TAGRISSO 40 mg and 80mg film-coated tablets

  • Name:

    TAGRISSO 40 mg and 80mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Osimertinib mesylate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/04/20

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Summary of Product Characteristics last updated on medicines.ie: 8/4/2020
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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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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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 8 April 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

4.8 Undesirable effects

 Erythema multiforme added as an uncommon side effect to Table 2. Adverse reactions reported in FLAURA and AURA studies

Footnote added to Table 2 about incidence of erythema multiforme

10. DATE OF REVISION OF THE TEXT

Updated to 2 April 2020

Updated on 8 April 2020 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

(Inserted Text; Deleted Text)

4. Possible side effects

….

Tell your doctor straight away if you notice the following serious side effects:

…..

  • Stevens-Johnson syndrome, which can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and be preceded by fever and flu-like symptoms. This side effect is rare: it may affect up to 1 in 1000 people. See also Section 2.
  • Target lesions, which are skin reactions that look like rings (suggestive of Erythema multiforme). This side effect is uncommon: it may affect up to 1 in 100 people.

This leaflet was last revised in September 2019 April 2020.

Updated on 18 March 2020 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 8 - Marketing authorisation number(s)
  • 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 significant changes were made:

Section 5.1 Pharmacodynamic properties

Overall survival (OS) data from interim analysis replaced with final data in text and in Table  3.

% patients alive – 24 and 36 months data added, 18-month % in Tagrisso arm corrected.

Kaplan-Meyer OS curve added as Figure 2.

8. MARKETING AUTHORISATION NUMBER

Description added to authorisation numbers, as per below in green (Section 8), for clarity and to minimise risk of errors.

EU/1/16/1086/001 40 mg 30 film-coated tablets

EU/1/16/1086/002 80 mg 30 film-coated tablets

EU/1/16/1086/003 40 mg 28 film-coated tablets

EU/1/16/1086/004 80 mg 28 film-coated tablets

10 DATE OF REVISION OF THE TEXT

Updated to 12 March 2020.

Updated on 6 November 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

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 Posology and method of administration: Updated Renal Impairment section with information based on clinical studies and population PK analysis. 

Section 5.2 Pharmacokinetic properties: Addition of data from renal impairment study.

Updated on 25 September 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Under 'other side effects' the word 'pain' was included for skin and nail problems.

'Skin and nail problems - signs may include pain'

Updated on 25 September 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

'Onychalgia' added under Table 2 section h, as a possible skin and subcutanous tissue disorder adverse reaction.

Updated on 30 August 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 - manufacturer
  • Change to section 6 - date of revision

Updated on 29 August 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 4.8 - 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

Section 4.2 Posology and method of administration

Change in dose modification after Interstitial Lung Disease (ILD) with cross-reference to Section 4.4:

Table 1 – Permanently dDiscontinue TAGRISSO (see Section 4.4)
 

Section 4.4 Warnings and precautions
ILD

Last paragraph revised to allow possible reintroduction of TAGRISSO after ILD after careful consideration of the individual patient’s benefit-risk (changed from permanent discontinuation)

 Addition of Stevens-Johnson syndrome:

Stevens-Johnson syndrome

Case reports of Stevens-Johnson syndrome (SJS) have been reported rarely in association with TAGRISSO treatment. Before initiating treatment, patients should be advised of signs and symptoms of SJS. If signs and symptoms suggestive of SJS appear, TAGRISSO should be interrupted or discontinued immediately.

 Changes in cardiac contractility:

Deletion of one sentence: Based on the available clinical trial data, it is not possible to determine a causal relationship between effects on changes in cardiac contractility and TAGRISSO.
 

Section 4.8 Undesirable effects

SJS added as a rare event in Table 2

Removal of UK adverse event reporting details and update to HPRA reporting details
 

Section 10 Date of revision of the text

Revision date updated to 26th August 2019

Updated on 10 September 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 21 June 2018 SmPC

Reasons for updating

  • 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)

Updated on 19 June 2018 SmPC

Reasons for updating

  • 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)

Updated on 19 June 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 15 June 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 15 June 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 15 September 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 15 September 2017 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

In section 4.8, UK ADR reporting details have been updated.

Updated on 14 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 September 2017 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 6 September 2017 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 September 2017 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided