Piribedil

Increase in central depression.

The modification of vigilance could make driving and using machines dangerous.

Caution is advised when administered to patients with hepatic and/or renal insufficiency.

Increase of piribedil sedative effect by the alcohol.

The modification of vigilance could make driving and using machines dangerous.

Reciprocal antagonism between dopaminergic agonists and tetrabenazine.

Piribedil is restricted to elderly subjects, for whom the risk of pregnancy does not exist.

In the absence of relevant data, the use of piribedil during pregnancy is not recommended.

In the absence of relevant data, the use of piribedil during 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.

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:

Gastrointestinal disorders

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).

Psychiatric disorders

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 piribedil.

Nervous system disorders

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.

Vascular disorders

Uncommon: hypotension, orthostatic hypotension with syncope or malaise or unstable blood pressure. Due to the presence of Cochineal red, risk of allergic reactions.