ReQuip PD 24 Hour

ReQuip PD 24 Hour Special Precautions

ropinirole

Manufacturer:

GlaxoSmithKline Indonesia
Full Prescribing Info
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 symptoms including compulsive behaviours (including pathological gambling, hypersexuality, compulsive shopping and binge eating) and mania have been reported in patients treated with dopaminergic agents, including ropinirole (see Adverse Reactions). These were generally reversible upon dose reduction or treatment discontinuation. In some ropinirole cases, other factors were present such as a history of compulsive behaviours or concurrent dopaminergic treatment.
Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ropinirole PR 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: REQUIP PD 24 HOUR 4 mg tablets contain sunset yellow FCF (E110 or FD&C Yellow No 6) which may cause allergic-type 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 have 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.
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