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

Product Information *

  • Company:

    Otsuka Pharmaceutical UK Ltd.
  • Status:

    No Recent Update
  • Active Ingredients :

    This medicinal product is subject to additional monitoring.

    *Additional information is available upon request

  • Legal Category:

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

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 26 May 2021

File name

Jinarc-II-0029_RMP updates_9Apr2021_Ireland SmPC_1622048561.pdf

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Section 5.3 Preclinical safety data

Updated on 30 April 2021

File name

Jinarc-II-0031_CSR 211_25Mar2021_Ireland PIL_1619789150.pdf

Reasons for updating

  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Only editorial updates have been made to the Package Leaflet (PL).

Updated on 30 April 2021

File name

Jinarc-II-0031_CSR 211_25Mar2021_Ireland SmPC_1619788653.pdf

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

The Summary of Product Characteristics (SmPC) has been updated as follows:

 

Update of information in Section 4.2 Posology and method of administration and 4.4 Special warnings and precautions for use of the SmPC. The update is based on the data from the clinical trial

156-13-211, A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease.

 

The new wording reads:

Section 4.2

Limited data are available for patients with CKD late stage 4 (eGFR < 25 mL/min/1.73 m2). No data are available for patients with CKD stage 5.

 

Section 4.4

Limited safety and efficacy data are available for Jinarc in patients with CKD late stage 4 (eGFR< 25 mL/min/1.73 m2). There are no data in patients with CKD stage 5.

Updated on 13 April 2021

File name

Jinarc-PSUR 18_EMEA_H_C_PSUSA_00010395_202005 Ireland PIL_1618335883.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 4 (Possible side effects) have been updated with the following common side effects: taste changes, fainting, dry skin, hives, joint pain, muscle pain and weight gain.

Updated on 13 April 2021

File name

Jinarc-PSUR 18_EMEA_H_C_PSUSA_00010395_202005 Ireland SmPC_1618335369.pdf

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 of the section 4.8 in the SmPC (Undesirable effects) to add the following adverse reactions: dysgeusia, syncope, dry skin, urticaria, arthralgia, myalgia and weight increased, each of them with a frequency “common”.

Updated on 16 March 2021

File name

Jinarc-UK site deletion_EMEA_H_C_002788_IA_0032 Ireland PIL_1615910075.pdf

Reasons for updating

  • Change to section 6 - manufacturer

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 (Northern Ireland)

Updated on 16 March 2021

File name

Jinarc-UK site deletion_EMEA_H_C_002788_IA_0032 Ireland SmPC_1615909513.pdf

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

No changes to SmPC content; however, minor formatting changes to the SmPC carried out

Updated on 14 April 2020

File name

Jinarc- Renewal EMEA_H_C_002788_R_0027 Ireland PIL_1586863522.pdf

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

File name

Jinarc- Renewal EMEA_H_C_002788_R_0027 Ireland PIL_1586862947.pdf

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

File name

Jinarc- Renewal EMEA_H_C_002788_R_0027 Ireland SmPC_1586862189.pdf

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 01 March 2019

File name

Jinarc PIL IE Gout variation consolidated_final_1551437987.pdf

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 01 March 2019

File name

Jinarc SmPC IE Gout variation consolidated_final_1551437437.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 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

File name

Jinarc PIL Gout variation - IE final_1550231198.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 15 February 2019

File name

Jinarc SmPC - Gout variation IE final_1550231638.pdf

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 03 January 2019

File name

Jinarc PIL MAH + Wallet Blister FINAL_1546526212.pdf

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 03 January 2019

File name

Jinarc SmPC MAH + Wallet FINAL_1546525223.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)

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

File name

Jinarc - PIL liver toxicity variation -medicines.ie_1540384456.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 24 October 2018

File name

SmPC for Jinarc - liver tox - medicines.ie_1540382380.pdf

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

File name

JINARC PIL - FINAL_1533038873.pdf

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

File name

JINARC SmPC - Final_1533034861.pdf

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

File name

Jinarc 13,30,45,60,90mg tab PIL June2018.pdf

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

File name

Jinarc 15,30,45,60,90mg tab SmPCJune2018.pdf

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

File name

Jinarc 15,30,45,60,90mg tab SmPCJune2018.docx

Reasons for updating

  • New SPC 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

File name

Jinarc 15,30,45,60,90mg tab PIL June2018.pdf

Reasons for updating

  • New PIL for new product