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Boehringer Ingelheim Limited
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 298
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 12/07/2011
SPC Mirapexin 0.088 mg tablets

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 12/07/2011 and displayed until Current
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:   17-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 has been updated to include information relating to cardiac failure and amendments have been made in relation to the frequency information for some side effects

Section 10:
Date of revision of the text has also been updated.
Updated on 21/01/2011 and displayed until 12/07/2011
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   20-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.3:
Section 5.3 of the SPC has been updated to include information concerning delayed sexual development observed in rats. The following statement has been added:

'A delay in sexual development (i.e., preputial separation and vaginal opening) was observed in rats. The relevance for humans is unknown.'

Section 7:
Please also note that a minor change has been made to the MA holder address i.e.
'Binger Straße 173' has been revised to 'Binger Strasse 173' to align with the commission annexes.

Section 10:
Date of revision of the text has also been updated.
Updated on 17/12/2010 and displayed until 21/01/2011
Reasons for adding or 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 10 date of revision of the text
  • Removal of Black Triangle
Date of revision of text on the SPC:   25-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Black Triangle removed.

Section 4.2
Minor correction.

Section 4.5
update to include the results of an in depth evaluation of hOCT2 inhibitors

Section 4.6
revision of information on fertility

Section 4.8
update of information based on PSUR 13 to include new side effects and revise frequency categories

Date of revision amended.
Updated on 14/09/2010 and displayed until 17/12/2010
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Removal of the Black Triangle

Updated on 19/07/2010 and displayed until 14/09/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 & 5.1
Information added regarding use in Paediatric population.

Section 10
Date of revision of text updated.
Updated on 02/07/2010 and displayed until 19/07/2010
Reasons for adding or 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 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


- Update to sections 4.2, 4.4 and 5.1 to incorporate new clinical data relating to the Restless Legs indication.

- Minor editorial changes to sections 4.1, 4.2 and 5.1

- Reformatting of section 4.6 in line with current guidance

 

- Update of revision date to 17 June 2010 – Section 10
Updated on 23/10/2009 and displayed until 02/07/2010
Reasons for adding or 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 5.1 - Pharmacodynamic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 4.2     Posology and method of administration


Dosing in patients with renal impairment

Addition of statement “A maximum daily dose of 1.57 mg pramipexole base (2.25 mg of salt) should not be exceeded”

 

Addition of statement “A maximum daily dose of 1.1 mg pramipexole base (1.5 mg of salt) should not be exceeded”

 
4.5     Interaction with other medicinal products and other forms of interaction

 

Addition of “mexiletine”

 
5.1     Pharmacodynamic properties

 

Addition of “In a clinical trial with healthy volunteers, where {TRADE NAME} prolonged-release tablets were titrated faster (every 3 days) than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood pressure and heart rate was observed. Such effect was not observed in patient studies”


 6.5     Nature and contents of container

 

Addition of “OPA/aluminium/PVC-aluminium blisters.

Each blister strip contains 10 tablets.”

 
10.     Date of revision of the text

Updated to “8 October 2009”

 
Updated on 11/05/2009 and displayed until 23/10/2009
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:   17-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.8

The addition of two uncommon side effects - dyspnoea and pneumonia to section 4.8

 

Section 10

Date of revision revised to 17 April 2009

Updated on 25/02/2009 and displayed until 11/05/2009
Reasons for adding or 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
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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:   26-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4
In this section paragraph headings have been added.

In the paragraph with the heading 'Impulse control disorders and compulsive behaviours' the following change has been made:
'that behavioural changes can occur' amended to 'that other behavioural symptoms of impulse control disorders and compulsions such as binge eating and compulsive shoping can occur'

Section 4.5
In this section paragraph headings have been added.

Section 4.8
In this section paragraph headings have been added.

Additional information regarding abnormal behaviour under the paragraph with the heading 'Expected adverse events'

The following adverse reactions are expected under the use of MIRAPEXIN:

abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesias, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.

Under frequencies (< 1/10,000); the follwoing definition has been added ' not known (cannot be estimated from the available data).'

Table 1 and 2 amended to include the changes mentioned above.

New last paragraph at the end of section 4.8.

Section 5.1
ATC code amended 'N04BC05'

Section 8
/ added after 'EU' in MA number

Section 10
Date of revision amended
Updated on 16/10/2008 and displayed until 25/02/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.8 completely reworded , tables amended

 

Section 5.1 ATC Code amended from NO4B C to NO4BC05

 

Section 6.1 povidone amended to povidone K 25

 

Section 10 date of revision of text amended
Updated on 11/04/2008 and displayed until 16/10/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Update to section 4.5 to add hypersexuality and amendment to section 4.8 (new side effects and frequencies), update to section 9 Date of Renewal and 10 Date of Revision of Text.
Updated on 17/01/2008 and displayed until 11/04/2008
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
New 0.35mg strength tablet added.
Updated on 03/11/2006 and displayed until 17/01/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 Addition of statement on behavioural changes.
 
Section 4.8 Addition of side effects: abnormal behaviour, abnormal dreams, delusion, hyperkinesias, increased eating (binge eating, hyperphagia), paranoia, weight increase.
Updated on 20/09/2006 and displayed until 03/11/2006
Reasons for adding or updating:
  • Addition of Black Triangle
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Black Triangle status has been added to the new indication of Restless Legs Syndrome only.  This does not apply to use in the treatment of Parkinson's Disease
Updated on 27/04/2006 and displayed until 20/09/2006
Reasons for adding or 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
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   06/04/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1/4.2  New indication for Restless Legs Syndrome.
 
Section 4.4 Dose adjustment for Restless Legs Syndrome.
 
Section 4.8 New table incorporating adverse event data from both Parkinson's disease and Restless Legs Syndrome clinical trials.  Also lists most common RLS side effects.
 
Section 5.1 Addition of clinical trial data for Restless Legs Syndrome.
Updated on 06/07/2005 and displayed until 27/04/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 08/03/2005 and displayed until 06/07/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 26/10/2004 and displayed until 08/03/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 16/12/2002 and displayed until 26/10/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Change of Marketing Authorisation Holder.
Updated on 13/12/2002 and displayed until 16/12/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Updated on 11/12/2001 and displayed until 13/12/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/11/2001 and displayed until 11/12/2001
Reasons for adding or 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 4.5 - 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 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
  • Change to separate SPCs covering individual presentations

Active Ingredients/Generics

 
  pramipexole dihydrochloride monohydrate