Login

Aromasin 25 mg coated tablets

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Exemestane

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

Updated on 13 June 2022

File name

Reg SPC AM 10_0 IE clean.pdf

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)

Updated on 13 June 2022

File name

Reg PIL AM 11_0 IE Clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 12 February 2021

File name

DEC202109781_Reg SPC AM 9_0 IE Clean.pdf

Reasons for updating

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

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

Updated on 02 October 2020

File name

Reg PIL AM 10_0 IE Clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 31 January 2019

File name

Reg PIL AM 9_0 IE clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • 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 31 January 2019

File name

Reg SPC AM 8_0 IE clean.pdf

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 4.5 - 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 - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

The following changes to the labelling have been approved.  Please refer to attached copy/copies of labelling documentation for full details.

The SPC has been updated as follows:

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Update in line with QRD wording

 

4.3       Contraindications

Section updated to revise paragraph for readability purposes

 

4.4       Special warnings and precautions for use

Methyl-p-hydroxybenzoate updated to methyl parahydroxybenzoate

 

4.5       Interaction with other medicinal products and other forms of interaction

Wording within section updated from drugs to medicinal products

 

4.6       Fertility, pregnancy and lactation

Administrative update

 

4.7       Effects on ability to drive and use machines

New statement added:

Exemestane has moderate influence on the ability to drive and use machines.

 

4.8       Undesirable effects

Reporting details updated

 

6.1       List of excipients

Methyl-p-hydroxybenzoate updated to methyl parahydroxybenzoate

 

6.6       Special precautions for disposal and other handling

Section revised to;

No special requirements for disposal.

Updated on 26 June 2018

File name

Reg PIL AM 8_0 IE clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 02 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 02 January 2018

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • 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

The SPC has been updated as follows:
5.1. Pharmacodynamic properties – Section updated to include the 10-year final follow-up results from the Intergroup Exemestane Study (IES) 96 OEXE-031 (A5991012).

5.3. Preclinical safety data – The MHRA requested to consider omitting the proposed addition to this section therefore no update has been made. (i.e. no change to the currently approved version for Section 5.3).

Updated on 16 July 2015

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 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 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows

4.1.   Therapeutic indications – Section updated in line with QRD

4.2.   Posology and method of administration – Section updated in line with QRD

4.3.   Contraindications - Section updated in line with QRD

4.4.   Special warnings and precautions for use -  Section updated with date on osteoporosis and Vitamin D supplementation

4.5.   Interaction with other medicinal products and other forms of interaction - Section updated in line with QRD

4.6.   Fertility, pregnancy and lactation - Section updated in line with QRD

4.8.   Undesirable effects -  section updated in line with QRD and to include data  in line CDS

5.1.         Pharmacodynamic properties - Section updated in line with QRD

5.2    Pharmacokinetic properties - Section updated in line with QRD

5.3.   Preclinical safety data – Section updated to improve electronic presentation

6.1.   List of excipients - Section updated to improve electronic presentation

Updated on 15 July 2015

File name

PIL_9396_377.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 July 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability

Updated on 31 January 2013

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)

Free text change information supplied by the pharmaceutical company

Section 5.1

The SPC was updated to reflect the updated efficacy and safety data of exemestane for the adjuvant treatment of women with EBC obtained from the primary and secondary end point analysis of the 96-OEXE-031 Main Study at 87-Months follow-up and the final analyses of the 96-OEXE-031 Bone Substudy.

 

The safety results from the 87-months follow-up study confirm the safety profile of the product is unchanged. Thus no safety updates are herewith included in the Summary of Product Characteristics.

Section 4.8

The addition of “Intergroup Exemestane Study (IES)” is included in the introductory text of section 4.8 to detail the origin of adverse event data.

Updated on 22 June 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

Change to Marketing Authorisation details and PA number.

Updated on 19 June 2012

Reasons for updating

  • Change of licence holder
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 19 October 2011

Reasons for updating

  • 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

SmPC – Section 7 - MA holder name change and Section 10 – revision date.

Updated on 18 October 2011

Reasons for updating

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

Updated on 01 August 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 31 July 2009

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 updated with adverse drug reactions of hepatitis.

Updated on 29 July 2009

Reasons for updating

  • Change to side-effects

Updated on 12 November 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section

Updated on 11 November 2008

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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

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

Free text change information supplied by the pharmaceutical company

Section 2: Clarity on what the tablet contains.

Section 4.6: Section updated with information on women with child-bearing potential

Section 4.8: Updated with further data.

Section 6.1: Section edited.

Section 6.4: Updated statement on storage.

Section 6.6: Heading updated as per current QRD template.

Section 9: date updated with renewal approval

Updated on 30 April 2008

Reasons for updating

  • Improved electronic presentation
  • Change to drug interactions

Updated on 03 October 2007

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

4.4 – Update on osteoporosis and reformatting

4.8 – Side effects: Osteoporosis and fracture added. Section also updated to reflect safety results

5.1 – efficacy results updated  

Updated on 07 August 2006

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 31 July 2006

Reasons for updating

  • Change of manufacturer

Updated on 06 October 2005

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

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

Updated on 06 October 2005

Reasons for updating

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

Updated on 03 August 2005

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Updated on 21 March 2005

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Updated on 28 February 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 February 2004

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

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