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Neoral 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 18 July 2023

File name

Neoral capsules_REG PIL_PF23-0103_08.06.2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 20 June 2023

File name

Neoral 50mg caps_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

Neoral 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

Neoral 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

Neoral 50mg caps_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

Neoral 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

Neoral 50mg caps_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 16 November 2021

File name

Neoral Soft Capsules_REG PIL_PF21-0206_10.11.2021_clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 31 March 2021

File name

Neoral 50mg Caps REG SPC_PF 20-0199_March 2021_IPHA.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • 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

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

Updated on 31 March 2021

File name

Neoral Soft Capsules_REG PIL_PF 20-0199_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 18 March 2020

File name

Neoral capsulesPF19-0254cleanIPHA.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 18 March 2020

File name

Neoral 50mg Capsules REG SPC_PF19-0254 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 23 December 2019

File name

Neoral REG PIL 46238043 PF XX-XXXX IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 23 January 2019

File name

IPHA_Neoral SGC_46238043_IE_LFT_TBI 6 Jan 2019.pdf

Reasons for updating

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

Updated on 09 August 2018

File name

Neoral 50mg Capsules REG SPC_PF18-0198clean.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 24 September 2015

Reasons for updating

  • New SPC for new product

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

Updated on 24 September 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 clarify the wording in "posology and method of administration".

Updated on 04 March 2015

File name

PIL_8552_673.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 March 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 4.8 has been updated to include the following:

Pain of lower extremities

Isolated cases of pain of lower extremities have been reported in association with ciclosporin. Pain of lower extremities has also been noted as part of Calcineurin-Inhibitor Induced Pain Syndrome (CIPS).

Updated on 04 March 2015

Reasons for updating

  • Change to side-effects

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

Entire SmPC revised following approval of Article 30 referral resulting in harmonisation across all EU countries.

Updated on 17 September 2014

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 07 January 2013

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 26 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 a paragraph about the conversion between oral ciclosporin formulations.

 

Section 4.4 and Section 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 been updated to include a sentence about the use of ciclosporin in liver transplant patients HCV+ and HCV-.

Updated on 06 September 2012

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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 9 - Date of renewal of authorisation
  • 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

Numberous changes have been made to the SmPC following renewal assessment by the Irish Medicines Board.

Updated on 09 December 2008

Reasons for updating

  • Change to appearance of the medicine
  • Change to date of revision

Updated on 04 December 2008

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Change in the capsule marking from the Sandoz triangle to "NVR"

Updated on 17 April 2007

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 14 December 2006

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic 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

Section 4.1 - 4.6 and 5.1, 5.3.  Updates were made to align the National Prescribing Informtion with the Company Core Data Sheet.

Updated on 22 May 2006

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

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 16 May 2005

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 August 2004

Reasons for updating

  • New PIL for medicines.ie