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Pramipexole Accord 0.35mg tablets

Last Updated on eMC 24-Jun-2014 View document  | Accord Healthcare Limited 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.

Updated on 24-Jun-2014 and displayed until Current

Reasons for adding or 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

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections 4.4 and 4.8 to include mania and delirium as adverse drug reactions and to add a new warning to inform healthcare professionals about the possibility of these events to occur under pramipexole treatment as well as the need for monitoring patients and dose adjustment.

Updated on 06-Mar-2014 and displayed until 24-Jun-2014

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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: 17-Jan-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updated section 4.4 with the implementation of class labelling for the risk of impulse control disorders. Section 4.8 was updated accordingly. Section 4.8 was also updated include inappropriate antidiuretic hormone secretion as an adverse drug reaction based on post-marketing data and safety information related to cardiac failure. Updated were also made to bring the SPC in line with the most current QRD template. In section 7 the address of the MAH was updated.  

Updated on 11-Dec-2012 and displayed until 06-Mar-2014

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 06-Nov-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 6.3, the shelf-life has been changed from 18 months to 24 months.

Updated on 22-Feb-2012 and displayed until 11-Dec-2012

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Accord Healthcare Limited

Company image
Address

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK

Fax

+44 (0)208 863 1426

Medical Information e-mail
Medical Information Fax

+44 (0)208 863 1426

Telephone

+44 (0)208 8631 427

Medical Information Direct Line

+44 (0)208 901 3370

Customer Care direct line

+44 (0)208 863 1427

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?

Active ingredients

pramipexole dihydrochloride monohydrate

Legal categories

POM - Prescription Only Medicine

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