Requip PD 24 Hour Special Precautions

Due to the pharmacological action of ropinirole, patients with severe cardiovascular disease should be treated with caution.
Patients with a history or presence of major psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
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 REQUIP PD 24 HOUR prolonged-release tablets. Dose reduction/tapered discontinuation should be considered if such symptoms develop. Impulse control disorders were reported especially at high doses and were generally reversible upon reduction of the dose or treatment discontinuation. Risk factors such as a history of compulsive behaviours were present in some cases. Ropinirole 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 uncommonly. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with ropinirole. 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.
REQUIP PD 24 HOUR prolonged-release tablets are designed to release medication over a 24 hour period. If rapid gastrointestinal transit occurs, there may be risk of incomplete release of medication, and of medication residue being passed in the stool.
The dose of ropinirole should be reduced gradually when discontinuing treatment (see Dosage & Administration). Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists, including ropinirole. Symptoms include insomnia, apathy, anxiety, depression, fatigue, sweating and pain which may be severe. Patients should be informed about this before dose reduction and monitored regularly thereafter. In case of persistent symptoms, it may be necessary to increase the ropinirole dose temporarily (see Adverse Reactions).
Excipients: This medicinal product also contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
REQUIP PD 24 HOUR 4 mg tablets contain sunset yellow FCF (E110 or FD&C Yellow No 6), which may cause allergic reactions.
Effects on Ability to Drive and Use Machines: No data are available on the effect of ropinirole on the ability to drive or use machinery. Patients should be cautioned about their ability to drive or operate machinery whilst taking REQUIP PD 24 HOUR because of the possibility of somnolence and of dizziness (including vertigo).
Patients should be informed about the possibility of sudden onset of sleep without any prior warning or apparent daytime somnolence (see Adverse Reactions), which has primarily been observed in patients with Parkinson's disease, and should be cautioned that their safety and that of others is at risk should this happen when driving or operating machinery. If patients develop significant daytime sleepiness or episodes of falling asleep during activities that require active participation, patients should be told not to drive and to avoid other potentially dangerous activities.