Adempas Film Coated Tablets * Pharmacy Only: Prescription
Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 June 2023
File name
6491ad1626dc5.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
6491ac1728994.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
63ee3cab9c3b9.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
62fdefbd590d6.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_1640085270.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_1636024371.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_1636023565.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_1555509952.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_1555510165.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_1550054353.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_1550054992.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
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
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 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
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
Updated on 01 August 2014
Reasons for updating
- New PIL for new product