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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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Summary of Product Characteristics last updated on the eMC: 05/01/2012
SPC Mirena

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 05/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The changes are to update the inserter of the intrauterine system for Mirena to the Evolution inserter, which has been re-designed to have fewer preparatory steps before insertion. This has meant changes to the insertion instructions and therefore changes to the Mirena SmPC.

The Sections of the SmPC affected are:
4.2 Posology and method of administration
'Instruction for use and handling'

Updated on 22/09/2011 and displayed until 05/01/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The key changes to the SmPC are:
  • to change the name of the product to 'Mirena 20 micrograms/24 hours intrauterine delivery system'.
Updated on 02/08/2010 and displayed until 22/09/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - 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
Date of revision of text on the SPC:   19-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Key Changes to Mirena SmPC

 

2. Qualitative and Quantitative Composition 

 

Ø      The initial release rate of levonorgestrel has been moved from section 4.2 ‘Posology and method of administration’ to this section and the release rates after 4 and 5 years have been added.

 

4.2 Posology and method of administration

 

This section has been significantly amended.  It has been reordered into specific sections and each section has been expanded with additional information.

 

Ø      The ‘starting treatment’ section has a specific section on the second Mirena indication ‘Protection from endometrial hyperplasia during oestrogen replacement ‘therapy. 

 

Ø      In the instructions for use and handling and ‘How to insert Mirena’ we have been required to add the instructions and diagrams from the Technical Information Leaflet (TIL).

 

Ø      In the ‘How to remove Mirena’ section it now contains the removal information from the TIL.

 

Ø      The previous text on Medical examination has been moved to section 4.4 ‘Secial warnings and precautions for use’ under a specific section ‘Medical Examination’ and modified, including that addition of specific text on HRT use.

 

4.3 Contraindications

 

Ø      ‘Past attack of bacterial endocarditis or of severe pelvic infection in a woman with an anatomical lesion of the heart or after any prosthetic valve replacement’ has been removed as a contraindication.

 

Ø      ‘active or previous severe arterial disease, such as stroke or myocardial infarction’ has been changed to be a contraindication only when Mirena is used in conjunction with an oestrogen for HRT use. However, it has been moved to section 4.4 ‘Special warnings and precautions for use’ as a precaution for contraceptive use.

 

Ø      ‘confirmed or suspected hormone dependent tumours including breast cancer’ has been added as a contraindication.

  

4.4 Special warnings and precautions for use

 

This section has been significantly amended.  It has been reordered into specific sections and each section has been expanded with additional information.

 

Ø      The previous text on Medical examination in section 4.2 has been moved to this section under a specific section ‘Medical Examination’ and modified including specific text on HRT use.

 

Ø      ‘Conditions under which Mirena can be used with caution’

 

‘Confirmed or suspected hormone dependent neoplasia including breast cancer’ has been removed as a warning and is now a contraindication.

 

Previous text on ‘Migraine’ has been shortened to ‘Migraine with aura’.

 

‘active or previous severe arterial disease, such as stroke or myocardial infarction’ has been moved from being a contraindication to be a precaution when used for contraceptive use.

 

Ø      ‘Perforation’

Information on the risk of perforation in post-partum insertions and lactating women has been included.

 

Ø      ‘Pelvic infection’

Advice on what to do for women using Mirena with symptoms and signs suggestive of pelvic infection has been added.

 

Ø      Bleeding irregularities

The previous text has been significantly expanded with specific text for risk in post-menopausal women and risk in post-menopausal women.

 

Ø      Ectopic pregnancy  

The information on the risk of ectopic pregnancy has been expanded.

 

Ø      Breast cancer

A statement on breast cancer has been added with one statement for risk in pre-menopausal women and a separate one for risk in post-menopausal women.

 

 

4.6 ‘Pregnancy and lactation

 

Ø      The statement that ‘ectopic pregnancy should be excluded’ has been moved to be nearer the start of the first paragraph.

 

 

 

4.8 ‘Undesirable Effects

 

Ø      ‘uterine/vaginal bleeding including spotting, oligomenorrhoea, amenorrhoea (see section 5.1) and benign ovarian cysts’ – has been added to Very common undesirable effects.

 

Ø      The MedRA table has been significantly changed to now match the CCDS.

 

Ø      A statement about ectopic pregnancy and breast cancer has been added after the MedRA table.

 

5.1 Pharmacodynamic properties

 

Ø      The text on bleeding patterns, which was previously in section 4.8, has been moved to this section.

 

5.2 Pharmacokinetic properties

 

Ø      The text on plasma levonorgestrel concentrations in post-menopausal users of Mirena has been amended to provide information on levels at 56 weeks, 24 months and 48 months.
Updated on 14/04/2009 and displayed until 02/08/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
They key changes to the SmPC are:
  • Section 4.6 'Pregnancy' has been updated with additional information on the fact that removal of Mirena or probing of the uterus may result in spontaneous abortion.
  • Section 10 ‘Date of Revision of the Text’ has been updated to 24 February 2009. 

 
Updated on 06/02/2009 and displayed until 14/04/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key change to the SmPC is:
Section 4.2 (Posology and method of administration) of the SmPC was revised to include an instruction for the health care professional to check that the Mirena was still intact after removal. 

Updated on 27/06/2008 and displayed until 06/02/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May 2008

Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0547
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 07/09/2004 and displayed until 27/06/2008
Reasons for adding or 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 - Interactions with other Medicaments and other forms of Interaction
  • 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 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/06/2002 and displayed until 07/09/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
Updated on 19/07/2001 and displayed until 27/06/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 10/05/2001 and displayed until 19/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 07/02/2001 and displayed until 10/05/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 11/01/2001 and displayed until 07/02/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 13/09/2000 and displayed until 11/01/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 13/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  levonorgestrel