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

Meda Pharmaceuticals

Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU
Telephone: 0845 460 0000
Fax: 0845 460 0002
Medical Information Direct Line: +44 (0)1748 828 810
Medical Information e-mail: meda@professionalinformation.co.uk
Medical Information Fax: +44 (0)1748 828 801
Out of Hours contact: +44 (0)1748 828 810

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: 24/10/2011
SPC Parlodel 5mg Capsules

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 24/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   17-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To update section 5.3 (Preclinical safety data) of the SPC, to include pre-clinical

data that reveals no special hazards for humans, to bring it in line with the most

recent Basic Prescribing Information.

Updated on 18/03/2011 and displayed until 24/10/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   07-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to section 4.1. of SPC
Updated on 27/01/2011 and displayed until 18/03/2011
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 7 - Marketing Authorisation Holder
  • 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:   21-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to sections 4.2, 4.3, 4.4, 4.8, 7, 8 and 10 following approval of change of ownership
Updated on 15/04/2010 and displayed until 27/01/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • 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:   07-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to section 3., 6.1., 6.3, 6.4., 6.5., and 10.
Updated on 15/01/2008 and displayed until 15/04/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • 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:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
  section 7: MA holder changed to 

 Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

UK

section 8: Product Licence changed to   PL 19166/0054
section 10: Changed to November 2007
 
Updated on 26/09/2007 and displayed until 15/01/2008
Reasons for adding or updating:
  • Change to section 4. Clinical Particulars
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

Addition of CHMP requirements for changes to Sections 4.4 and 4.8 of the SmPC

 

 The following has been added to section 4.4:

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

 

The following has been added to section 4.8:

Class effects: Patients treated with dopamine agonists for treatment with Parkinson’s disease, including PARLODEL, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Updated on 26/01/2000 and displayed until 26/09/2007
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  bromocriptine mesilate