Vargatef 100mg Soft Capsules *

  • Company:

    Boehringer Ingelheim Limited
  • Status:

    Updated
  • Legal 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

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 13 October 2021

File name

Annex PIL Text 100mg C2569N0042_1634136340.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 04 June 2021

File name

Annex PIL Text 100mg-WS2027_1622807037.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 03 June 2021

File name

V3;all-EU-SPC-17 - medicines.ie_1622732565.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 following sections:

  • Section 4.2 Posology and method of administration: under ‘Method of administration’ the additional statement ‘The capsule should not be opened or crushed (see section 6.6).’ has been included. Note: ‘or crushed’ was included previously but has been moved to the new statement.
  • Section 6.6 Special precautions for disposal: this section has now been renamed ‘Special precautions for disposal and other handling’ and the following statement included – ‘In the event of coming in contact with the content of the capsule, hands should be washed off immediately with plenty of water (see section 4.2).’
  • Section 10 Date of revision of the SmPC has also been updated.

Updated on 06 April 2021

File name

Annex PIL text 100 mg - II-0038_1617723366.pdf

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 06 April 2021

File name

V3-ALL-EU-SPC-16 - medicines.ie_1617719126.pdf

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: To include information with regards to Nephrotic range proteinuria.
  • Section 4.8: To include a new ADR ‘Proteinuria’ as a side effect (frequency common).
  • Section 10: Date of revision has been updated.

Updated on 10 March 2021

File name

Annex PIL text 100 mg - II-0035 G_1615412176.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 09 March 2021

File name

V3-EU-SPC-15 - medicines.ie_1615307477.pdf

Reasons for updating

  • 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 - 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 4.6: To include information with regards to fertility, pregnancy and lactation.
  • Section 4.5 and 5.2: To include information on concomitant treatment with oral hormonal contraceptives.
  • Section 4.8: To include AE reporting details for Northern Ireland. 
  • Section 10: Date of revision has been updated.

Updated on 29 September 2020

File name

Annex PIL text 100 mg - IG-1293_1601398517.pdf

Reasons for updating

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

Updated on 11 August 2020

File name

Annex PIL text 100 mg - PSUSA 201910-replacement-11.08.2020_1597163250.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 06 August 2020

File name

Annex PIL text 100 mg - PSUSA 201910_1596728001.pdf

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 06 August 2020

File name

V3-All-SPC-13-medicines.ie_1596721128.pdf

Reasons for updating

  • 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

Sections 4.4 and 10 have been updated

Updated on 21 January 2020

File name

Annex PIL text 100 mg - WS 1722_1579609755.pdf

Reasons for updating

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

Updated on 20 January 2020

File name

V3-All-SPC-12_1579531209.pdf

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: Addition of new ADRs ‘Headache’ (frequency common) & ‘Alopecia’ (frequency very common)
  • Section 10: Date of revision has been updated to 12/2019

Updated on 11 September 2019

File name

Annex PIL text 100 mg_1568195246.pdf

Reasons for updating

  • 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 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 10 September 2019

File name

V3-all-spc-11_1568131238.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - 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 6.1 - List of excipients
  • 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

·    Removal of black triangle

·     Sections 2, 3, 4.2, 4.3, 4.5, 4.6, 4.8, 5.1, 5.2, 6.1, 6.5, 8 & 9: minor administrative/editorial changes, including addition of the latest renewal approval date

·    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 10: Date of revision has been updated to 08/2019 

Updated on 16 August 2019

File name

Annex PIL text 100 mg - PSUSA_1565948326.pdf

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 16 August 2019

File name

V3-all-spc-10_1565941513.pdf

Reasons for updating

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

Updated on 09 August 2018

File name

Vargatef 100 mg_1533821072.pdf

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 09 August 2018

File name

V3-all-spc-9_1533819691.pdf

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: Update regarding gastrointestinal perforations and Renal function.
  • Section 4.8: Addition of ‘Myocardial Infarction´ & ‘Renal Failure’ as ADRs.
  • Section 4.8: Addition of ‘Pruritus´ as an ADR.
  • Section 10: Date of revision of the text has been aligned to 07/2018

Updated on 11 June 2018

File name

vargetef-100mg.pdf

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 05 June 2018

File name

V3-all-spc-8.docx

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 24 November 2017

Reasons for updating

  • Change to other sources of information section
  • Improved presentation of PIL

Updated on 24 November 2017

File name

PIL_16226_392.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 October 2017

Reasons for updating

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

Updated on 17 October 2017

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: Updated to amend the current warning on hepatic function to include drug liver induced injury associated with nintedanib administration and to include low body weight, Asian origin, female sex and age as factors of increased risk of liver enzymes elevations.

·        Section 4.8: Updated to add ‘weight decreased’ and ‘drug-induced liver injury’ (DILI) as new adverse drug reactions.

·        Section 5.2:  Update to amend the current information related to the mean exposure to nintedanib in the ‘Race’ sub-section.

·        Section 10: Date of revision has also been updated to 09/2017.

Updated on 17 October 2017

Reasons for updating

  • New SPC for new product

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

Updated on 31 August 2017

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

·        Sections 4.4: Following wording update in the ‘Gastrointestinal disorders’ subsection;

Ø  Information regarding post-marketing serious cases of diarrhoea has been added.

Ø  Information regarding interruption, dose reduction and discontinuation of Vargatef therapy may be required in an event of dehydration, has been added.


·        Sections 4.4: Following wording update in the ‘Haemorrhage’ subsection;

Ø  Information regarding post-marketing serious and non-serious events of bleeding has been added.


·        Sections 4.8: Information in the ‘Bleeding’ subsection has been updated in line with the wording in section 4.4. A cross-reference to section 4.4 has also been added for the side effect ‘Bleeding’.


Section 10: Date of revision of the text has also been aligned to 08/2017 with the date of Commission decision, which was 14/08/2017.

Updated on 31 August 2017

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 30 March 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 09 March 2017

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) has been updated to include Pancreatitis as a side effect with frequency uncommon.
Section 10, date of revision of the text has been aligned with date of commission decision (23Feb17).

Updated on 07 March 2017

Reasons for updating

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

Updated on 13 January 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 21 December 2016

Reasons for updating

  • 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

Updated on 20 December 2016

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • 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

The following sections have been updated:

- Section 3 3 pharmaceutical form changed to include (capsule)

- Section 4.8 Undesirable effects updated in include Thrombocytopenia plus typographical changes including Malta website address aligned with Appendix V (‘Website:’ added)

- Section 10 Date of revision of the text updated to reflect PO date: 10Nov16

Updated on 19 October 2016

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 5.3 - 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

Sections 4.2 (Posology and method of administration) and 4.4 (Special warnings and precautions for use) of the SPC have been updated to include revised information  for patients with hepatic impairment.

A typographical correction has been made in section 5.3 (Preclinical safety data).

Section 10 the date of revision has been amended.

Updated on 14 September 2016

Reasons for updating

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

Updated on 30 August 2016

Reasons for updating

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

Sections 4.4 and 4.8: Additional common side effect added under the class of Hepatobiliary disorders – ‘Gamma-glutamyl transferase increased’

Section 4.8: Malta Adverse Event reporting address updated to align with QRD template, Appendix V

Section 10: revision date has been revised in line with the commission decision date of the variation (18 August 2016)

Updated on 29 February 2016

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • 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 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 5.3 change from

In rats, embryofoetal lethality and teratogenic effects were observed at exposure levels below human exposure, at the maximum recommended human dose (MRHD) of 250 mg b.i.d.. Effects on the development of the axial skeleton and on the development of the great arteries were also noted at subtherapeutic exposure levels.

to

In rats, embryofoetal lethality and teratogenic effects were observed at exposure levels below human exposure, at the maximum recommended human dose (MRHD) of 200 mg b.i.d.. Effects on the development of the axial skeleton and on the development of the great arteries were also noted at subtherapeutic exposure levels.

Section 10 - date of revision amended.

Updated on 29 April 2015

Reasons for updating

  • Improved electronic presentation

Updated on 24 March 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 18 March 2015

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of 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

Section 5.1 Pharmacodynamic Properties

The ATC code of L01XE31 has been added to this section.  The previous text of not yet assigned has been deleted.

 

Section 9 Date of  First Authorisation/Renewal of the Authorisation

The text Date of first authorisation: has been added to this section.

 

Section 10 Date of Revision of the Text

The date of March 2015 has been added to this section.

Updated on 03 February 2015

Reasons for updating

  • New PIL for new product

Updated on 23 January 2015

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