Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Pharmacia Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 20/12/2010
SPC Dostinex 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 20/12/2010 and displayed until Current
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 4.5 - 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
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC Update to sections 4.3,4.4,4.5,4.6,4.7,4.8&4.9
Updated on 01/06/2009 and displayed until 20/12/2010
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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 - Restriction of maximum dose to 3mg per day.

Section 4.3 - Clarification of contraindication in patients with cardiac valvulopathy on long-term treatment.

 Clarification of contraindication in patients with cardiac valvulopathy on long-term treatment.

Section 4.4 - Inclusion of warning regarding use in pregnancy and clarification of warnings and precautions for use in long-term treatment.

Inclusion of warning regarding use in pregnancy andclarification of warnings and precautions for use in long-term treatment.

Section 4.8 - Frequency information represented in accordance with EU guidance and frequency data included for cardiac valvulopathy and related disorders.

Frequency information represented in accordance with EU guidance and frequency data included for cardiac valvulopathy and related disorders.

Section 10 - Date of revision updated.

Date of revision updated.
Updated on 18/08/2008 and displayed until 01/06/2009
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:   01-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 – Updated with warnings regarding fibrosis/valvulopathy

Section 4.8 – Postmarketing surveillance data updated with fibrosis and valvulopathy

Section 10 – date of revision updated
Updated on 16/11/2007 and displayed until 18/08/2008
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:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.4 – Addition of warnings regarding pathological gambling, increased libido and hypersexuality.

4.8 – Addition of side effects - pathological gambling, increased libido and hypersexuality and addition of post-marketing surveillance data.
Updated on 06/07/2007 and displayed until 16/11/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Pending awaiting re-submission
  • Pending awaiting re-submission
  • Pending awaiting re-submission
  • Pending awaiting re-submission
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7 Marketing Authorisation Holder

Address Change from Milton Keynes to Sandwich
Updated on 28/09/2004 and displayed until 06/07/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 19/05/2003 and displayed until 28/09/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • 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 10 (date of (partial) revision of the text
Updated on 30/10/2002 and displayed until 19/05/2003
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Addition of Legal Category
Updated on 29/10/2002 and displayed until 30/10/2002
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 21/08/2002 and displayed until 29/10/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text

Active Ingredients/Generics

 
  cabergoline