Post marketing Experience: The following adverse reactions have been identified from post marketing experience with Madopar (table) based on spontaneous case reports and literature cases.
The corresponding frequency category estimation for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (these reactions are repeated voluntarily from a population of uncertain size, therefore it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure). (See table.)
Click on icon to see table/diagram/image
Blood and Lymphatic System Disorders: Haemolytic anaemia, transient leukopenia and thrombocytopenia have been reported. In any long-term levodopa-containing treatment, blood cell count and liver and kidney function should be monitored periodically.
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.
Nervous System Disorder: At later stages of the treatment, dyskinesia (e.g. choreiform or athetoic) 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 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 sleepiness and sudden sleep onset episodes.
Vascular Disorders: Orthostatic disorders commonly improve following reduction of the Madopar dosage.
Gastrointestinal Disorders: Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking Madopar with a low protein snack or liquid or by increasing the dose slowly.
Investigations: Urine may be altered in colour, 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.