Afinitor Tablets

Product Information *

  • Company:

    Novartis Ireland Limited
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 09 July 2021

File name

Afinitor_REG PIL_2.5mg_10mg_5mg_Tab_17-Jun-21_Clean_1625844554.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer

Updated on 09 July 2021

File name

Afinitor_REG SPC_PF21-0155_17.06.2021_clean_1625840298.pdf

Reasons for updating

  • 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 29 June 2021

File name

Afinitor_REG SPC_PF21-0155_17.06.2021_clean_1624965536.pdf

Reasons for updating

  • 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 4.8 - Undesirable effects

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

Updated on 02 November 2020

File name

Afinitor_10mg_2.5mg_5mg REGPIL_Tab__PF20-0212_IPHA_1604324642.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 23 June 2020

File name

Afinitor Tabs REGSPC PF 20-0121_June 2020 Clean_1592923025.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Updated on 01 May 2020

File name

Afinitor_10mg_2.5mg_5mg REGPIL_Tab__Clean Feb 2020_1588329060.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 28 June 2019

File name

REG PIL_Afinitor_10mg_2.5mg_5mg_Tab_PF19-0089_Clean_IPHA_1561725517.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to name of medicinal product

Updated on 18 April 2019

File name

Afinitor_REG SPC_PF 19-0089_IPHA_1555600643.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 6.1 - List of excipients
  • 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 03 April 2019

File name

Afinitor REG SPC_PF 18-0273_corrected_clean_1554285457.pdf

Reasons for updating

  • 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 28 January 2019

File name

Afinitor REG SPC_PF 18-0273_clean_IPHA_1548669816.pdf

Reasons for updating

  • Other

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

Updated on 12 November 2018

File name

Afinitor REG SPC_PF 18-0273_clean_1542046396.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 15 October 2018

File name

Afinitor Tablets REG PIL_2212802_R91_IPHA_1539596841.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 29 May 2018

File name

Afinitor_REG_SPC_PF_18-0120_clean.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 16 October 2017

File name

PIL_15742_903.pdf

Reasons for updating

  • New PIL for new product

Updated on 16 October 2017

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 August 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the 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

Sections 4.4 and 5.1 have been revised to include new safety information on stomatitis and its management based on final results from a study of the use of steroid-based mouthwash to prevent stomatitis in post-menopausal women with advanced or metastatic hormone receptor positive breast cancer being treated with everolimus plus exemestane.
Section 4.6 has been updated with new information on breast-feeding based on pre-clinical data.
Section 9 has been revised to correct the last date of renewal. 

Updated on 28 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 25 July 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 03 June 2016

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • 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

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

Free text change information supplied by the pharmaceutical company

Update to include new indication which reads as follows: Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1).
Other sections updated to reflect corresponding data.

 

Updated on 17 September 2015

Reasons for updating

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

Updated on 01 May 2015

Reasons for updating

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

Updated on 09 April 2015

Reasons for updating

  • Change to section 5 - Pharmacological properties
  • 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 5.1 has been updated with the following statement:

Following disease progression or after study unblinding, 172 of the 203 patients (84.7%) initially randomised to placebo crossed over to open-label Afinitor. The median duration of open-label treatment was 47.7 weeks among all patients; 67.1 weeks in the 53 patients randomised to everolimus who switched to open-label everolimus and 44.1 weeks in the 172 patients randomised to placebo who switched to open-label everolimus.
Also, "Median overall survival (months) (95% CI)" data included in table.

Section 7 updated to reflect new MAH address.

Updated on 23 March 2015

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

in Section 4.4, pneumocystis jiirovecci carinii pneumonia (PJP/PCP) is added as a warning and Section 4.8 has been updated as a result of pooled safety data.

Updated on 27 January 2015

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 03 July 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 4.7 - 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 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation

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; In Table 1 "Afinitor" has been changed to "treatment". Change Elderly people to Elderly patients.
Section 4.4: Change Afinitor to Everolimus. The following paragraph has been added after Hypersensitivity.
Concomitant use of angiotensin-converting enzyme (ACE) inhibitors..........................................
Section 4.5 has been updated with a paragraph above Vaccinations....Concomitant use of angiotensin-converting enzyme (ACE) inhibitors...............................................................................
Section 4.7 has been updated re. driving and using machinery
Section 4.8 has been updated with minor changes in the paragraph titles
Section 5.2 Afinitor changed to everolimus
Section 6.5 Pack size of 60 has been deleted for 5mg and 10mg
Section 9 - Date of latest renewal has been included

Updated on 18 March 2014

Reasons for updating

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

Update to Section 4.4 re. Dyslipidemia and to Section 4.8 - update of Undesirable effects and frequency of some undesirable effects.

Updated on 19 February 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 08 January 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Update to Section 4.5 to include further information regarding interactions.
Update to Section 4.8 to include more information on sfatey reporting.

Updated on 27 November 2013

Reasons for updating

  • Addition of joint PIL covering all presentations

Updated on 10 July 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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 SPC for Afinitor has been updated. The updates relate to Sections 4.2, 4.5,4.6,4.8 and 5.1 of the SmPC to add clarification on dose recommendations to manage most commonly occurring adverse events and to add information on amenorrhea observed in female patients in Section 4.6 and 4.8.

Updated on 17 May 2013

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 January 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

New tablet strength licensed for Afinitor - 2.5mg Tablet