IRESSA 250 mg film-coated tablets
- Name:
IRESSA 250 mg film-coated tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/04/19
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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 31 July 2019
Reasons for updating
- File format updated to PDF
Updated on 26 April 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 1 May 2018
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 1 May 2018 PIL
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 2 May 2017
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 2 May 2017 SPC
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
Updated on 7 February 2017 SPC
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 5 October 2016 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 29 September 2016 PIL
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 8 May 2015 SPC
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
Updated on 5 May 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 3 October 2014 SPC
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 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 6 May 2014 SPC
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 1 May 2014 PIL
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 SPC
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 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 9 July 2013 SPC
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 5 July 2013 PIL
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 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Improved electronic presentation
Updated on 8 August 2011 SPC
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 10 Date of revision changed to 2nd August 2011
Updated on 5 August 2011 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 21 January 2011 SPC
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 PIL
Reasons for updating
- Change to side-effects
Updated on 15 October 2009 SPC
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
Updated on 9 October 2009 PIL
Reasons for updating
- PIL re-instated
Updated on 31 July 2009 SPC
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
Updated on 24 July 2009 PIL
Reasons for updating
- New PIL for new product
- PIL retired pending re-submission