Madopar 250/Madopar HBS/Madopar Dispersible 125 Adverse Reactions

Blood and Lymphatic System Disorders: Hemolytic anemia, transient leukopenia and thrombocytopenia have been reported in rare cases. Therefore, as in any long-term levodopa-containing treatment, blood cell count and liver and kidney function should be monitored periodically.
Metabolic and Nutritional Disorders: Anorexia has been reported.
Psychiatric Disorders: Depression can be part of the clinical picture in patients with Parkinson's disease and may also occur in patients treated with Madopar. Agitation, anxiety, insomnia, hallucinations, delusions and temporal disorientation may occur particularly in elderly patients and in patients with a history of such disorders. Dopamine dysregulation syndrome (DDS) has been reported.
Nervous System Disorders: Isolated cases of ageusia or dysgeusia have been reported. At later stages of the treatment, dyskinesia (e.g. choreiform or athetotic) may occur. These can usually be eliminated or be made tolerable by a reduction of dosage. With prolonged treatment, fluctuations in therapeutic response may also be encountered.
They include freezing episodes, end-of-dose deterioration and the "on-off" effect. These can usually be eliminated or made tolerable by adjusting the dosage and by giving smaller single doses more frequently. An attempt at increasing the dosage again can subsequently be made in order to intensify the therapeutic effect. Madopar is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Cardiac Disorders: Cardiac arrhythmias may occur occasionally.
Vascular Disorders: Orthostatic hypotension may occur occasionally. Orthostatic disorders commonly improve following reduction of the Madopar dosage.
Gastrointestinal Disorders: nausea, vomiting and diarrhea have been reported with Madopar. Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking Madopar with some food or liquid or by increasing the dose slowly.
Skin and Subcutaneous Tissue Disorders: Allergic skin reactions such as pruritus and rash may occur in rare cases.
Investigations: Transient elevation of liver transaminase and alkaline phosphatase may occur. Increase of gamma-glutamyltransferase has been reported.
Rises in blood urea nitrogen have been noted with Madopar.
Urine may be altered in color, usually acquiring a red tinge which turns dark on standing. Other body fluids or tissues may also be discoloured or stained including saliva, the tongue, teeth or oral mucosa.
Laboratory Abnormalities: See Post Marketing in the previous text.