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Opsumit 10mg

*
Pharmacy Only: Prescription

  • Company:

    Janssen Sciences Ireland

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Macitentan

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

EDM Updated on 06 October 2023

File name

Opsumit Risk Management Materials IE - Patient Alert Card.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 06 October 2023

File name

Opsumit - RMM - HCP Cover letter - April 23 Update (2).pdf

Reasons for updating

  • Add New Doc

Updated on 11 January 2023

File name

NI and IE Opsumit SmPC CCDS v14 - clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 11 January 2023

File name

NI and IE Opsumit PIL CCDS v14 - clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 26 July 2022

File name

NI and IE Opsumit SmPC C07 20Jul2022 Clean .pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Updated on 24 May 2022

File name

NI and IE Opsumit SmPC C06 28April2022 Clean.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)

Updated on 24 May 2022

File name

NI and IE Opsumit PIL C05 28April2022 Clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 20 May 2022

File name

ROI and IE Opsumit SmPC C06 28Apr2022 Clean.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)

Updated on 20 May 2022

File name

ROI and IE Opsumit PIL C05 28Apr2022 Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 22 February 2022

File name

ROI and IE Opsumit SmPC C05 23Feb22 Clean EDMS-RIM-665776.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 22 February 2022

File name

ROI and IE Opsumit PIL C04 23Feb22 Clean EDMS-RIM-665780.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 19 May 2021

File name

NI and IE Opsumit SmPC C04 19May21 Clean EDMS-ERI-205905240 V23.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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Updated to add information on drug-drug Interaction with dual moderate inhibitors of CYP3A4 and CYP2C9.

Updated on 19 May 2021

File name

NI and IE Opsumit PIL C03 19May21 Clean EDMS-ERI-205905240 V23.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Updated to add information on drug-drug Interaction with dual moderate inhibitors of CYP3A4 and CYP2C9. Plus change in local representatives

Updated on 18 March 2021

File name

NI and IE Opsumit PIL C02 12March21 Clean EDMS-ERI-205905240 V21.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 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Removal of bottle presentation, change to manufacturer (batch release site), change to local representatives in UK (Norther Ireland).

Updated on 18 March 2021

File name

NI and IE Opsumit SmPC C03 12March21 Clean EDMS-ERI-205905240 V21.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Removal of bottle presentation which was not marketed in Ireland.

Updated on 23 April 2020

File name

Opsumit SmPC C02 CHMP 17 April 2020 clean.pdf

Reasons for updating

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

Section 4.5 updated to introduce results from the Drug-Drug Interaction studies (DDI) with Riociguat and Rosuvastatin. Plus correcting typographical errors across SmPC. 

Updated on 04 March 2020

File name

Opsumit SmPC C01 CHMP 26 Feb 2020 clean.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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

Editorial changes.

Updated on 04 March 2020

File name

Opsumit PIL C01 CHMP 26 Feb 2020 clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Change in manufacturing site responsible for batch release.

EDM Updated on 13 January 2020

File name

Opsumit Cover Letter ROI Jan 2019_.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 03 October 2019

File name

Opsumit Patient Alert Card .pdf

Reasons for updating

  • Add New Doc

Updated on 06 December 2018

File name

EN_Opsumit-H-2697_Notification61(3)_clean_AppV_PI-I-III-21November2018 PIL.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Updated on 05 October 2018

File name

EN_Opsumit-H-2697-renewal+MAH transfer_AppV_PI-I-III_clean_28September2018 PIL.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 05 October 2018

File name

EN_Opsumit-H-2697-renewal+MAH transfer_AppV_PI-I-III_clean_28September2018 SPC.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 4.3 - 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

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

Updated on 18 September 2018

File name

Opsumit 10 mg PIL.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
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 17 September 2018

File name

Opsumit 10 mg SmPC.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
  • Change to section 4.8 - Undesirable effects
  • Improved presentation of SPC

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

Updated on 22 February 2018

File name

PIL_15920_583.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 February 2018

Reasons for updating

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

Updated on 18 January 2017

Reasons for updating

  • New SPC for new product

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

Updated on 18 January 2017

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

$06.3     Shelf life$0$0 $0$054 years.$0

Updated on 17 January 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 October 2016

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Batch address changed.

Updated on 12 October 2016

Reasons for updating

  • Change to name of manufacturer

Updated on 17 March 2016

Reasons for updating

  • 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

Section 6.5

Updated on 09 March 2016

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Shelf life extended from 3 years to 4 years.

Updated on 09 March 2016

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 08 March 2016

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0Macitentan 10 mg once daily did not affectthe pharmacokinetics of an oral contraceptive (norethisterone 1 mg and ethinylestradiol 35 µg).Althoughspecific drug-drug interaction studies with hormonal contraceptives have notbeen conducted, macitentan did not affect theexposure to other CYP3A4 substrates such as sildenafil. Therefore, no reducedefficacy of hormonal contraceptives is expected.$0

Updated on 19 October 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 04 August 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

addition of nasal congestion (common) and oedema/fluidretention (very common) + modification of the clarification paragraph on oedema

Updated on 03 August 2015

Reasons for updating

  • Change to date of revision

Updated on 28 July 2015

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

date of the revision of text

Updated on 24 June 2015

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

addition of nasal congestion (common) and oedema/fluid retention (very common) + modification of the clarification paragraph on oedema

Updated on 23 June 2015

Reasons for updating

  • Change to side-effects

Updated on 28 April 2015

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

$0SmPC Section 4.8:$0$0"Hypersensitivity reactions (e.g. angioedema, pruritus, rash)" with uncommon frequency were added to the tabulated list of adverse reactions under the SOC Immune system disorders.$0

Updated on 22 April 2015

Reasons for updating

  • Change to side-effects

Updated on 25 June 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

$010. DATE OF REVISION OF THE TEXT$0$0 $0$0 May 2014$0$0$0$0

Updated on 20 June 2014

Reasons for updating

  • Change to date of revision

Updated on 07 January 2014

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

None provided

Updated on 03 January 2014

Reasons for updating

  • New PIL for new product