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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 479 292
Medical Information e-mail: medicalinformationuk@merck.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: 13/11/2009
SPC Sinemet 12.5mg/50mg, 10mg/100mg, 25mg/100mg and 25mg/250mg 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 13/11/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of Excipients
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   03-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Product names have been amended in sections 1, 2, 3, 4.2, 6.1, 8, and 9 of the SmPC (to include pharmaceutical strength in full), as follows:

From 'Sinemet 62.5 Tablets' to 'Sinemet 12.5 mg/50 mg Tablets'

From 'Sinemet 110 Tablets' to 'Sinemet 10 mg/100 mg Tablets'

From 'Sinemet Plus Tablets' to 'Sinemet Plus 25 mg/100 mg Tablets'

From 'Sinemet 275 Tablets' to 'Sinemet 25 mg/250 mg Tablets'
Updated on 31/07/2009 and displayed until 13/11/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Product Acquisition
Date of revision of text on the SPC:   30-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The marketing of the Sinemet range is transferring to Merck Sharp & Dohme Limited from BMS as of 1 August 2009.  The Licence holder remains the same as MSD Ltd.  BMS have been removed from section 7 of the SPC as a licensed distributor.
Updated on 24/10/2008 and displayed until 31/07/2009
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   20-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.4: The wording of the storage statement has been harmonised across the product range to:

Do not store above 25°C. Store in the original package in order to protect from light.

 
Updated on 06/05/2008 and displayed until 24/10/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   21-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 To update section 4.4 of the SPC to include information relating to Melanoma; consequentially the PIL has been updated
Updated on 13/04/2007 and displayed until 06/05/2008
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:   04/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
  4.4              Special warnings and precautions for use

Addition of: 

 Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson's disease

 

4.8              Undesirable effects
 
                Addition of:

Patients treated with dopamine agonists for treatment of Parkinson's disease, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of dose or treatment discontinuation.

7.       MARKETING AUTHORISATION HOLDER

 Distributed by

 Changed to:

Bristol-Myers Squibb Pharmaceuticals Limited,

Sanderson Road, Uxbridge UB8 1DH, UK

10.     DATE OF REVISION OF THE TEXT

Changed to:

        April 2007

 
Updated on 19/01/2005 and displayed until 13/04/2007
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
Updated on 23/10/2003 and displayed until 19/01/2005
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
Updated on 07/02/2003 and displayed until 23/10/2003
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
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/07/2002 and displayed until 07/02/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  levodopa
  carbidopa