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Dyskinesia: In advanced stage Parkinson's disease, in conjunction with levodopa, dyskinesia may occur at the start of treatment with piribedil. In this case, the dose of piribedil should be reduced.
Orthostatic hypotension: Dopamine agonists are known to alter systemic blood pressure regulation resulting in postural orthostatic hypotension.
Monitoring of blood pressure is recommended, particularly at the start of treatment, given the risk of orthostatic hypotension associated with dopamine treatment.
Abnormal behaviour: Abnormal behaviour has been reported and may be associated with manifestations of confusion, agitation, aggression. Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur.
Sleep disorders: Piribedil has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with piribedil. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of dosage or termination of therapy may be considered.
Given the age of the population treated, the risk of falls whether related to hypotension, sudden sleep onset or delirium, must be taken into account.
Impulse control disorders: The onset of impulse control disorders must be regularly monitored in these patients. The patients and those close to them must be informed of the behavioural symptoms of impulse control disorders such as: pathological gambling (compulsive gambling), hypersexuality, increased libido, compulsive spending or shopping, excessive consumption of food and compulsive food disorders, which may appear in patients treated with dopaminergic agonists including TRIVASTAL. A decrease of the doses or progressive discontinuation of the treatment must be envisaged if such symptoms appear.
Psychotic disorders: Dopamine agonists may cause or worsen psychotic disorders such as delusion, delirium, hallucinations (see Interactions).
Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur.
Peripheral oedema: Peripheral oedema has been observed during the use of dopamine agonists. This should be taken into account when prescribing piribedil.
Neuroleptic malignant syndrome: Characteristic symptoms of neuroleptic malignant syndrome have been reported following sudden discontinuation of dopamine treatment (see Dosage & Administration).
Due to the presence of sucrose, this medicine is contra-indicated in case of fructose intolerance, glucose and galactose malabsorption syndrome or sucrase-isomaltase deficiency.
Effect on ability to drive and use machines: Patients being treated with piribedil and presenting with somnolence and/or an episode of sudden sleep episodes, must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved.
