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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com
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Summary of Product Characteristics last updated on the eMC: 09/03/2010
SPC Requip 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 09/03/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   17-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - "Children and Adolescents: The safety and efficacy of ropinirole have not been established in patients under 18 years of age; therefore ropinirole is not recommended for use in patients within this age group."
Updated on 13/10/2009 and displayed until 09/03/2010
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - Added the following text "For a full list of excipients, see section 6.1."

Section 4.4 - Added the following text "Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine."

Section 4.5 - Added the following text "Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during treatment with ropinirole, adjustment of dose may be required."

Section 4.9 - Added the following text "The symptoms of ropinirole overdose are generally related to its dopaminergic activity. These symptoms may be alleviated by appropriate treatment with dopamine antagonists such as neuroleptics or metoclopramide."

and deleted the following text "

 

There have been no incidences of intentional overdose with ropinirole in clinical trials. It is anticipated that the symptoms of ropinirole overdose will be related to its dopaminergic activity."

 

Section 10 - updated with approval date of this variation namely 17-September-2009
Updated on 23/09/2009 and displayed until 13/10/2009
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 -Added the following text "For a full list of excipients, see section 6.1."

Section 4.4 - Added the following text "Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine."

Section 4.5 - Added the following text "Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during treatment with ropinirole, adjustment of dose may be required."

Section 4.9 -Added the following text "The symptoms of ropinirole overdose are generally related to its dopaminergic activity. These symptoms may be alleviated by appropriate treatment with dopamine antagonists such as neuroleptics or metoclopramide."

and deleted the following text "

 

There have been no incidences of intentional overdose with ropinirole in clinical trials. It is anticipated that the symptoms of ropinirole overdose will be related to its dopaminergic activity."

 

 

Section 10 - updated with approval date of this variation namely 17-September-2009
Updated on 10/11/2008 and displayed until 23/09/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   30-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Addition of a statement regarding dyskinesia in patients with advanced PD (related statement added to 4.8)

Section 4.8 - Addition of a statement regarding dyskinesia in patients with advanced PD (related statement added to 4.2)
Updated on 14/08/2008 and displayed until 10/11/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Addition of hypersensitivity reactions
Updated on 28/03/2008 and displayed until 14/08/2008
Reasons for adding or updating:
  • 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:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 - Additional blister material 'PVC/Aclar/PVC'
Section 10 - Update to reflect MHRA date of acknowledgement
Updated on 16/05/2007 and displayed until 28/03/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 15/05/2007 and displayed until 16/05/2007
Reasons for adding or updating:
  • 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
Section 4.8: Corrected deffinition of rare to (>1/10,000 <1/1,1000)
Updated on 29/03/2007 and displayed until 15/05/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
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

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 04/09/2002 and displayed until 29/03/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 30/08/2002 and displayed until 04/09/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 26/07/2002 and displayed until 30/08/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 09/07/2002 and displayed until 26/07/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 24/06/2002 and displayed until 09/07/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 30/05/2002 and displayed until 24/06/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 15/08/2001 and displayed until 30/05/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 10/08/2001 and displayed until 15/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 20/10/2000 and displayed until 10/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 20/10/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ropinirole hydrochloride


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