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

Section 5.3 Preclinical safety data

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

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.

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.

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”.

Section 6: Content of pack and other information

• Deletion of UK manufacturer and changes in address of local representative (Northern Ireland)

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

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)

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)

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

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

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

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

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.

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

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.

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.