Trivastal Retard 50 Adverse Reactions

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 signs may appear: 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 (visual, auditory, mixed) or agitation have been observed, which disappear when treatment is stopped.
Unknown frequency: aggression, psychotic disorders (delusion, delirium).
Impulse control disorders: Symptoms such as: pathological gambling (compulsive gambling), hypersexuality, increased libido, compulsive spending or shopping, excessive consumption of food and compulsive food disorders may appear in patients treated with dopaminergic agonists including TRIVASTAL (see Dosage & Administration and Precautions).
Nervous system disorders: Common: dizziness has been observed which disappears when treatment is stopped.
Unknown frequency dyskinesia.
Piribedil is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Cardiovascular disorders: Uncommon: hypotension, orthostatic hypotension, unstable blood pressure causing syncope or malaise.
General disorders and anomalies at the administration site: Unknown frequency: peripheral oedema.
Risk of allergic reactions due the presence of Cochineal red A (E124).