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Roche Products Limited

Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
Telephone: +44 (0)1707 366 000
Fax: +44 (0)1707 338 297
WWW: http://www.rocheuk.com
Medical Information Direct Line: +44 (0)800 328 1629
Medical Information e-mail: medinfo.uk@roche.com
Customer Care direct line: +44 (0)800 731 5711
Medical Information Fax: +44 (0)1707 384555

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Summary of Product Characteristics last updated on the eMC: 18/12/2012
SPC Madopar CR Capsules 125

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 18/12/2012 and displayed until Current
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:   06-Dec-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Underlined text = new text

Strike through text = deleted text

4.4       Special warnings and precautions for use

[ …]

 

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

 

[ …]


Impulse control disorders


Patients should be regulatory monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa, including Madopar. Review of treatment is recommended if such symptoms develop. 

 

4.8       Undesirable effects

[ …]

 

Neuropsychiatric:

-          Psychiatric disturbances are common in Parkinsonian patients, including those treated with levodopa, including mild elation, anxiety, agitation, insomnia, drowsiness, depression, aggression, delusions, hallucinations, temporal disorientation and “unmasking” of psychoses.

 

-          Levodopa is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.

 

-          Patients treated with dopamine agonists and/or levodopa 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 the dose of treatment discontinuation.

 

-          Involuntary movements (e.g. choreiform or athetotic, oral dyskinesias, “paddling” foot) are common, particularly on long-term administration.  These are usually dose-dependant and may disappear or become tolerable after dose adjustment.

 

Impulse Control Disorders:

-          Pathological gambling, increased libido and hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Madopar. (see section 4.4. ‘Special warnings and precautions for use’)

 

10      Date of revision of the text

February 2010

December 2012

Updated on 19/05/2011 and displayed until 18/12/2012
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   27-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Underlined text has been added:

6.1       List of Excipients

Capsule contents:

Hypromellose (E464)

Hydrogenated vegetable oil

Calcium hydrogen phosphate, anhydrous (E341)

Mannitol (E421)

Talc (E553b)

Povidone (E1201)

Magnesium stearate (E572)

 

Capsule shell:

Gelatin

Indigo carmine (E132)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Updated on 29/04/2009 and displayed until 19/05/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   20-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

The following underlined text has been added to section 4.8:

Laboratory abnormalities:

-        Transient rises in SGOT, SGPT and alkaline phosphatase values have been noted.

-        Increase of gamma-Glutamyltransferase has been reported.

-        Serum uric acid and blood urea nitrogen levels are occasionally increased.

Updated on 17/09/2007 and displayed until 29/04/2009
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.9       Overdose symptoms, emergency procedures, antidotes

Symptoms and signs

Symptoms and signs of overdosage are qualitatively similar to the side-effects of Madopar in therapeutic doses but may be of greater severity.magnitude.

 

Overdose may lead to cardiovascular side effects (e.g. cardiac arrhythmias), psychiatric disturbances (e.g. confusion and insomnia), gastro-intestinal effects (e.g. nausea and vomiting) and abnormal involuntary movements (see section 4.8).

 

If a patient has taken an overdose of Madopar CR, occurrence of symptoms and signs may be delayed due to delayed absorption of the active substances from the stomach.

 

Treatment

Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state.  In particular patients may require symptomatic treatment for cardiovascular effects (e.g. antiarrhythmics) or central nervous system effects (e.g. respiratory stimulants, neuroleptics).

 

In addition, for Madopar CR further absorption should be prevented using an appropriate method.

 

Treatment should include gastric lavage, general supportive measures, intravenous fluids and the maintenance of an adequate airway.

 

Electrocardiographic monitoring should be instituted and the patient carefully observed for the possible development of arrhythmias.  If necessary, anti-arrhythmic therapy should be given and other symptoms treated as they arise.

Updated on 24/08/2007 and displayed until 17/09/2007
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:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 

Underlined text has been added, text with strike through deleted:

 

4.4              Special warnings and precautions for use

 

Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists and/or levodopa for Parkinson’s disease.  Madopar is not a dopamine agonist, however caution is advised as Madopar is a dopaminergic drug.

 

4.8              Undesirable effects

 

-          Patients treated with dopamine agonists and/or levodopa 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 the dose of treatment discontinuation.  Madopar is not a dopamine agonist, however there is the possibility that these adverse effects may occur as Madopar is a dopaminergic drug.

 

Updated on 22/05/2006 and displayed until 24/08/2007
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   31/01/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 1

Any reference to 125mg has been changed to read 100mg/25mg.

 

Section 4.2:

Any reference to 125mg has been changed to read 100mg/25mg.

 

Section 6.4:

Reference to "container" changed to "bottle"

 

Section 9:

Date of renewal changed

 

Section 10:

Date of revision changed

 

Updated on 06/03/2003 and displayed until 22/05/2006
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Updated on 11/09/2002 and displayed until 06/03/2003
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 23/10/2001 and displayed until 11/09/2002
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 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 15/08/2001 and displayed until 23/10/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 15/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics