Important
Safety Information
REQUIP XL Tablets have been associated with sedating effects, including somnolence, and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. REQUIP XL should ordinarily be discontinued if these events occur; it is unknown if dose reduction will eliminate episodes of somnolence. Prescribers should reassess patients for somnolence throughout treatment.
Syncope or symptomatic hypotension may occur, particularly during initial treatment or dose titration. Patients should be cautioned against rising rapidly after sitting or lying down. Elevation of blood pressure and changes in heart rate may also occur.
Because of possible additive effects, caution should be exercised with patients who have sleep disorders or are taking sedating medications, alcohol, CNS depressants, or medications that increase ropinirole plasma levels.
Hallucinations may occur at any time during treatment. REQUIP XL may potentiate the dopaminergic side effects of L-dopa and may cause and/or exacerbate pre-existing dyskinesias.
Patients should be informed that impulse control symptoms, including compulsive behaviors such as pathological gambling and hypersexuality, have been reported in patients treated with dopaminergic agents, including ropinirole. Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped.
Some epidemiologic studies have shown that patients with Parkinson’s disease have a higher risk (perhaps 2- to 4-fold higher) of developing melanoma than the general population. Whether the observed increased risk was due to Parkinson’s disease or other factors, such as drugs used to treat Parkinson’s disease, was unclear.
Although REQUIP XL has not been associated with an increased risk of melanoma specifically, its potential role as a risk factor has not been systematically studied. Patients using REQUIP XL should be made aware of these results and should undergo periodic dermatologic screening.