Source: Web Search Revision Year: 2013 Publisher: Les Laboratoires Servier
This medicine is contra-indicated in the following situations:
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.
Considering the age of the population treated with piribedil, the risk of falls whether due to hypotension, sudden sleep onset or confusional state should be considered.
Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including TRIVASTAL. Dose reduction/tapered discontinuation should be considered if such symptoms develop.
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.
Reciprocal antagonism between dopaminergic agonist and neuroleptics. Use an anti-emetic devoid of extrapyramidal effects.
Reciprocal antagonism between dopaminergic agonist and neuroleptics.
The dopaminergic agonist can induce or aggravate psychotic disorders. If a neuroleptic treatment is required in patients with Parkinson’s disease treated with dopaminergic agonists, the latter must be decreased progressively until full withdrawal (a sudden withdrawal of dopaminergics exposes to a risk of “malignant neuroleptic syndrome”).
Reciprocal antagonism between dopaminergic agonists and tetrabenazine.
Increase of piribedil sedative effect by the alcohol.
The modification of vigilance could make driving and using machines dangerous.
Increase in central depression.
The modification of vigilance could make driving and using machines dangerous.
This medicine is restricted to elderly subjects, for whom the risk of pregnancy does not exist.
In the absence of relevant data, the use of this drug during pregnancy or breastfeeding is not recommended.
Patients treated with piribedil presenting somnolence and/or sudden sleeping fits, must be told not to drive vehicles or perform an activity in which an alteration of alertness could expose them or other persons to a risk of serious accident or death (for example the use of machinery) until the disappearance of such effects (see section 4.4).
The following undesirable effects have been observed during treatment with piribedil and ranked under the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data).
The following symptoms may occur:
Common: minor gastrointestinal disorders (nausea, vomiting, flatulence), which may disappear particularly if the individual dose is adjusted (gastro-intestinal symptoms can be greatly reduced by stepwise uptitration (50mg increase every 2 weeks).
Common: psychic disorders such as confusion, hallucinations or agitation have been observed, which disappear when treatment is stopped.
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including TRIVASTAL (see section 4.4 “Special warnings and precautions for use”).
Common: dizziness has been observed which disappears when treatment is stopped.
Piribedil is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Uncommon: hypotension, orthostatic hypotension with syncope or malaise or unstable blood pressure. Due to the presence of Cochineal red, risk of allergic 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Not applicable.
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