Last Updated on eMC 25-09-2017 View medicine  | Astellas Pharma Ltd Contact details

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.

Reasons for adding or updating:

  • 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 - Fertility, 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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

Date of revision of text on the SPC:18-09-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



This update follows the routine 5-yearly renewal of the Betmiga licence in the EU, resulting in the removal of the black triangle and additional monitoring wording from both the SmPC and the PIL. In addition, administrative and editorial updates have been made throughout the SmPC.

Section 9 and 10 have been updated with the European Commission approval date of 18 September 2017.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Date of revision of text on the SPC:31-03-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key changes associated with this update are as follows:

 

Section 4.8 Undesirable effects

Addition of the following within the AE table (all observed post-marketing):

 

Hypertensive crisis (frequency very rare)

Constipation (frequency common)

Diarrhoea (frequency common)

Headache (frequency common)

Dizziness (frequency common)

 

Section 10 Date of Revision has been updated to reflect the European Commission decision date of 31 March 2016.

 

Editorial changes have been made to Section 2, 3, 6.1 and 8 to reflect the fact that the European SmPC has been combined for both strengths (the UK SmPC has always been combined).

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • 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

Date of revision of text on the SPC:14-09-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Severe uncontrolled hypertension is now listed as a contraindication is Section 4.3, along with an associated warning in Section 4.4. Additionally, insomnia and urinary retention are added to Section 4.8. 
 

The complete list of changes are:


Section 4.3 Contraindications

“Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg” added as a contraindication.

 

Section 4.4 Special warnings and precautions for use

New wording under the ‘hypertension’ section: “Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with Betmiga, especially in hypertensive patients.”

 

Section 4.8 Undesirable effects

Addition of Insomnia (observed during post-marketing) under Psychiatric disorders with an associated frequency of Not known.

Addition of Urinary retention (observed during post-marketing) under Renal and urinary disorders with an associated frequency of Rare.


Section 5.1 Pharmacodynamic properties

Update to Table 3 (Co-primary efficacy endpoints for patients with prior OAB antimuscarinic therapy) - Patients with prior OAB antimuscarinic therapy who discontinued due to insufficient effect

Amendment of the n value (from 155 to 159) for the mean number of micturitions per 24 hours (FAS) measurement for patients on placebo in the -046 study.

 

Section 10 Date of Revision has been updated to reflect the European Commission decision date of 14th Setpember 2015.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:16-03-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.8 (Undesirable effects) has been updated to include Nausea (observed during post-marketing experience) as ‘Common’ under ‘Gastrointestinal disorders’.

 

Section 10 Date of Revision has also been updated.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:19-11-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.8 (Undesirable effects) has been updated to include Angioedema (observed during post-marketing experience) as ‘rare’ under ‘Skin and subcutaneous tissue disorders’.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Date of revision of text on the SPC:23-04-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The key change is the addition of a paragraph entitled ‘Patients with bladder outlet obstruction and patients taking antimuscarinics medications for OAB’ under Section 4.4 (Special warnings and precautions for use). This new paragraph advises that Betmiga be administered with caution in these patients.  

 

In addition, the name ‘mirabegron’ has been substituted for ‘Betmiga’ at several points throughout the document.

 

Section 10 Date of Revision has also been updated.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
  • 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:22-01-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The mandatory black triangle now sits above the main text of the SPC, adjacent to explanatory wording.

Section 4.8 (Undesirable effects):

 

– addition of mandatory text regarding the reporting of adverse reactions to the MHRA via the Yellow Card Scheme.

 

Section 6.5 (Nature and contents of container):

– addition of 50 and 100 pack size (each strength)

 

Section 8 (Marketing Authorisation Number(s)):

– addition of new licence numbers for the 50 and 100 pack size (each strength)

 

Section 10 Date of Revision has also been updated.

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES