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Sandimmun 50mg Soft Capsules

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Ciclosporin

    *Additional information is available within the SPC or upon request to the company

Updated on 20 June 2023

File name

Sandimmun 50mg capsules_REG SPC_PF22-0134_08.06.2023_clean_IPHA.pdf

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 5.3 - Preclinical safety data

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

Updated on 20 June 2023

File name

Sandimmun capsules_REG PIL_PF22-0134_08.06.2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines

Updated on 11 January 2023

File name

Sandimmun capsules_REG PIL_PF22-0183_09.01.2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 11 January 2023

File name

Sandimmun 50mg capsules_REG SPC_PF22-0183_09.01.2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 28 July 2022

File name

Sandimmun capsules_REG PIL_PF22-0077_26.07.2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 28 July 2022

File name

Sandimmun 50mg capsules_REG SPC_PF22-0077_26.07.2022_clean_IPHA.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

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

Updated on 21 December 2021

File name

Sandimmun SC_REG PIL_PF21-0206_Nov 2021_clean_typo corrected.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 November 2021

File name

Sandimmun SC_REG PIL_PF21-0206_Nov 2021_clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 31 March 2021

File name

Sandimmun 50mg SC_REG SPC_PF 20-0200_March 2021_IPHA.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.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.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 50mg Soft Capsules REG SPC PF19-0253 March 2020 clean.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.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.pdf

Reasons for updating

  • Change of manufacturer
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 09 August 2018

File name

REG_SPC_Sandimmun 50mg Soft Capsules REG SPC_PF18-0228_clean.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

  • New SPC for new product

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

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 - how to report a side effect
  • 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 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 06 December 2006

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Section 4.5 (Interaction with other medicinal products and  other forms of interactions) : Correction of typographical errors

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 4.8 - Undesirable effects
  • 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 4.8 (Undesirable Effects), 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 26 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