Requip Patient, Information, Instructions - Ropinirole

Requip Patient, Information, Instructions - Ropinirole INFORMATION FOR PATIENTS

Patients should be instructed to take Requip only as prescribed.

Requip can be taken with or without food. Since ingestion with food reduces the maximum concentration (C _max ) of Requip , patients should be advised that taking Requip with food may reduce the occurrence of nausea. However, this has not been established in controlled clinical trials.

Patients should be informed that hallucinations can occur, and that the elderly are at a higher risk than younger patients with Parkinson's disease.

Patients should be advised that they may develop postural (orthostatic) hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Accordingly, patients should be cautioned against rising rapidly after sitting or lying down, especially if they have been doing so for prolonged periods, and especially at the initiation of treatment with Requip .

Patients should be alerted to the potential sedating effects associated with Requip including somnolence and the possibility of falling asleep while engaged in activities of daily living. Since somnolence is a frequent adverse event with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with Requip to gauge whether or not it affects their mental and/or motor performance adversely. Patients should be advised that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Because of possible additive effects, caution should be advised when patients are taking other sedating medications or alcohol in combination with Requip and when taking concomitant medications that increase plasma levels of ropinirole (e.g., ciprofloxacin).

Because of the possible additive sedative effects, caution should also be used when patients are taking alcohol or other CNS depressants (e.g., benzodiazepines, antipsychotics, antidepressants, etc.) in combination with Requip .

Because of the possibility that ropinirole may be excreted in breast milk, patients should be advised to notify their physicians if they intend to breast-feed or are breast-feeding an infant.

Because ropinirole has been shown to have adverse effects on embryo-fetal development, including teratogenic effects, in animals, and because experience in humans is limited, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy (see PRECAUTIONS , Pregnancy).