Requip 4mg by Requip in Prescription Drugs

Requip
Requip 4mg
Tablet

Also sold as Brand(s): Requip Xl
Also sold as Generic: Ropinirole Hydrochloride

REQUIP (ropinirole hydrochloride) is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of... more

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Requip 4mg Overview

Requip Description

REQUIP (ropinirole hydrochloride) is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an empirical formula of C16 H24 N2 O?HCl. The molecular weight is 296.84 (260.38 as the free base).

The structural formula is:

Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water.

Each pentagonal film-coated TILTABŽ tablet with beveled edges contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, hydrous lactose, magnesium stearate, microcrystalline cellulose, andone or more of the following: carmine, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake, hypromellose, iron oxides, polyethylene glycol, polysorbate 80, titanium dioxide.

Requip Indications And Usage

Parkinson?s Disease

REQUIP is indicated for the treatment of the signs and symptoms of idiopathic Parkinson?s disease.

The effectiveness of REQUIP was demonstrated in randomized, controlled trials in patients with early Parkinson?s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).

Restless Legs Syndrome

REQUIP is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.

Requip Contraindications

REQUIP is contraindicated for patients known to have hypersensitivity to the product.

Requip Side Effects

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 driveand 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.

Syncope

Syncope, sometimes associated with bradycardia, was observed in association with ropinirole in both Parkinson?s disease patients and RLS patients. In the 2 double-blind, placebo-controlled studies of REQUIP in patients with Parkinson?s disease who were not being treated with L-dopa, 11.5% (18 of 157) of patients on REQUIP had syncope compared to 1.4% (2 of 147) of patients on placebo. Most of these cases occurred more than 4 weeks after initiation of therapy with REQUIP, and were usually associated with a recent increase in dose.

Of 208 patients being treated with both L-dopa and REQUIP in placebo-controlled advanced Parkinson?s disease trials, there were reports of syncope in 6 (2.9%) compared to 2 of 120 (1.7%) of placebo/L-dopa patients.

In patients with RLS, of 496 patients treated with REQUIP in 12-week placebo-controlled trials, there were reports of syncope in 5 (1.0%) compared with 1 of 500 (0.2%) patients treated with placebo.

Because the studies of REQUIP excluded patients with significant cardiovascular disease, it is not known to what extent the estimated incidence figures apply to either Parkinson?s disease or RLS patients in clinical practice. Therefore, patients with severe cardiovascular disease should be treated with caution.

Two of 47 Parkinson?s disease patient volunteers enrolled in phase 1 studies had syncope following a 1-mg dose. In 2 studies in RLS patients that used a forced titration regimen and orthostatic challenge with intensive blood pressure monitoring, 1 of 55 RLS patients treated with REQUIP compared with 0 of 27 patients receiving placebo reported syncope. In phase 1 studies including 110 healthy volunteers, 1 patient developed hypotension, bradycardia, and sinus arrest of 26 seconds accompanied by syncope; the patient recovered spontaneously without intervention. One other healthy volunteer reported syncope.

Symptomatic Hypotension

Dopamine agonists, in clinical studies and clinical experience, appear to impair the systemic regulation of blood pressure, with resulting postural hypotension, especially during dose escalation. Parkinson?s disease patients, in addition, appear to have an impaired capacity to respond to a postural challenge. For these reasons, Parkinson?s patients being treated with dopaminergic agonists ordinarily (1) require careful monitoring for signs and symptoms of postural hypotension, especially during dose escalation, and (2) should be informed of this risk (see PRECAUTIONS: Information for Patients).

Although the clinical trials were not designed to systematically monitor blood pressure, there were individual reported cases of postural hypotension in early Parkinson?s disease (without L-dopa) in patients treated with REQUIP. Most of these cases occurred more than 4 weeks after initiation of therapy with REQUIP and were usually associated with a recent increase in dose.

In 12-week placebo-controlled trials of patients with RLS, the adverse event orthostatic hypotension was reported by 4 of 496 patients (0.8%) treated with REQUIP compared with 2 of 500 patients (0.4%) receiving placebo.

In two phase 2 studies in patients with RLS that used a forced-titration regimen and orthostatic challenges with intensive blood pressure monitoring, 14 of 55 patients (25%) receiving REQUIP experienced an adverse event of hypotension or postural hypotension. As described above, one additional patient was noted to have an episode of vasovagal syncope (although no blood pressure recording was documented). None of the 27 patients receiving placebo had a similar adverse event. In these studies, 11 of the 55 patients (20%) receiving REQUIP and 3 of the 26 patients (12%) who had post-dose blood pressure assessments following placebo, experienced an orthostatic blood pressure decrease of at least 40 mm Hg systolic and/or at least 20 mm Hg diastolic; not all of these changes were associated with clinical symptoms. Except for its forced nature these studies used a similar titration schedule as those in the phase 3 efficacy trials.

In phase 1 studies of REQUIP that included 110 healthy volunteers, 9 subjects had documented symptomatic postural hypotension. These episodes appeared mainly at doses above 0.8 mg and these doses are higher than the starting doses recommended for either Parkinson?s disease patients or RLS patients. In 8 of these 9 individuals, the hypotension was accompanied by bradycardia, but did not develop into syncope (see Syncope subsection). None of these events resulted in death or hospitalization.

One of 47 Parkinson?s disease patient volunteers enrolled in phase 1 studies had documented hypotension following a 2-mg dose on 2 occasions.

Hallucinations

In double-blind, placebo-controlled, early-therapy studies in patients with Parkinson?s disease who were not treated with L-dopa, 5.2% (8 of 157) of patients treated with REQUIP reported hallucinations, compared to 1.4% of patients on placebo (2 of 147). Among those patients receiving both REQUIP and L-dopa in advanced Parkinson?s disease (with L-dopa) studies, 10.1% (21 of 208) were reported to experience hallucinations, compared to 4.2% (5 of 120) of patients treated with placebo and L-dopa.

Hallucinations were of sufficient severity to cause discontinuation of treatment in 1.3% of the early Parkinson?s disease (without L-dopa) patients and 1.9% of the advanced Parkinson?s disease (with L-dopa) patients, compared to 0% and 1.7% of placebo patients, respectively.

In patients with RLS, hallucinations were reported by 0% of patients treated with REQUIP (0 of 496) compared with 0.2% of patients who received placebo (1 of 500) in the 12-week placebo-controlled trials; in premarketing long-term open-label studies, 0.5% of patients reported hallucinations during therapy with REQUIP (2 of 390) but did not discontinue treatment and symptoms resolved.

Requip Precautions

General

Dyskinesia

REQUIP may potentiate the dopaminergic side effects of L-dopa and may cause and/or exacerbate preexisting dyskinesia in patients treated with L-dopa for Parkinson's disease. Decreasing the dose of L-dopa may ameliorate this side effect.

Renal Impairment

No dosage adjustment is needed in patients with mild to moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The use of REQUIP in patients with severe renal impairment has not been studied.

Hepatic Impairment

The pharmacokinetics of ropinirole have not been studied in patients with hepatic impairment. Since patients with hepatic impairment may have higher plasma levels and lower clearance, REQUIP should be titrated with caution in these patients.

Events Reported With Dopaminergic Therapy

Withdrawal-emergent Hyperpyrexia and Confusion

Although not reported with REQUIP, a symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in anti-Parkinsonian therapy.

Fibrotic Complications

Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis, and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents. While these complications may resolve when the drug is discontinued, complete resolution does not always occur.

Although these adverse events are believed to be related to the ergoline structure of these compounds, whether other, nonergot-derived dopamine agonists can cause them is unknown.

A small number of reports have been received of possible fibrotic complications, including pleural effusion, pleural fibrosis, interstitial lung disease, and cardiac valvulopathy, in the development program and postmarketing experience for REQUIP. While the evidence is not sufficient to establish a causal relationship between REQUIP and these fibrotic complications, a contribution of REQUIP cannot be completely ruled out in rare cases.

Melanoma

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. REQUIP is one of the dopamine agonists used to treat Parkinson?s disease. Although REQUIP 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 for any indication should be made aware of these results and should undergo periodic dermatologic screening.

Augmentation and Rebound In Rls

Reports in the literature indicate treatment of RLS with dopaminergic medications can result in a worsening of symptoms in the early morning hours, referred to as rebound. Augmentation has also been described during therapy for RLS. Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities. The controlled trials of REQUIP in patients with RLS excluded patients with augmentation and rebound and were generally not of sufficient duration to capture these phenomena. The frequency of augmentation and/or rebound after longer use of REQUIP and the appropriate management of these events, have not been evaluated in controlled clinical trials.

Impulse Control Symptoms Including Compulsive Behaviors

Impulse control symptoms, including compulsive behaviorssuch 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.

Retinal Pathology

Albino Rats

Retinal degeneration was observed in albino rats in the 2-year carcinogenicity study at all doses tested (equivalent to 0.6 to 20 times the maximum recommended human dose on a mg/m2 basis), but was statistically significant at the highest dose (50 mg/kg/day). Additional studies to further evaluate the specific pathology (e.g., loss of photoreceptor cells) have not been performed. Similar changes were not observed in a 2-year carcinogenicity study in albino mice or in rats or monkeys treated for 1 year. The potential significance of this effect in humans has not been established, but cannot be disregarded because disruption of a mechanism that is universally present in vertebrates (e.g., disk shedding) may be involved.

Human

In order to evaluate the effect of REQUIP in humans, ocular electroretinogram (ERG) assessments were conducted during a 2-year, double-blind, multicenter, flexible dose, L-dopa controlled clinical study of REQUIP in patients with Parkinson's disease. A total of 156 patients (78 on ropinirole, mean dose 11.9 mg/day and 78 on L-dopa, mean dose 555.2 mg/day) were evaluated for evidence of retinal dysfunction through electroretinograms. There was no clinically meaningful difference between the treatment groups in retinal function over the duration of the study.

Binding To Melanin

REQUIP binds to melanin-containing tissues (i.e., eyes, skin) in pigmented rats. After a single dose, long-term retention of drug was demonstrated, with a half-life in the eye of 20 days. It is not known if REQUIP accumulates in these tissues over time.

Information For Patients

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.

Patients should be instructed to take REQUIP only as prescribed. If a dose is missed, patients should be advised not to double their next dose.

REQUIP can be taken with or without food. Patients may 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 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.

Patients should be informed they may experience hallucinations (unreal visions, sounds, or sensations) while taking REQUIP. These were uncommon in patients taking REQUIP for Restless Legs Syndrome. The risk is greater in patients with Parkinson's disease; the elderly are at greater risk than younger patients with Parkinson's disease; and the risk is greater in patients who are taking REQUIP with L-dopa, or taking higher doses of REQUIP.

Patients should be informed that some patients taking ropinirole have shown urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and/or behaviors. If patients or their family notice that they are developing any unusual behaviors, they should talk to their doctor.

Because of the possibility that ropinirole may be excreted in breast milk, patients should be advised to notify their physicians if they intend to breastfeed or are breastfeeding 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).

Drug Interactions

P450 Interaction

In vitro metabolism studies showed that CYP1A2 was the major enzyme responsible for the metabolism of ropinirole. There is thus the potential for substrates or inhibitors of this enzyme when coadministered with ropinirole to alter its clearance. Therefore, if therapy with a drug known to be a potent inhibitor of CYP1A2 is stopped or started during treatment with REQUIP, adjustment of the dose of REQUIP may be required.

L-dopa

Co-administration of carbidopa + L-dopa (SINEMETŽ 10/100 mg twice daily) with ropinirole (2 mg 3 times daily) had no effect on the steady-state pharmacokinetics of ropinirole (n = 28 patients). Oral administration of REQUIP 2 mg 3 times daily increased mean steady state Cmax of L-dopa by 20%, but its AUC was unaffected (n = 23 patients).

Digoxin

Co-administration of REQUIP (2 mg 3 times daily) with digoxin (0.125 to 0.25 mg once daily) did not alter the steady-state pharmacokinetics of digoxin in 10 patients.

Theophylline

Administration of theophylline (300 mg twice daily, a substrate of CYP1A2) did not alter the steady-state pharmacokinetics of ropinirole (2 mg 3 times daily) in 12 patients with Parkinson?s disease. Ropinirole (2 mg 3 times daily) did not alter the pharmacokinetics of theophylline (5 mg/kg IV) in 12 patients with Parkinson?s disease.

Ciprofloxacin

Co-administration of ciprofloxacin (500 mg twice daily), an inhibitor of CYP1A2, with ropinirole (2 mg 3 times daily) increased ropinirole AUC by 84% on average and Cmax by 60% (n = 12 patients).

Estrogens

Population pharmacokinetic analysis revealed that estrogens (mainly ethinylestradiol: intake 0.6 to 3 mg over 4-month to 23-year period) reduced the oral clearance of ropinirole by 36% in 16 patients. Dosage adjustment may not be needed for REQUIP in patients on estrogen therapy because patients must be carefully titrated with ropinirole to tolerance oradequate effect. However, if estrogen therapy is stopped or started during treatment with REQUIP, then adjustment of the dose of REQUIP may be required.

Dopamine Antagonists

Since ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide may diminish the effectiveness of REQUIP. Patients with major psychotic disorders treated with neuroleptics should only be treated with dopamine agonists if the potential benefits outweigh the risks.

Population analysis showed that commonly administered drugs, e.g., selegiline, amantadine, tricyclic antidepressants, benzodiazepines, ibuprofen, thiazides, antihistamines, and anticholinergics, did not affect the oral clearance of ropinirole.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Two-year carcinogenicity studies were conducted in Charles River CD-1 mice at doses of 5, 15, and 50 mg/kg/day and in Sprague-Dawley rats at doses of 1.5, 15, and 50 mg/kg/day (top doses equivalent to 10 and 20 times, respectively, the maximum recommended human dose of 24 mg/day on a mg/m2 basis). In the male rat, there was a significant increase in testicular Leydig cell adenomas at all doses tested, i.e., ?1.5 mg/kg (0.6 times the maximum recommended human dose on a mg/m2 basis). This finding is of questionable significance because the endocrine mechanisms believed to be involved in the production of Leydig cell hyperplasia and adenomas in rats are not relevant to humans. In the female mouse, there was an increase in benign uterine endometrial polyps at a dose of 50 mg/kg/day (10 times the maximum recommended human dose on a mg/m2 basis).

Ropinirole was not mutagenic or clastogenic in the in vitro Ames test, the in vitro chromosome aberration test in human lymphocytes, the in vitro mouse lymphoma (L1578Y cells) assay, and the in vivo mouse micronucleus test.

When administered to female rats prior to and during mating and throughout pregnancy, ropinirole caused disruption of implantation at doses of 20 mg/kg/day (8 times the maximum recommended human dose on a mg/m2 basis) or greater. This effect is thought to be due to the prolactin-lowering effect of ropinirole. In humans, chorionic gonadotropin, not prolactin, is essential for implantation. In rat studies using low doses (5 mg/kg) during the prolactin-dependent phase of early pregnancy (gestation days 0 to 8), ropinirole did not affect female fertility at dosages up to 100 mg/kg/day (40 times the maximum recommended human dose on a mg/m2 basis). No effect on male fertility was observed in rats at dosages up to 125 mg/kg/day (50 times the maximum recommended human dose on a mg/m2 basis).

Pregnancy

Pregnancy Category C. In animal reproduction studies, ropinirole has been shown to have adverse effects on embryo-fetal development, including teratogenic effects. Ropinirole given to pregnant rats during organogenesis (20 mg/kg on gestation days 6 and 7 followed by 20, 60, 90, 120, or 150 mg/kg on gestation days 8 through 15) resulted in decreased fetal body weight at 60 mg/kg/day, increased fetal death at 90 mg/kg/day, and digital malformations at 150 mg/kg/day (24, 36, and 60 times the maximum recommended clinical dose on a mg/m2 basis, respectively). The combined administration of ropinirole (10 mg/kg/day, 8 times the maximum recommended human dose on a mg/m2 basis) and L-dopa (250 mg/kg/day) to pregnant rabbits during organogenesis produced a greater incidence and severity of fetal malformations (primarily digit defects) than were seen in the offspring of rabbits treated with L-dopa alone. No indication of an effect on development of the conceptus was observed in rabbits when a maternally toxic dose of ropinirole was administered alone (20 mg/kg/day, 16 times the maximum recommended human dose on a mg/m2 basis). In a perinatal-postnatal study in rats, 10 mg/kg/day (4 times the maximum recommended human dose on a mg/m2 basis) of ropinirole impaired growth and development of nursing offspring and altered neurological development of female offspring.

There are no adequate and well-controlled studies using REQUIP in pregnant women. REQUIP should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Nursing Mothers

REQUIP inhibits prolactin secretion in humans and could potentially inhibit lactation.

Studies in rats have shown that REQUIP and/or its metabolite(s) is excreted in breast milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from REQUIP, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Requip Overdosage

In the Parkinson's disease program, there have been patients who accidentally or intentionally took more than their prescribed dose of ropinirole. The largest overdose reported in the Parkinson's disease clinical trials was 435 mg taken over a 7-day period (62.1 mg/day). Of patients who received a dose greater than 24 mg/day, reported symptoms included adverse events commonly reported during dopaminergic therapy (nausea, dizziness), as well as visual hallucinations, hyperhidrosis, claustrophobia, chorea, palpitations, asthenia, and nightmares. Additional symptoms reported for doses of 24 mg or less or for overdoses of unknown amount included vomiting, increased coughing, fatigue, syncope, vasovagal syncope, dyskinesia, agitation, chest pain, orthostatic hypotension, somnolence, and confusional state.

Overdose Management

It is anticipated that the symptoms of overdose with REQUIP will be related to its dopaminergic activity. General supportive measures are recommended. Vital signs should be maintained, if necessary. Removal of any unabsorbed material (e.g., by gastric lavage) should be considered.

Requip Patient Information

REQUIP Ž (ropinirole hydrochloride) Tablets

If You Have Restless Legs Syndrome (Rls, Also Known As Ekbom Syndrome), Read This Side

Read this information completely before you start taking REQUIP . Read the information each time you get more medicine. There may be new information. This leaflet provides a summary about REQUIP. It does not include everything there is to know about your medicine. This information should not take the place of discussions with your doctor about your medical condition or REQUIP.

What is REQUIP?

REQUIP is a prescription medicine to treat moderate-to-severe primary Restless Legs Syndrome. It is sometimes used to treat Parkinson's disease. Having one of these conditions does not mean you have or will develop the other.

What is the most important information I should know about REQUIP?

Patients with RLS should take REQUIP differently than patients with Parkinson's disease (see How should I take REQUIP for RLS? for the recommended dosing for RLS). A lower dose of REQUIP is generally needed for patients with RLS, and is taken once daily before bedtime.
There are known side effects of REQUIP. If you fall asleep or feel very sleepy while doing normal activities such as driving, faint, feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, you should talk with your doctor (see What are the possible side effects of REQUIP? ).
Before starting REQUIP, be sure to tell your doctor if you are taking any medicines that make you drowsy.

Who should not take REQUIP?

You should not take REQUIP if you are allergic to the active ingredient ropinirole or to any of the inactive ingredients. Your doctor and pharmacist have a list of the inactive ingredients.

What should I tell my doctor?

Be sure to tell your doctor if:

you are pregnant or plan to become pregnant.
you are breast-feeding.
you have daytime sleepiness from a sleep disorder other than RLS or have unexpected sleepiness or periods of sleep while taking REQUIP.
you are taking any other prescription or over-the-counter medicines. Some of these medicines may increase your chances of getting side effects while taking REQUIP.
you start or stop taking other medicines while you are taking REQUIP. This may increase your chances of getting side effects.
you start or stop smoking while you are taking REQUIP. Smoking may decrease the treatment effect of REQUIP.
you feel dizzy, nauseated, sweaty, or faint when you stand up from sitting or lying down.
you drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while taking REQUIP.

How should I take REQUIP for RLS?

Be sure to take REQUIP exactly as directed by your doctor or healthcare provider.
The usual way to take REQUIP is once in the evening, 1 to 3 hours before bedtime.
Your doctor will start you on a low dose of REQUIP. Your doctor may change the dose until you are taking the amount of medicine that is right for you to control your symptoms.
You may receive a starting kit with doses marked by day. The pills in this kit slowly increase your daily dose over time so that you and your doctor may determine what the best dose is for you. Different people respond differently to this medicine. You may not need the highest dose pill in this kit or you may need an even higher dose to relieve your symptoms. You should carefully follow your doctor?s advice on the use of this kit.
If you miss your dose, do not double your next dose . Take only your usual dose 1 to 3 hours before your next bedtime.
Contact your doctor, if you stop taking REQUIP for any reason. Do not restart without consulting your doctor.
You can take REQUIP with or without food. Taking REQUIP with food may decrease the chances of feeling nauseated.

What are the possible side effects of REQUIP?

Most people who take REQUIP tolerate it well. The most commonly reported side effects in people taking REQUIP for RLS are nausea, vomiting, dizziness, and drowsiness or sleepiness. 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.
When you start taking REQUIP or when you increase your dose, you may feel dizzy, nauseated, sweaty or faint, when first standing up from sitting or lying down. Therefore, do not stand up quickly after sitting or lying down, particularly if you have been sitting or lying down for a long period of time. Take a minute sitting on the edge of the bed or chair before you get up.
Some patients taking ropinirole have shown urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and/or behaviors. If you or your family notices that you are developing any unusual behaviors, talk to your doctor.
Hallucinations (unreal sounds, visions, or sensations) have been reported in patients taking REQUIP. These were uncommon in patients taking REQUIP for RLS. The risk is greater in patients with Parkinson's disease who are elderly, taking REQUIP with L-dopa, or taking higher doses of REQUIP than recommended for RLS.

This is not a complete list of side effects and should not take the place of discussions with your healthcare providers. Your doctor or pharmacist can give you a more complete list of possible side effects. Talk to your doctor about any side effects or problems you may have.

Other Information about REQUIP

Studies of people with Parkinson?s disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson?s disease. It is not known if this problem is associated with Parkinson?s disease or the medicines used to treat Parkinson?s disease. REQUIP is one of the medicines used to treat Parkinson?s disease, therefore, patients being treated with REQUIP should have periodic skin examinations.
Take REQUIP exactly as your doctor prescribes it.
Do not share REQUIP with other people, even if they have the same symptoms you have.
Keep REQUIP out of the reach of children.
Store REQUIP at room temperature out of direct sunlight.
Keep REQUIP in a tightly closed container.

This leaflet summarizes important information about REQUIP. Medicines are sometimes prescribed for purposes other than those listed in this leaflet. Do not take REQUIP for a condition for which it was not prescribed. For more information, talk with your doctor or pharmacist. They can give you information about REQUIP that is written for healthcare professionals.

GlaxoSmithKline

Research Triangle Park, NC 27709

October 2006 RQ:L15

PATIENT INFORMATION

REQUIP Ž (ropinirole hydrochloride)Tablets

If You Have Parkinson's Disease, Read This Side