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IRESSA 250 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    AstraZeneca Pharmaceuticals (Ireland) DAC

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    gefitinib

    *Additional information is available within the SPC or upon request to the company

Updated on 26 January 2021

File name

20210114 SPC IE MT Iressa Film-coated Tablets 250mg PPES HFS ONC 21 0002_1611699992.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

 

4.8       Undesirable effects

[..]

Tabulated list of adverse reactions

[..]

Skin and subcutaneous tissue disorders

Very common

Skin reactions, mainly a mild or moderate (CTC grade 1 or 2) pustular rash, sometimes itchy with dry skin, including skin fissures, on an erythematous base

Common

Nail disorder

Alopecia

Allergic reactions (1.1%), including

angioedema and urticaria

Uncommon

Palmar-plantar erythrodysaesthesia syndrome

 

[..]

[..]

 

[..]

8.       MARKETING AUTHORISATION NUMBER(S)

 

EU/1/09/526/001 perforated blister

EU/1/09/526/002 non perforated blister

Updated on 26 January 2021

File name

20210114 Package Leaflet IE MT Iressa Film-coated Tablets 250mg PPES HFS ONC 21 0003_1611699825.pdf

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

2. What you need to know before you take IRESSA

[..]

Driving and using machines

If you feel weak whilst taking this medicine, take care driving or using tools or machines.

You may feel weak while taking treatment with Iressa. If this happens, do not drive or use any tools or machines.

 

[..]

 

4.         Possible side effects

[..]

Uncommon: may affect up to 1 in 100 people

[..]

  • Skin reaction on the palms of the hands and soles of the feet including tingling, numbness, pain, swelling or reddening (known as palmar-plantar erythrodysaesthesia syndrome or hand and foot syndrome).

Updated on 31 July 2019

File name

2018-04-23_cSmPC_Iressa_250mg_Tabs_UIM_ONC_18_0010_1564563424.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 26 April 2019

File name

20190327-package leaflet-uim-iressa-tablets-250mg-brexit update-ONC 19 0002_1556274598.pdf

Reasons for updating

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

Updated on 01 May 2018

File name

2018-04-23_cSmPC_Iressa_250mg_Tabs_UIM_ONC_18_0010.docx

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 01 May 2018

File name

2018-04-23 cPIL Iressa 250mg Tabs UIM ONC 18 0011.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 02 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 02 May 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Free text change information supplied by the pharmaceutical company

In section 4.1, the text 'as monotherapy' has been added to the indication wording.

Updated on 07 February 2017

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 4.4 - Special warnings and precautions for use
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

Section 2- Editorial & formatting updates

Section 3- Editorial & formatting updates

Section 4.2- QRD & editorial updates

Section 4.3- Editorial & formatting updates

Section 4.4- Editorial & formatting updates

Section 4.6- Editorial & formatting updates

Section 4.7- Editorial & formatting updates

Section 4.8- Editorial & formatting updates

Section 5.1- Addition of ‘resistance data’ & formatting updates

Section 5.2- Editorial & formatting updates

Section 8- Addition of new MA number (EU/1/09/526/002)

Section 10- Update to Date of Revision

Updated on 05 October 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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 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

Section 2- QRD updates

Section 4.2- Grammatical updates

Section 4.8- Change of frequency from uncommon to common for allergic reactions including angioedema and urticarial

Section 5.1- Grammatical updates

Section 5.2- Grammatical updates

Section 5.3- Addition of text regarding causal association between QT prolongation and gefitinib

Section 7- Grammatical updates

Section 10- Update to Date of Revision


please note this is a resubmission of a SmPC as the initial SmPC had a typographical error

Updated on 30 September 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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 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

Section 2- QRD updates

Section 4.2- Grammatical updates

Section 4.8- Change of frequency from uncommon to common for allergic reactions including angioedema and urticarial

Section 5.1- Grammatical updates

Section 5.2- Grammatical updates

Section 5.3- Addition of text regarding causal association between QT prolongation and gefitinib

Section 7- Grammatical updates

Section 10- Update to Date of Revision

Updated on 29 September 2016

File name

PIL_14344_40.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 September 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 08 May 2015

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

Section 4.8 reporting side effects- MT address details have been amended

Updated on 05 May 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 03 October 2014

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 5.1 - 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

- Section 4.4 addition of ctDNA

Section 4.8 – update to HPRA AE address

Section 5.1 – information relating to ctDNA

Section 10 – date of revision

Updated on 26 September 2014

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 06 May 2014

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 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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 4.2          Editorial changes (Iressa to gefitinib), Addition of “patients” to heading “Elderly patients”, clarification that tablets taken orally.

Section 4.4          Editorial changes (Iressa to gefitinib).

Section 4.5          Editorial changes (Iressa to gefitinib).

Section 4.6          Fertility section moved and renamed “Women of childbearing potential”, Editorial changes (Iressa to gefitinib).

Section 4.7          Deletion of statement that Iressa has no or negligible influence on the ability to drive and use machinery.

Section 4.8          Addition of subheadings, capitalisation of side effect, editorial changes including to description of adverse reactions, amendment of IMB ADR reporting address in line with QRD template.

Section 5.1          Addition of antineoplastic agents to Pharmacotherapeutic group, editorial amendment to subheading

Section 6.1          Minor editorial amendments

Section 6.4          Removal of storage conditions cross reference.

Section 6.5          Editorial amendment to spell number 3.

Section 9              Addition of Renewal date

Section 10           Update date of revision

Updated on 01 May 2014

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 21 August 2013

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 5.2 - Pharmacokinetic properties
  • 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 4.1 – Update cross-reference to remove the heading in line with the QRD

Section 4.2 – Update cross-reference to remove the headings in line with the QRD

Section 4.3 – Update cross-reference to remove the heading in line with the QRD

Section 4.4 – Update cross-reference to remove the headings in line with the QRD

Section 4.5 – Update cross-reference to remove the headings in line with the QRD

Section 4.6 – Update cross-reference to remove the headings in line with the QRD

Section 5.2 – Update cross-reference to remove the headings in line with the QRD

Section 6.5 – Update statement regarding perforated/non-perforated blisters.

Updated on 19 August 2013

Reasons for updating

  • Correction of spelling/typing errors

Updated on 09 July 2013

Reasons for updating

  • 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 4.6 – Position of fertility statement moved.

Section 4.8 – Addition of “Reporting of suspected adverse reactions” statement including national reporting system details.

Section 5.1 – Addition of IFUM study details.

Section 5.2 – Rename “Metabolism” paragraph as “Biotransformation”.

Section 10 – Update “Date of revision”

Updated on 05 July 2013

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 16 May 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 2

 

Updated to reflect new European-standard wording.

Section 4.3

 

Updated to reflect new European-standard wording.

 

Section 4.4

 

Updated to reflect class-effect warning concerning Keratitis.

 

Section 4.6

 

Updated to reflect new European-standard wording.

 

Section 4.8

 

Inclusion of keratitis, in line with change to section 4.4.

 

Section 6.4

 

Updated to reflect new European-standard wording.

 

Section 6.6

 

Updated to reflect new European-standard wording.

 

Section 9

 

Updated to reflect new European-standard wording.

 

Section 10

 

Approval Date amended to 20th April 2012.

Updated on 16 May 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Improved electronic presentation

Updated on 08 August 2011

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

Section 5.1 - addition of informatin relating to IPASS

Section 10 Date of revision changed to 2nd August 2011

Updated on 05 August 2011

Reasons for updating

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

Updated on 21 January 2011

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

Updated information:

Paediatric  population

The safety and efficacy of IRESSA in children and adolescents aged less than 18 years have not been established. There is no relevant use of IRESSA in the paediatric population in the indication of NSCLC.

 

Section 4.4

Changed text first paragraph under heading

‘Hepatotoxicity and liver impairment’

 

New additional text in last paragraph of section 4.4

Gastrointestinal perforation has been reported in patients taking IRESSA. In most cases this is associated with other known risk factors, including concomitant medications such as steroids or NSAIDs, underlying history of GI ulceration, age, smoking or bowel metastases at sites of perforation.

 

Section 4.6

Additional text at start of section: Women of childbearing potential

Women of childbearing potential must be advised not to get pregnant during therapy.

 

Section 4.8

Additional information in table 1:

Gastrointestinal disorders – Uncommon - gastrointestinal perforation

 

Hepatobiliary disorders – Uncommon – Hepatitis includes a footnote ***

 

Skin and subcutaneous tissue disorders – Very common - .....’ including skin fissures,’.....

Skin and subcutaneous tissue disorders - Rare - Cutaneous vasculitis

 

Renal and urinary disorders – Common – Cystitis

Renal and urinary disorders - Rare - Haemorrhagic cystitis


Additional footnote under Table 1

***This includes isolated reports of hepatic failure which in some cases led to fatal outcomes.


Section 4.9

Additional text in section.


Section 10

Change of revision date – 30 November 2010

Updated on 17 January 2011

Reasons for updating

  • Change to side-effects

Updated on 15 October 2009

Reasons for updating

  • SPC re-instated

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

Free text change information supplied by the pharmaceutical company

SmPC reinstated.

Updated on 09 October 2009

Reasons for updating

  • PIL re-instated

Updated on 31 July 2009

Reasons for updating

  • New SPC for new product
  • SPC retired pending re-submission

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 24 July 2009

Reasons for updating

  • New PIL for new product
  • PIL retired pending re-submission