The following undesirable effects have been identified from post marketing experience with Madopar. (frequency not known, cannot be estimated from the available data) based on spontaneous case reports and literature.
Frequency categories are as follows:
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 (cannot be estimated from the available data) Blood and Lymphatic System Disorder Haemolytic anaemia Leukopenia frequency not known Thrombocytopenia Metabolic and nutritional disorders frequency not known Decreased appetite Psychiatric Disorders Dopamine dysregulation syndrome Confusional state Depression Agitation * Anxiety* Insomnia* Hallucination* Delusion* Disorientation* Pathological gambling Increased libido Hypersexuality Compulsive shopping Binge eating frequency not known Eating disorder symptom Nervous System Disorders Ageusia Dysgeusia Dyskinesia (choreiform and athetotic) Fluctuations in therapeutic response Freezing phenomenon frequency not known End-of-dose deterioration On and off phenomenon Restless legs syndrome Somnolence Sudden onset of sleep Cardiac disorders frequency not known Arrhythmia Vascular Disorders frequency not known Orthostatic hypotension Gastrointestinal disorders Nausea Vomiting Diarrhoea Saliva discolouration Tongue discolouration Tooth discolouration frequency not known Oral mucosa discolouration Liver and Biliary disorders Transaminases increased Alkaline phosphatase increased frequency not known Gamma-glutamyltransferase increased Skin and subcutaneous tissue disorders Pruritusfrequency not known Rash Renal and urinary disorders Blood urea increasedfrequency not known Chromaturia *These events may occur particularly in elderly patients and in patients with a history of such disorders.
Impulse Control Disorders:
Impulse control disorders such as 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.
4).
Nervous System Disorder:
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.
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.
Levodopa-benserazide is associated with somnolence and has been associated very rarely with excessive daytime sleepiness and sudden sleep onset episodes.
Restless Legs Syndrome:
The development of augmentation (time shift of symptoms from the evening/night into the early afternoon and evening before taking the next nightly dose, is the most common adverse effect of dopaminergic long-term treatment. 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.
- Gastro-intestinal bleeding has been reported with levodopa therapy. - Isolated cases of loss or alterations of taste.
Vascular Disorders:
Orthostatic disorders commonly improve following reduction of the Madopar dosage.
Others:
Flushing and sweating have been reported with levodopa.
Investigations:
Urine may be altered in colour; usually acquiring a red-tinge which turns dark on standing. These changes are due to metabolites and are no cause for concern. Other body fluids or tissues may also be discoloured or stained including saliva, the tongue, teeth or oral mucosa.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.