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Adempas Film Coated Tablets

*
Pharmacy Only: Prescription

  • Company:

    MSD Ireland (Human Health) Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Riociguat

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

Updated on 20 June 2023

File name

ADEMPAS-H-C-2737-II-0037-SPC-IE-en-May2023.pdf

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 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

Updates to the SPC as a result of a Paediatric indication extension to children less than 18 years weighing at least 50 kg.

Updated on 20 June 2023

File name

QRD-IE-MT-UKNI-ADEMPAS-LFT-II0037_31052023.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • 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 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 16 February 2023

File name

ADEMPAS-H-2737-II-0033G-SPC-IE-enNov2021_LTE-study-results.pdf

Reasons for updating

  • Document format updated

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

Free text change information supplied by the pharmaceutical company

SPC document format updated to html.

Updated on 18 August 2022

File name

QRD-IE-MT-XI-ADEMPAS-LFT-BRX-NIP-Oct2021.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Addition of United Kingdom (Northern Ireland) details to section 4 and section 6 of the PIL.

Updated on 21 December 2021

File name

ADEMPAS-H-2737-II-0033G-SPC-IE-enNov2021.pdf

Reasons for updating

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

Updates to SPC based on the submission of the final clinical study reports of the Phase III long term extension study CHEST-2 and the Phase III long term extension study PATENT-2.

 

Updated on 04 November 2021

File name

ADEMPAS-H-2737-II-0032G-SPC-IE-enOct2021.pdf

Reasons for updating

  • 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 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

Update SPC to contraindicate coadministration of riociguat (Adempas) with other sGC stimulators, and to rectify the Cmax value related to concomitant use with HAART treatment.

 

Updated on 04 November 2021

File name

QRD-IE-MT-ADEMPAS-LFT-II-0032G-Oct2021.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 17 April 2019

File name

Adempas-H-2737-II-028-PIL-en-CRT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 17 April 2019

File name

Adempas-H-2737-II-028-SPC-IE-en-CRT.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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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)

Free text change information supplied by the pharmaceutical company

Information on concomitant use with strong multi pathway CYP / P‑glycoprotein (P-gp) and breast cancer resistance protein (BCRP) inhibitors was added to sections 4.2, 4.4, 4.5

 

Updated on 13 February 2019

File name

ADEMPAS-H-2737-R-0026-PIL-CRT.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 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 13 February 2019

File name

ADEMPAS-H-2737-EN-R-026-SPC-CRT.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 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

Change to section 4.4 (sodium excipient warning); Change to section 4.5 (reference to the recommendation on dose titration)

 

Updated on 13 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 13 March 2018

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

Change to section 10 (change from January 2018 to March 2018)

Updated on 12 March 2018

File name

PIL_16059_482.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 March 2018

Reasons for updating

  • Change to section 6 - date of revision

Updated on 06 March 2018

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Change to section 4.2 (Transitioning between PDE5 inhibitors and riociguat); Change to section 4.5 (Update to reflect on results from the study RESPITE study)

Updated on 05 March 2018

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 14 November 2017

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 5.1 (Update to reflect on results from RISE-IIP, and CHEST-2, PATENT-2 LTE)

Updated on 16 May 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Change to section 7 (MA transfer from Bayer Pharma AG to Bayer AG)

Updated on 15 May 2017

Reasons for updating

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

Updated on 20 March 2017

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 03 March 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.1 - List of excipients
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Change from individual to joint SPC

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

Free text change information supplied by the pharmaceutical company

Change to section 1, 2, 3, 6, 8  (consolidation of different strengths into one SPC) Change to section 4.4, 4.5 (Pregnancy/contraception)

Updated on 25 July 2016

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 22 July 2016

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

SPC Change Details: Riociguat is contraindicated in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias

Updated on 21 July 2016

Reasons for updating

  • Change of contraindications

Updated on 06 January 2016

Reasons for updating

  • Change in co-marketing arrangement

Updated on 09 September 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to dosage and administration
  • Change to MA holder contact details

Updated on 08 September 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • 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



Section 4.2: the following text has been added to this section:

Crushed tablets

For patients who are unable to swallow whole tablets, Adempas tablets may be crushed and mixed

with water or soft foods such as applesauce immediately prior to use and administered orally (see

section 5.2).

 

Section 4.3 has been updated as follows:

-                   Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form  including recreational drugs called ‘poppers’ (see section 4.5).

 

Section 4.5 has been updated as follows:

Pharmacodynamic interactions

Nitrates

In a clinical study the highest dose of Adempas (2.5 mg tablets three times daily) potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) taken 4 and 8 hours after intake. Therefore co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in

any form, including recreational drugs called ‘poppers’, is contraindicated (see section 4.3).

 

Section 5.1: the following changes were made to the subsections:

Patient population with CTEPH post-PEA

Riociguat

(n=52)

Placebo

(n=20)

Baseline (m)

[SD]

360

[78]

374

[72]

Mean change from baseline (m) [SD]

27

[68]

1.8

[73]

Placebo‑ adjusted mean LS- difference (m)

95% CI

27

 

-10 to 63

LS=least squares

 

Adverse Events leading to discontinuation occurred at a similar frequency in both treatment groups

(riociguat individual dose titration (IDT) 1.0-2.5 mg, 2.9%; placebo, 2.3%).

 

Section 5.2: the following text was added:

Bioavailability (AUC and Cmax) is comparable for Adempas administered orally as a crushed tablet

suspended in applesauce or in water compared to a whole tablet (see section 4.2).

 

Updated on 27 November 2014

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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 has been updated to include a 294 tablet pack.

The date of revision has been updated

Updated on 27 November 2014

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size
  • Addition of information on reporting a side effect.

Updated on 01 August 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 01 August 2014

Reasons for updating

  • New PIL for new product