Ofev 150 mg soft capsules

  • Name:

    Ofev 150 mg soft capsules

  • Company:
    info
  • Active Ingredients:

    Nintedanib esilate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/05/20

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Summary of Product Characteristics last updated on medicines.ie: 4/5/2020

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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1 - 0 of 48 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 4 May 2020 PIL

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 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 4 May 2020 SmPC

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 4.8 - 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

Section 4.1: New Indication - Treatment of Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) in adults.

Section 4.2: Consequential changes related to new Indication & other editorial changes.

Section 4.3: Addition of ‘Pregnancy’ as a contraindication with cross-reference to section 4.6.

Section 4.4: Editorial updates and clarifications throughout section 4.4 to the information related to the INPULSIS trial + Addition of information throughout section 4.4 related to the SENSCIS trial + addition of a warning related to ‘Pulmonary hypertension’ & other editorial changes.

Section 4.5: Addition of information regarding co-administration of nintedanib with bosentan.

Section 4.6: Update to information related to Women of childbearing potential/Contraception + Consequential update to section 4.3 regarding the information related to pregnancy.

Section 4.8: Addition of side-effects and frequency related to the new indication (SSc-ILD) + Editorial updates and clarifications to the information related to the INPULSIS trial + Addition of information related to the SENSCIS trial & Other editorial changes.

Section 5.1: Update to information in the sub sections ‘Mechanism of action’ and ‘Pharmacodynamic effects’ + Addition of information related to the new indication (SSc-ILD) & Other editorial changes.

Section 5.2: Consequential editorial updates related to the new indication (SSc-ILD) + Addition of information related to Concomitant treatment with bosentan & Other editorial changes.

Section 10: Date of revision has been updated to 17 April 2020 to align with Commission decision date.

 

 

Updated on 20 January 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 January 2020 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 4.8 of the SmPC has been updated to include new ADRs headache and alopecia 

A further editorial change has been made to section 4.8

Section 10 date of revision has been updated 

Updated on 16 October 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Removal of Black Inverted Triangle

Updated on 15 October 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • 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

  • Deletion of the black triangle warning.
  • Section 2, 3, 6.5, 8: Formatting/ editorial changes to include subheadings for Ofev 100mg and Ofev 150mg.
  • Section 4.1, 4.4, 4.8, 5.1: Minor editorial changes to the text.
  • Section 9: Addition of date of last renewal as 23/09/19.
  • Section 10: Date of revision has been updated to 23/09/2019.

Updated on 10 September 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 10 September 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 4.4 & 4.8: To add a warning and an ADR regarding ‘aneurysms and artery dissections’ (PRAC recommendation to update the product information of respective EU Marketing Authorisation Holders for the class of VEGF inhibitors)

·         Section 4.8: To add ‘colitis’ as an ADR

·         Section 4.8: section 4.8 has also been updated with the revised Irish AE reporting information

·         Section 10: Date of revision has been updated to 04 September 2019 

Updated on 29 November 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 November 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

The SmPC has been updated in section 4.8 to add Myocardial infarction as a side effect with a frequency of uncommon.

Section 10 date has been updated.

Updated on 10 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 9 August 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

The SmPC has been updated in section 4.4 addition of new text with regards to Renal function and section 4.8 addition of new ADRs: rash (frequency common); pruritus (frequency uncommon); renal failure (frequency not known) following the approval of the PSUSA/00010319/201710.  Date of revision has been updated.

Updated on 11 July 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 5 July 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 11 June 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 8 June 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 20 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 September 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 29 August 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 August 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.4 - Special warnings and precautions of the SPC has been updated to include further information under sub-section ‘hepatic function’.  Section 4.8 – Undesirable effects of the SPC has been updated to revise DILI frequency from ‘not known’ to ‘uncommon’.  Section 5.2 - Pharmacokinetic properties of the SPC has been updated to revise the information under sub-section ‘Race’. Section 10 of the SPC has also been revised to include the approval date

Updated on 10 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 8 August 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.4 (Special warnings and precautions) of the SPC has been revised to amend the current warnings regarding diarrhoea, haemorrhage and gastrointestinal perforations. Section 4.8 (Undesirable effects) of the SPC has been updated to add dehydration with an ‘uncommon’ frequency and to add a cross reference to section 4.4 for Bleeding. Section 4.8 has also been updated with regards to contact information for reporting adverse reactions.  Section 10 of the SPC has also been revised to include the approval date

Updated on 16 February 2017 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Improved presentation of PIL

Updated on 31 January 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 30 January 2017 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 3 (Pharmaceutical form) has been updated to include the term capsule.

Section 4.4 (Special warnings and precautions for use) has been updated to amend the current warning on hepatic function to add that administration of nintedanib was also associated with drug-induced liver injury.

Section 4.8 (Undesirable effects) has been updated to add:
-
drug-induced liver injury as a new adverse drug reaction with a ‘not known’ frequency
-
thrombocytopenia as a new adverse drug reaction with a frequency 'uncommon' under the System Organ Class  ‘Blood and lymphatic system disorders’.

Section 10 (Date of revision of the text) has been updated.

Updated on 28 September 2016 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 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 and section 4.4 Updated to include revised dose recommendations for pateints with mild hepatic impairment (Child Pugh A).

Section 10 - date of revision amended.

Updated on 16 September 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 23 August 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 4.8 (Undesirable effects) of the SPC has been updated to add bleeding with a frequency common and to delete epistaxis under the ‘Vascular disorders’ System Organ Class (SOC) and to add pancreatitis with a frequency uncommon under the ‘Gastrointestinal Disorders’ SOC.  The wording for the description of the source of information in Table 1 – Summary of ADRs has been revised to include ‘or from the postmarketing period’.  Section 10 of the SPC has also been revised.

Updated on 18 March 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 29 February 2016 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 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

Changes made to sections 1, 2, 3, 6.5 and section 8 resulting from the 100 mg and 150 mg SPCs being combined into a single consolidated SPC.

Sections 4.2, 4.4 and 5.2 - changes have been introduced regarding hepatic function and impairment.

Section 9 information expressed more clearly.

Section 10 - date of revision amended.

Updated on 5 February 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 1 February 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

The update affects sections 4.4 and 4.8 of the SPC. Section 10 has been updated accordingly.

Updated on 14 April 2015 SmPC

Reasons for updating

  • Addition of legal category

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

Free text change information supplied by the pharmaceutical company

Legal category changed to restricted medical prescription

Updated on 30 March 2015 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 30 March 2015 PIL

Reasons for updating

  • New PIL for new product