Skip to content
SPC Logo

Adempas 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg film-coated tablets

Last Updated on eMC 25-May-2017 View document  | Merck Sharp & Dohme Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 25-May-2017 and displayed until Current

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:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



-        Section 7 - MARKETING AUTHORISATION HOLDER - updated to reflect the change in the Marketing Authorisation Holder name and address details: Bayer Pharma AG 13342 Berlin Germany to Bayer AG 51368 Leverkusen Germany

Updated on 10-Mar-2017 and displayed until 25-May-2017

Reasons for adding or 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

Date of revision of text on the SPC: 26-Jan-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



·        Section 4.4 – Special Warnings and Precautions for use: Updated to reinforce the existing messages in sections 4.3 and 4.6 with regards to pregnancy.

·        Section 4.5 - Interactions with other medicinal products and other forms of interaction: Iinformation added about interactions of riociguat when administered concomitantly with combined oral contraceptives containing levonorgestrel and ethinyl estradiol to healthy female subjects. The list of CYP isoforms involved in the metabolism of riociguat based on in vitro data has been corrected.

·        Section 5.2 - Pharmacokinetic properties: The list of CYP isoforms involved in the metabolism of riociguat based on in vitro data has been corrected.

·        The Product Information was brought into line with the latest QRD template version 10.0. This affected the SmPC by formatting and slight wording modifications in sections 2, 3, 4.4, 4.6, 6.1 and 8.

Updated on 21-Jul-2016 and displayed until 10-Mar-2017

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • 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: 04-Jul-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



·       Section 4.3 – Contraindications: new contraindication “Patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP)”.

·       Section 5.1 – Pharmacodynamic properties: Clinical efficacy and safety details added from the RISE-IIP study which resulted in the new contraindication.

Updated on 07-Jan-2016 and displayed until 21-Jul-2016

Reasons for adding or updating:

  • Change from individual to joint SPC

Date of revision of text on the SPC: 01-Jul-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

SmPC title changed to combine strengths.

Updated on 02-Sep-2015 and displayed until 07-Jan-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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC: 01-Jul-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:


  • To include information on crushed tablets in sections 4.2 and 5.2
  • Include the phrase "recreational drugs called 'poppers' in sections 4.3 and 4.5
  • Include commas after each ADR in table 1 of section 4.8
  • Deletion of 'mean LS' in table 2 of section 5.1
  • IDT is defined under table 3 of section 5.1 (individual dose titration)

Updated on 21-Oct-2014 and displayed until 02-Sep-2015

Reasons for adding or 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

Date of revision of text on the SPC: 14-Oct-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes are:

·        Section 6.5: ……Pack sizes: 42, 84, 90 or 294 film-coated tablets…..

·        Section 8: addition of the new MA numbers for the 294 pack for each strength

·        Section 10: date of revision added.

 

 

Updated on 07-Apr-2014 and displayed until 21-Oct-2014

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): YES

Company contact details

Merck Sharp & Dohme Limited

Company image
Address

Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU

Fax

+44 (0)1992 479 292

Stock Availability

Call MSD customer services on 01992 452094

Telephone

+44 (0)1992 467 272

Medical Information e-mail

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

riociguat

Legal categories

POM - Prescription Only Medicine

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue