PRESCRIBING INFORMATION
REQUIP® (ropinirole hydrochloride) Tablets
You should be careful until you know if Requip affects your ability to remain alert while doing normal daily activities, and you should watch for the development of significant daytime sleepiness or episodes of falling asleep. It is possible that you could fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking Requip. Your chances of falling asleep while doing normal activities while taking Requip are greater if you are taking other medicines that cause drowsiness.
A small number of patients taking medicines to treat Parkinson's disease, including Requip, have developed a problem with gambling. It is not known if this problem is directly related to the medicines or is due to other reasons. If you or your family notices that you have an unusual urge to gamble, talk to your doctor.
WARNINGS
Falling Asleep During Activities of Daily Living: Patients treated with Requip have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on Requip, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events have been reported as late as 1 year after initiation of treatment.
In controlled clinical trials, somnolence was a common occurrence in patients receiving Requip and is more frequent in Parkinson's disease (up to 40% Requip, 6% placebo) than in Restless Legs Syndrome (12% Requip, 6% placebo). Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities. Before initiating treatment with Requip, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with Requip such as concomitant sedating medications, the presence of sleep disorders (other than Restless Legs Syndrome), and concomitant medications that increase ropinirole plasma levels (e.g., ciprofloxacin--see PRECAUTIONS: Drug Interactions). If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.), Requip should ordinarily be discontinued. (See DOSAGE AND ADMINISTRATION for guidance in discontinuing Requip.) If a decision is made to continue Requip, patients should be advised to not drive and to avoid other potentially dangerous activities. There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.
Impulse Control Symptoms Including Compulsive Behaviors: Impulse control symptoms, including compulsive behaviors such as pathological gambling and hypersexuality, have been reported in patients treated with dopaminergic agents, including ropinirole. As described in the literature, such behaviors have been reported principally in Parkinson's disease patients treated with dopaminergic agents, especially at higher doses, and were generally reversible upon dose reduction or treatment discontinuation. In some cases with ropinirole, other factors were present such as a history of compulsive behaviors or concurrent dopaminergic treatment.
Nervous System Disorders: Frequent: Hypoesthesia, migraine. Infrequent: Amnesia, aphasia, ataxia, balance disorder, benign intracranial hypertension, burning sensation, carpal tunnel syndrome, disturbance in attention, dizziness postural, dysgeusia, dyskinesia, head discomfort, hyperesthesia, hypersomnia, lethargy, loss of consciousness, memory impairment, migraine with aura, migraine without aura, neuralgia, sciatica, sedation, sinus headache, sleep apnea syndrome, syncope vasovagal, tension headache, transient ischemic attack, tremor.
Psychiatric Disorders: Frequent: Anxiety, depression, irritability, sleep disorder. Infrequent: Abnormal dreams, agitation, bruxism, confusional state, depressed mood, disorientation, early morning awakening, libido decreased, loss of libido, mood swings, nervousness, nightmare, panic attack, stress symptoms, tension.
Physicians should instruct their patients to read the Patient Information leaflet before starting therapy with Requip and to reread it upon prescription renewal for new information regarding the use of Requip.