IRESSA 250 mg film-coated tablets * Pharmacy Only: Prescription
Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
No Recent UpdateLegal 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
Updated on 13 July 2022
File name
62cee6a75814c.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Inserted text, Deleted text
[…]
4. Possible side effects
[…]
Reporting of side effects
[…]
Ireland
HPRA Pharmacovigilance
Website: www.hpra.ie
Malta
ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal
United Kingdom (Northern Ireland)
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
[…]
6. Contents of the pack and other information
[…]
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Ireland
AstraZeneca Pharmaceuticals (Ireland) Ltd DAC
Tel: +353 1609 7100
Malta
Associated Drug Co. Ltd
Tel: +356 2277 8000
United Kingdom (Northern Ireland)
AstraZeneca UK Ltd
Tel: +44 1582 836 836
This leaflet was last revised in 07/2022 01/2021
[…]
Updated on 13 July 2022
File name
62ced4f8190b8.pdf
Reasons for updating
- 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
Inserted text, Deleted text
[…]
4.8 Undesirable effects
[…]
Reporting of suspected adverse reactions
[…]
Ireland
HPRA Pharmacovigilance
Website: www.hpra.ie
Malta
ADR Reporting Website:
www.medicinesauthority.gov.mt/adrportal
United Kingdom (Northern Ireland)
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
[…]
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE02 L01EB01
[…]
10. DATE OF REVISION OF THE TEXT
04th July 2022 14th January 2021
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
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
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
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 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
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
Updated on 24 July 2009
Reasons for updating
- New PIL for new product
- PIL retired pending re-submission