Adempas Film Coated Tablets

  • Name:

    Adempas Film Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Riociguat

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/04/19

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Summary of Product Characteristics last updated on medicines.ie: 17/4/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Adempas Film Coated Tablets Active Ingredients Riociguat
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Medicine Name Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension Active Ingredients Losartan potassium
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Medicine Name Elocon Ointment Active Ingredients Mometasone Furoate
Medicine Name Elocon Scalp Lotion Active Ingredients Mometasone Furoate
Medicine Name EMEND 125 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80 mg hard capsules Active Ingredients Aprepitant
Medicine Name EMEND 80mg, 125mg hard Capsules Active Ingredients Aprepitant
Medicine Name Esmeron Active Ingredients Rocuronium Bromide
Medicine Name EZETROL 10 mg Tablets Active Ingredients ezetimibe
Medicine Name FOSAMAX Once Weekly 70 mg Tablets Active Ingredients Alendronate Sodium Trihydrate
Medicine Name FOSAVANCE Active Ingredients Alendronate Sodium Trihydrate, Colecalciferol (Vitamin D3)
Medicine Name GARDASIL Active Ingredients human papillomavirus vaccine
1 - 0 of 84 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 17 April 2019 PIL

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 SmPC

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 PIL

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 SmPC

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 SmPC
  • 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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 March 2018 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 March 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 6 March 2018 SmPC

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 5 March 2018 PIL

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 SmPC

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 SmPC

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 PIL

Reasons for updating

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

Updated on 20 March 2017 PIL

Reasons for updating

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

Updated on 3 March 2017 SmPC

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 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 22 July 2016 SmPC

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 PIL

Reasons for updating

  • Change of contraindications

Updated on 6 January 2016 PIL

Reasons for updating

  • Change in co-marketing arrangement

Updated on 9 September 2015 PIL

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 8 September 2015 SmPC

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 SmPC

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 PIL

Reasons for updating

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

Updated on 1 August 2014 SmPC

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 1 August 2014 PIL

Reasons for updating

  • New PIL for new product