Requip IR

Requip IR Special Precautions

ropinirole

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
Due to the pharmacological action of ropinirole, patients with severe cardiovascular disease should be treated with caution.
Co-administration of ropinirole with anti-hypertensive and anti-arrhythmic agents has not been studied. As with other dopaminergic drugs, caution should be exercised when these compounds are given concomitantly with REQUIP because of the unknown potential for the occurrence of hypotension, bradycardias or other arrhythmias.
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) have been reported in patients treated with dopaminergic agents, including ropinirole (see Table 6 under 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.
Paradoxical worsening of Restless Legs Syndrome symptoms described as augmentation (either earlier onset, increased intensity, or spread of symptoms to previously unaffected limbs), or early morning rebound (reoccurrence of symptoms in the early morning hours), have been observed during treatment with ropinirole. If this occurs, the adequacy of ropinirole treatment should be reviewed and dosage adjustment or discontinuation of treatment may be considered.
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).
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 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.
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