmPC were also carried out

Updated on 27 July 2018 PIL

Reasons for updating

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

Updated on 24 July 2018 SmPC

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 not be renewed (A)

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 Jinarc. The Package Leaflet is updated accordingly.

Updated on 11 July 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

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 Jinarc. The Package Leaflet is updated accordingly.

To replace the wallet card blister with a single blister combining two strengths of tolvaptan tablets.

Updated on 11 July 2018 PIL

Reasons for updating

  • New PIL for new product