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MSD Ireland (Human Health) Limited

Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 14/11/2017
SPC Adempas Film Coated Tablets

When a pharmaceutical company changes an SPC or PIL, 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 14/11/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12-Oct-2017
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 16/05/2017 and displayed until 14/11/2017
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02-May-2017
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 03/03/2017 and displayed until 16/05/2017
Reasons for adding or 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
Date of revision of text on the SPC:   22-Feb-2017
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 22/07/2016 and displayed until 03/03/2017
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   04-Jul-2016
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 08/09/2015 and displayed until 22/07/2016
Reasons for adding or 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
Date of revision of text on the SPC:   23-Jul-2015
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 27/11/2014 and displayed until 08/09/2015
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   14-Oct-2014
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 01/08/2014 and displayed until 27/11/2014
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Riociguat