Trivastal Retard 50 Special Precautions

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 Piribedil (Trivastal Retard 50). 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.
Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur.
Peripheral edema: Peripheral edema 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.
Piribedil (Trivastal Retard 50) contains sucrose: Due to the presence of sucrose, this medicine is contraindicated in case of fructose intolerance, glucose and galactose malabsorption syndrome or sucrase-isomaltase deficiency.
Effects on the ability to drive and operate machinery: Piribedil (Trivastal Retard 50) can induce drowsiness and sudden sleeping fits. In such cases, patient must not drive nor perform any activity for which an impairment in vigilance could expose the patient or others to a risk of serious accident or death until the disappearance of such effects.