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4.4       Special warnings and precautions for use

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

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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

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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

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.

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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 severitymagnitude.

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)

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).

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.

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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.

Madopar 50 mg/12.5 mg: Each tablet contains 50mg Levodopa and 12.5mg Benserazide (as benserazide hydrochloride).

 Madopar 100 mg/25 mg: Each tablet contains 100.0 mg Levodopa and 25 mg Benserazide (as benserazide hydrochloride).