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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: 18/10/2010
SPC Cabaser 1 mg & 2 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 18/10/2010 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-Aug-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 27/01/2009 and displayed until 18/10/2010
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 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3: Clarification of contraindication in patients with cardiac valvulopathy for long-term treatment with Cabaser

Section 4.4: Clarification of warnings and precautions for use in long-term treatment with Cabaser

Section 10: Date of revision updated
Updated on 16/03/2007 and displayed until 27/01/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • 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:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

4.1 – Therapeutic Indications

         Limitations to the indication i.e. second line treatment (in line with the pergolide

         label). (CA_013)

 

4.3 – Contra-indications

         Addition of contra-indications (in line with the pergolide label). Contra-indicated in

         patients with a history of fibrotic disorders or evidence of cardic valvulopathy of any

         valve. (CA_013)

4.4 – Special Warnings and Precautions for Use

         Additional warnings regarding the adverse events fibrosis and cardiac valvulopathy

         in patients after prolonged use of Cabaser. Addition of monitoring requirements before

         initiating treatment and during treatment. (CA_013)

         Additional warning against pathological gambling, hypersexuality and increased libido

         adversed events. (CA_011)

 

 4.8 – Undesirable Effects

          Additional information regarding fibrosis and valvulopathy in line with the pergolide

          label. (CA_013)

          Additional information regarding pathological gambling, hypersexuality and increased

          libido adverse events in patients treated with cabergoline. (CA_011)
Updated on 20/09/2006 and displayed until 16/03/2007
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Addition of a joint SPC for all presentations of Cabaser.
Updated on 20/06/2001 and displayed until 20/09/2006
Reasons for adding or updating:
  • No reasons supplied
Updated on 23/08/2000 and displayed until 20/06/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 23/08/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  cabergoline