Sandimmun 25mg Soft Capsules

Product Information *

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

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 31 March 2021

File name

Sandimmun 25mg SC_REG SPC_PF 20-0200_March 2021_IPHA_1617188017.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 31 March 2021

File name

Sandimmun SC_REG PIL_PF 20-0200_Clean_1617187348.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Updated on 19 March 2020

File name

Sandimmun CapsREG PIL PF 19-0253 March 2020_1584612463.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect

Updated on 19 March 2020

File name

Sandimmun 25mg REG SPC PF 9-0253 March 20202 clean_1584612392.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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)

Updated on 03 January 2020

File name

Sandimmun Soft Capsules REG PIL 46238042 August 2018_IPHA_1578061111.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 23 January 2019

File name

IPHA_sandimmunscapsulesPIL_46238042_IE_REG REV TBI 6 Jan 2019_1548258139.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 09 August 2018

File name

REG_SPC_Sandimmun 25mg Soft Capsules _PF18-0228_clean _1533812106.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 September 2015

File name

PIL_8556_391.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 September 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 25 June 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 4.4 has been revised to update the sorbitol warning
Section 4.8 has been updated to include "pain of lower extremities" as an adverse event of unknown frequency.

Updated on 25 June 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 September 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change due to harmonisation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The entire SmPC has been revised after approval of Article 30 referral during which the text has been harmonised across all EU countries.

Updated on 24 September 2014

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 08 January 2013

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 23 November 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.2 has been updated to include paragraph about conversion between oral forms of ciclosporin.

Sections 4.4 and 4.8 have been updated to specifically describe PML and BK virus nephropathy in the general statement on infections in patients receiving immunosuppressive therapies.

Section 5.1 has beeen updated to include a sentence about the use of ciclosporing in liver transplant patients HCV+ and HCV-. 

Updated on 19 September 2012

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • 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

Numerous changes made to SmPC following licence renewal assessment by the IMB.

Updated on 17 April 2007

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 26 October 2006

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Changes to Section 4.1 (Therapeutic Indications), Section 4.2 (Posology and Method of Administration), Section 4.4 (Special Warnings and Precautions for Use), Section 4.5 (Interactions with other Medicaments and other forms of Interaction,) Section 4.6 (Pregnancy and Lactation), Section 4.9 (Overdose), Section 5.1(Pharmacodynamic Properties), Section 5.2 (Pharmacokinetic Properties) and, Section 5.3 (Preclinical Safety Data) following an update to the company core data sheet

Updated on 23 June 2006

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 May 2005

Reasons for updating

  • Improved electronic presentation

Updated on 26 August 2004

Reasons for updating

  • New PIL for medicines.ie