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REQUIP ropinirole

Get an overview of REQUIP (ropinirole tablet, film coated), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in REQUIP can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as REQUIP.

Drug Basics

Brand Name: REQUIP

Generic Name: ROPINIROLE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2019-03-11

indications & usage

parkinson’s disease

REQUIP is indicated for the treatment of Parkinson’s disease.

restless legs syndrome

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

drug interactions

cytochrome p450 1a2 inhibitors & inducers

In vitro metabolism studies showed that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of ropinirole. There is thus the potential for inducers or inhibitors of this enzyme to alter the clearance of ropinirole. Therefore, if therapy with a drug known to be a potent inducer or inhibitor of CYP1A2 is stopped or started during treatment with REQUIP, adjustment of the dose of REQUIP may be required. Coadministration of ciprofloxacin, an inhibitor of CYP1A2, increases the AUC and Cmax of ropinirole [see Clinical Pharmacology (12.3)]. Cigarette smoking is expected to increase the clearance of ropinirole since CYP1A2 is known to be induced by smoking [see Clinical Pharmacology (12.3)].

estrogens

Population pharmacokinetic analysis revealed that higher doses of estrogens (usually associated with hormone replacement therapy) reduced the clearance of ropinirole. Starting or stopping hormone replacement therapy may require adjustment of dosage of REQUIP [see Clinical Pharmacology (12.3)].

dopamine antagonists

Because ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes) or metoclopramide may reduce the efficacy of REQUIP.

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Dosing Instructions

Instruct patients to take REQUIP only as prescribed. If a dose is missed, advise patients not to double their next dose. REQUIP can be taken with or without food [see Dosage and Administration (2.1)].

Ropinirole is the active ingredient in both REQUIP XL and REQUIP tablets (the immediate‑release formulation). Ask your patients if they are taking another medication containing ropinirole.

Hypersensitivity/Allergic Reactions

Advise patients about the potential for developing a hypersensitivity/allergic reaction including manifestations such as urticaria, angioedema, rash, and pruritus when taking any ropinirole product. Inform patients who experience these or similar reactions to immediately contact their healthcare professional [see Contraindications (4)].

Falling Asleep during Activities of Daily Living and Somnolence

Alert patients to the potential sedating effects caused by REQUIP, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Because somnolence is a frequent adverse reaction with potentially serious consequences, patients should not drive a car, operate machinery, or engage in other potentially dangerous activities until they have gained sufficient experience with REQUIP to gauge whether or not it adversely affects their mental and/or motor performance. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., conversations, eating, driving a motor vehicle) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician.

Advise patients of possible additive effects when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants) in combination with REQUIP or when taking a concomitant medication (e.g., ciprofloxacin) that increases plasma levels of ropinirole [see Warnings and Precautions (5.1)].

Syncope and Hypotension/Orthostatic Hypotension

Advise patients that they may experience syncope and may develop hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating while taking REQUIP, especially if they are elderly. 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). Postural/orthostatic symptoms may be related to sitting up or standing. Accordingly, caution patients against standing 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 [see Warnings and Precautions (5.2, 5.3)].

Hallucinations/Psychotic-Like Behavior

Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations), and that other psychotic-like behavior can occur while taking REQUIP. The elderly are at greater risk than younger patients with Parkinson’s disease. This risk is greater in patients who are taking REQUIP with L-dopa or taking higher doses of REQUIP and may also be further increased in patients taking any other drugs that increase dopaminergic tone. Tell patients to report hallucinations or psychotic-like behavior to their healthcare provider promptly should they develop [see Warnings and Precautions (5.4)].

Dyskinesia

Inform patients that REQUIP may cause and/or exacerbate pre-existing dyskinesias [see Warnings and Precautions (5.5)].

Impulse Control/Compulsive Behaviors

Advise patients that they may experience impulse control and/or compulsive behaviors while taking 1 or more of the medications (including REQUIP) that increase central dopaminergic tone, that are generally used for the treatment of Parkinson’s disease. Advise patients to inform their physician or healthcare provider if they develop new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with REQUIP. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking REQUIP [see Warnings and Precautions (5.6)].

Withdrawal-Emergent Hyperpyrexia and Confusion

Advise patients to contact their healthcare provider if they wish to discontinue REQUIP or decrease the dose of REQUIP [see Warnings and Precautions (5.7)].

Melanoma

Advise patients with Parkinson’s disease that they have a higher risk of developing melanoma. Advise patients to have their skin examined on a regular basis by a qualified healthcare provider (e.g., dermatologist) when using REQUIP for any indication [see Warnings and Precautions (5.8)].

Augmentation and Rebound

Inform patients with RLS that augmentation and/or rebound may occur after starting treatment with REQUIP [see Warnings and Precautions (5.9)].

Nursing Mothers

Because of the possibility that ropinirole may be excreted in breast milk, discuss the developmental and health benefits of breastfeeding along with the mother’s clinical need for REQUIP and any potential adverse effects on the breastfed child from ropinirole or from the underlying maternal condition [see Use in Specific Populations (8.2)]. Advise patients that REQUIP could inhibit lactation because ropinirole inhibits prolactin secretion.

Pregnancy

Because experience with ropinirole in pregnant women is limited and ropinirole has been shown to have adverse effects on embryofetal development in animals, including teratogenic effects, advise patients of this potential risk. Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations (8.1)].

Trademarks are owned by or licensed to the GSK group of companies.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2018 GSK group of companies or its licensor.

REP:7PI

PATIENT INFORMATION

REQUIP (RE-qwip)

(ropinirole) tablets

REQUIP XL (RE-qwip)

(ropinirole) extended-release tablets

If you have Parkinson’s disease, read this side.

If you have Restless Legs Syndrome (RLS), read the other side.

Important Note: REQUIP XL has not been studied in RLS and is not approved for the treatment of RLS. However, an immediate-release form of ropinirole (REQUIP) is approved for the treatment of moderate to severe primary RLS (see other side of this leaflet).

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

REQUIP and REQUIP XL can cause serious side effects, including:

  • Falling asleep during normal activities. You may fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking REQUIP or REQUIP XL. You may suddenly fall asleep without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while doing normal activities while taking REQUIP or REQUIP XL are greater if you take other medicines that cause drowsiness. Tell your healthcare provider right away if this happens. Before starting REQUIP or REQUIP XL, be sure to tell your healthcare provider if you take any medicines that make you drowsy.
  • Fainting. Fainting can happen, and sometimes your heart rate may be decreased. This can happen especially when you start taking REQUIP or REQUIP XL or your dose is increased. Tell your healthcare provider if you faint, feel dizzy, or feel light-headed.
  • Decrease in blood pressure. REQUIP and REQUIP XL can decrease your blood pressure (hypotension), especially when you start taking REQUIP or REQUIP XL or when your dose is changed. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down (orthostatic hypotension), this may mean that your blood pressure is decreased. When you change position from lying down or sitting to standing up, you should do it carefully and slowly. Call your healthcare provider if you have any of the symptoms of decreased blood pressure listed above.
  • Increase in blood pressure. REQUIP XL may increase your blood pressure.
  • Changes in heart rate (decrease or increase). REQUIP and REQUIP XL can decrease or increase your heart rate.
  • Hallucinations and other psychotic-like behavior. REQUIP and REQUIP XL can cause or worsen psychotic-like behavior including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking. The chances of having hallucinations or these other psychotic-like changes are higher in people with Parkinson’s disease who are taking REQUIP or REQUIP XL or taking higher doses of these drugs. If you have hallucinations or any of these other psychotic-like changes, talk with your healthcare provider.
  • Uncontrolled sudden movements. REQUIP and REQUIP XL may cause uncontrolled sudden movements or make such movements you already have worse or more frequent. Tell your healthcare provider if this happens. The doses of your anti-Parkinson’s medicine may need to be changed.
  • Unusual urges. Some patients taking REQUIP or REQUIP XL get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble, increased sexual urges and behaviors, or an uncontrollable urge to shop, spend money, or eat. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider.
  • Increased chance of skin cancer (melanoma). People with Parkinson’s disease may have a higher chance of getting melanoma. It is not known if REQUIP and REQUIP XL increase your chances of getting melanoma. You and your healthcare provider should check your skin on a regular basis. Tell your healthcare provider right away if you notice any changes in your skin such as a change in the size, shape, or color of moles on your skin.

What are REQUIP and REQUIP XL?

  • REQUIP is a short-acting prescription medicine containing ropinirole (usually taken 3 times a day) that is used to treat Parkinson’s disease. It is also used to treat a condition called Restless Legs Syndrome (RLS).
  • REQUIP XL is a long-acting prescription medicine containing ropinirole (taken 1 time a day) that is used only to treat Parkinson’s disease but not to treat RLS.

Having one of these conditions does not mean you have or will develop the other condition.

You should not be taking more than 1 medicine containing ropinirole. Tell your healthcare provider if you are taking any other medicine containing ropinirole.

It is not known if REQUIP and REQUIP XL are safe and effective for use in children younger than 18 years of age.

Do not take REQUIP or REQUIP XL if you:

  • are allergic to ropinirole or any of the ingredients in REQUIP or REQUIP XL. See the end of this page for a complete list of the ingredients in REQUIP and REQUIP XL.
  •  Get help right away if any of the symptoms of an allergic reaction cause problems swallowing or breathing. Call your healthcare provider if you have any of the symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
  • hives
  • rash
  • swelling of the face, lips, mouth, tongue, or throat
  • itching

Before taking REQUIP or REQUIP XL, tell your healthcare provider about all of your medical conditions, including if you:

  • have daytime sleepiness from a sleep disorder or have unexpected or unpredictable sleepiness or periods of sleep.
  • start or stop taking other medicines while you are taking REQUIP or REQUIP XL. This may increase your chances of getting side effects.
  • start or stop smoking while you are taking REQUIP or REQUIP XL. Smoking may decrease the treatment effect of REQUIP or REQUIP XL.
  • feel dizzy, nauseated, sweaty, or faint when you stand up from sitting or lying down.
  • drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while taking REQUIP or REQUIP XL.
  • have high or low blood pressure.
  • have or have had heart problems.
  • are pregnant or plan to become pregnant. It is not known if REQUIP or REQUIP XL can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if REQUIP or REQUIP XL passes into your breast milk. The amount of breast milk you make may be decreased while taking REQUIP or REQUIP XL. Talk to your healthcare provider to decide if you should breastfeed while taking REQUIP or REQUIP XL.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of these medicines may increase your chances of getting side effects while taking REQUIP or REQUIP XL.

How should I take REQUIP or REQUIP XL?

  • Take REQUIP or REQUIP XL exactly as directed by your healthcare provider.
  • Take REQUIP or REQUIP XL with or without food.
  • Do not suddenly stop taking REQUIP or REQUIP XL without talking to your healthcare provider. If you stop this medicine suddenly, you may develop fever, confusion, or severe muscle stiffness.
  • Before starting REQUIP or REQUIP XL, you should talk to your healthcare provider about what to do if you miss a dose. If you have missed the previous dose and it is time for your next dose, do not double the dose.
  • Your healthcare provider will start you on a low dose of REQUIP or REQUIP XL. Your healthcare provider will change the dose until you are taking the right amount of medicine to control your symptoms. It may take several weeks before you reach a dose that controls your symptoms.
  • Contact your healthcare provider if you stop taking REQUIP or REQUIP XL for any reason. Do not restart without talking with your healthcare provider.
  • Your healthcare provider may prescribe REQUIP or REQUIP XL alone, or add REQUIP or REQUIP XL to medicine that you are already taking for Parkinson’s disease.
  • You should not substitute REQUIP for REQUIP XL or REQUIP XL for REQUIP without talking with your healthcare provider.

If you are taking REQUIP:

  • REQUIP tablets are usually taken 3 times a day for Parkinson’s disease.

If you are taking REQUIP XL:

  • Take REQUIP XL extended-release tablets 1 time each day for Parkinson’s disease, preferably at or around the same time of day.
  • Swallow REQUIP XL extended-release tablets whole. Do not chew, crush, or split REQUIP XL extended-release tablets.
  • REQUIP XL extended-release tablets release drug over a 24-hour period. If you have a condition where medicine passes through your body too quickly, such as diarrhea, the tablet(s) may not dissolve completely and you may see tablet residue in your stool. If this happens, let your healthcare provider know as soon as possible.

What are the possible side effects of REQUIP and REQUIP XL?

REQUIP and REQUIP XL can cause serious side effects, including:

  • See “What is the most important information I should know about REQUIP and REQUIP XL?”

The most common side effects of REQUIP and REQUIP XL include:
  • fainting
  • sleepiness or drowsiness
  • hallucinations (seeing or hearing things that are not real)
  • dizziness
  • nausea or vomiting
  • uncontrolled sudden movements
  • upset stomach, abdominal pain or discomfort
  • fatigue, tiredness, or weakness
  • confusion
  • headache
  • leg swelling
  • increased sweating
  • constipation
  • suddenly falling asleep
  • high blood pressure (hypertension)

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the possible side effects with REQUIP and REQUIP XL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store REQUIP or REQUIP XL?

  • Store REQUIP or REQUIP XL at room temperature between 68°F and 77°F (20°C and 25°C).
  • Keep REQUIP or REQUIP XL in a tightly closed container and out of direct sunlight.

Keep REQUIP or REQUIP XL and all medicines out of the reach of children.

General information about the safe and effective use of REQUIP or REQUIP XL.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use REQUIP or REQUIP XL for a condition for which it was not prescribed. Do not give REQUIP or REQUIP XL to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about REQUIP or REQUIP XL that is written for health professionals.

What are the ingredients in REQUIP and REQUIP XL?

The following ingredients are in REQUIP:

Active ingredient: ropinirole (as ropinirole hydrochloride)

Inactive ingredients: croscarmellose sodium, hydrous lactose, magnesium stearate, microcrystalline cellulose, and one 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.

The following ingredients are in REQUIP XL:

Active ingredient: ropinirole (as ropinirole hydrochloride)

Inactive ingredients: carboxymethylcellulose sodium, colloidal silicon dioxide, glycerol behenate, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mannitol, povidone, and one or more of the following: FD&C Yellow No. 6 aluminum lake, FD&C Blue No.2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 400, titanium dioxide.

 

PATIENT INFORMATION

REQUIP (RE-qwip)

(ropinirole) tablets

If you have Restless Legs Syndrome (RLS), read this side.

If you have Parkinson’s disease, read the other side.

Important Note: REQUIP XL has not been studied in RLS and is not approved for the treatment of RLS.

People with RLS should take REQUIP differently than people 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 people with RLS, and is taken once daily before bedtime.

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

REQUIP can cause serious side effects, including:

  • Falling asleep during normal activities. You may fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking REQUIP. You may suddenly fall asleep without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while doing normal activities while taking REQUIP are greater if you take other medicines that cause drowsiness. Tell your healthcare provider right away if this happens. Before starting REQUIP, be sure to tell your healthcare provider if you take any medicines that make you drowsy.
  • Fainting. Fainting can happen, and sometimes your heart rate may be decreased. This can happen especially when you start taking REQUIP or your dose is increased. Tell your healthcare provider if you faint, feel dizzy, or feel light-headed.
  • Decrease in blood pressure. REQUIP can decrease your blood pressure (hypotension), especially when you start taking REQUIP or when your dose is changed. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down (orthostatic hypotension), this may mean that your blood pressure is decreased. When you change position from lying down or sitting to standing up, you should do it carefully and slowly. Call your healthcare provider if you have any of the symptoms of decreased blood pressure listed above.
  • Hallucinations and other psychotic-like behavior. REQUIP can cause or worsen psychotic-like behavior including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking. If you have hallucinations or any of these other psychotic-like changes, talk with your healthcare provider.
  • Unusual urges. Some patients taking REQUIP get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble, increased sexual urges and behaviors, or an uncontrollable urge to shop, spend money, or eat. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider.
  • Increased chance of skin cancer (melanoma). It is not known if REQUIP increases your chance of getting melanoma. You and your healthcare provider should check your skin on a regular basis. Tell your healthcare provider right away if you notice any changes in your skin such as a change in the size, shape, or color of moles on your skin.
  • Changes in RLS symptoms. REQUIP may cause RLS symptoms to come back in the morning (rebound), happen earlier in the evening, or even happen in the afternoon.

What is REQUIP?

REQUIP is a prescription medicine containing ropinirole used to treat moderate-to-severe primary RLS. It is also used to treat Parkinson’s disease.

Having one of these conditions does not mean you have or will develop the other condition.

You should not be taking more than 1 medicine containing ropinirole. Tell your healthcare provider if you are taking any other medicine containing ropinirole.

It is not known if REQUIP is safe and effective for use in children younger than 18 years of age.

Do not take REQUIP if you:

  • are allergic to ropinirole or any of the ingredients in REQUIP. See the end of this page for a complete list of the ingredients in REQUIP.
  •  Get help right away if any of the symptoms of an allergic reaction cause problems swallowing or breathing. Call your healthcare provider if you have any of the symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
  • hives
  • rash
  • swelling of the face, lips, mouth, tongue, or throat
  • itching

Before taking REQUIP, tell your healthcare provider about all of your medical conditions, including if you:

  • have daytime sleepiness from a sleep disorder or have unexpected or unpredictable sleepiness or periods of sleep.
  • start or stop taking other medicines while you are taking REQUIP. This may increase your chances of getting side effects.
  • start or stop smoking while you are taking REQUIP. Smoking may decrease the treatment effect of REQUIP.
  • feel dizzy, nauseated, sweaty, or faint when you stand up from sitting or lying down.
  • drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while taking REQUIP.
  • have high or low blood pressure.
  • have or have had heart problems.
  • are pregnant or plan to become pregnant. It is not known if REQUIP can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if REQUIP passes into your breast milk. The amount of breast milk you make may be decreased while taking REQUIP. Talk to your healthcare provider to decide if you should breastfeed while taking REQUIP.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of these medicines may increase your chances of getting side effects while taking REQUIP.

How should I take REQUIP?

  • Take REQUIP exactly as directed by your healthcare provider.
  • REQUIP tablets are usually taken once in the evening, 1 to 3 hours before bedtime.
  • Take REQUIP with or without food.
  • Do not suddenly stop taking REQUIP without talking to your healthcare provider. If you stop this medicine suddenly, you may develop fever, confusion, or severe muscle stiffness.
  • Your healthcare provider will start you on a low dose of REQUIP. Your healthcare provider may change the dose until you are taking the right amount of medicine to control your symptoms.
  • 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 healthcare provider if you stop taking REQUIP for any reason. Do not restart without talking with your healthcare provider.

What are the possible side effects of REQUIP?

REQUIP can cause serious side effects, including:

  • See “What is the most important information I should know about REQUIP?”

The most common side effects of REQUIP include:
  • nausea or vomiting
  • drowsiness or sleepiness
  • dizziness
  • fatigue, tiredness, or weakness

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the possible side effects with REQUIP. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store REQUIP?

  • Store REQUIP at room temperature between 68°F and 77°F (20°C and 25°C).
  • Keep REQUIP in a tightly closed container and out of direct sunlight.

Keep REQUIP and all medicines out of the reach of children.

General information about the safe and effective use of REQUIP.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use REQUIP for a condition for which it was not prescribed. Do not give REQUIP to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about REQUIP that is written for health professionals.

What are the ingredients in REQUIP?

Active ingredient: ropinirole (as ropinirole hydrochloride)

Inactive ingredients: croscarmellose sodium, hydrous lactose, magnesium stearate, microcrystalline cellulose, and one 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.

For more information go to www.gsk.com or call 1-888-825-5249 (toll-free).

Trademarks are owned by or licensed to the GSK group of companies.

GlaxoSmithKline, Research Triangle Park, NC 27709

©2018 GSK group of companies or its licensor.

REP:6PIL

This Patient Information has been approved by the U.S. Food and Drug Administration                Revised: February 2018

PRINCIPAL DISPLAY PANEL

NDC 0007-4890-20

REQUIP®

(rOPINIRole tablets)

0.25 mg

100 Tablets

Rx only

Each tablet contains 0.29 mg ropinirole HCl equivalent to 0.25 mg ropinirole.

Store at controlled room temperature 20o - 25oC (68o - 77oF) [see USP].

Do not accept if seal on bottle opening is missing or broken.

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 12/16

10000000143764

requip spl graphic 02.jpg

PRINCIPAL DISPLAY PANEL

NDC 0007-4891-20

REQUIP®

(rOPINIRole tablets)

0.5 mg

100 Tablets

Rx only

Each tablet contains 0.57 mg ropinirole HCl equivalent to 0.5 mg ropinirole.

Store at controlled room temperature 20o to 25oC (68o to 77oF) [see USP].

Do not accept if seal on bottle opening is missing or broken.

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 11/16

10000000143765

requip spl graphic 03.jpg

PRINCIPAL DISPLAY PANEL

NDC 0007-4892-20

REQUIP®

(rOPINIRole tablets)

1 mg

100 Tablets

Rx only

Each tablet contains 1.14 mg ropinirole HCl equivalent to 1 mg ropinirole.

Store at controlled room temperature 20o - 25oC (68o - 77oF) [see USP].

Do not accept if seal on bottle opening is missing or broken.

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev.12/16

10000000143769

requip spl graphic 04.jpg

PRINCIPAL DISPLAY PANEL

NDC 0007-4893-20

REQUIP®

(rOPINIRole tablets)

2 mg

100 Tablets

Rx only

Each tablet contains 2.28 mg ropinirole HCl equivalent to 2 mg ropinirole.

Store at controlled room temperature 20o - 25oC (68o - 77oF) [see USP].

Do not accept if seal on bottle opening is missing or broken.

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 11/16

10000000143770

requip spl graphic 05.jpg

PRINCIPAL DISPLAY PANEL

NDC 0007-4895-20

REQUIP®

(rOPINIRole tablets)

3 mg

100 Tablets

Rx only

Each tablet contains 3.42 mg ropinirole HCl equivalent to 3 mg ropinirole.

Store at controlled room temperature 20o - 25oC (68o - 77oF) [see USP].

Do not accept if seal on bottle opening is missing or broken.

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 12/16

10000000143767

requip spl graphic 06.jpg

PRINCIPAL DISPLAY PANEL

NDC 0007-4896-20

REQUIP®

(rOPINIRole tablets)

4 mg

100 Tablets

Rx only

Each tablet contains 4.56 mg ropinirole HCl equivalent to 4 mg ropinirole.

Store at controlled room temperature 20o - 25oC (68o - 77oF) [see USP].

Do not accept if seal on bottle opening is missing or broken.

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 1/17

10000000143766

requip spl graphic 07.jpg

PRINCIPAL DISPLAY PANEL

NDC 0007-4894-20

REQUIP®

(rOPINIRole tablets)

5 mg

100 Tablets

Rx only

Each tablet contains 5.70 mg ropinirole HCl equivalent to 5 mg ropinirole.

Store at controlled room temperature 20o - 25oC (68o - 77oF) [see USP].

Do not accept if seal on bottle opening is missing or broken.

Protect from light and moisture. Close container tightly after each use.

Dosage: See Prescribing Information for complete dosing instructions.

GlaxoSmithKline

Research Triangle Park,

NC 27709

Made in Ireland

Rev. 11/16

10000000143768

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also known as
This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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