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Home » Anti-Parkinson Drugs, Restless Legs Syndrome

REQUIP® & REQUIP XL® – Ropinirole

Submitted by on November 28, 2016 – 12:03 pm | 109 views
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REQUIP® & REQUIP XL® – Ropinirole

REQUIP® (RE-qwip) (ropinirole) Tablets

REQUIP XL® (RE-qwip) (ropinirole) Extended-release Tablets

PATIENT INFORMATION

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).

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

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

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

  • /allergic reactions. You may experience a /allergic reaction characterized by , rash, itching, and/or swelling of the face, lips, mouth, tongue, or throat, which may cause problems in swallowing or breathing. If you experience any of these reactions, you should not take REQUIP or REQUIP XL again until you talk to a healthcare provider and seek their advice.
  • 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.
  • . 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 or or light-headed.
  • Decrease in blood pressure. REQUIP and REQUIP XL can decrease your blood pressure. Decreases in your blood pressure (hypotension) can happen, 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.
  • and other psychotic-like behavior. REQUIP and REQUIP XL can cause or worsen psychotic-like behavior including (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 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 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.

Who should not take REQUIP or REQUIP XL?

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.

Call your healthcare provider and get help right away if you have any of the following symptoms of an allergic reaction. Symptoms of an allergic reaction may include:

  • hives
  • rash
  • swelling of the face, lips, mouth, tongue, or throat
  • itching

What should I tell my healthcare provider before taking REQUIP or REQUIP XL?

Before you take REQUIP or REQUIP XL, tell your healthcare provider if you:

  • have daytime sleepiness from a sleep disorder or have unexpected or unpredictable sleepiness or periods of sleep.
  • 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 or REQUIP XL.
  • 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. REQUIP or REQUIP XL may harm your unborn baby. REQUIP and REQUIP XL should only be used during pregnancy if needed.
  • are breastfeeding or plan to breastfeed. It is not known if REQUIP or REQUIP XL passes into your breast milk, and the amount of breast milk you produce may be decreased while taking REQUIP or REQUIP XL. You and your healthcare provider should decide if you should take REQUIP or REQUIP XL while breastfeeding.
  • have any other medical conditions.

How should I take REQUIP or REQUIP XL for Parkinson’s disease?

  • Take REQUIP or REQUIP XL exactly as directed by your healthcare provider.
  • 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.

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.

If you are taking either REQUIP or REQUIP XL:

  • 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.
  • You can take REQUIP or REQUIP XL with or without food.

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)
  • or vomiting
  • uncontrolled sudden movements
  • leg swelling
  • fatigue, , or weakness
  • confusion
  • headache
  • upset stomach, abdominal pain or discomfort
  • increased sweating

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

This is not a complete list of side effects and should not take the place of talking with your healthcare provider. Your healthcare provider or pharmacist can give you a more complete list of possible side effects.

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 and REQUIP XL?

  • Store REQUIP or REQUIP XL at room temperature between 68°F to 77°F (20°C to 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 and REQUIP XL.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take 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 you have. It may harm them.

This side of the patient information leaflet summarizes the most important information about REQUIP and REQUIP XL for Parkinson’s disease. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about REQUIP and REQUIP XL that is written for healthcare professionals. For more information go to www.gsk.com or call 1-888-825-5249 (toll-free).

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.

REQUIP® (RE-qwip) (ropinirole) Tablets

PATIENT INFORMATION

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 Restless Legs Syndrome (RLS) and is not approved for the treatment of RLS.

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 healthcare provider about your medical condition or treatment with REQUIP.

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 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:

  • Hypersensitivity/allergic reactions. You may experience a hypersensitivity/allergic reaction characterized by hives, rash, itching, and/or swelling of the face, lips, mouth, tongue, or throat, which may cause problems in swallowing or breathing. If you experience any of these reactions after starting REQUIP, you should not take REQUIP again until you talk to a healthcare provider and seek their advice.
  • 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 occur, 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 or feel dizzy or 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 feel 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.
  • Changes in heart rate (decrease or increase). REQUIP can decrease or increase your heart rate.
  • 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 Restless Legs Syndrome symptoms. REQUIP may cause Restless Legs 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 Restless Legs Syndrome (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.

Who should not take REQUIP?

Do not take REQUIP if you:

  • are allergic to ropinirole or any of the ingredients in REQUIP. See the end of this leaflet for a complete list of the ingredients in REQUIP.

Call your healthcare provider and get help right away if you have any of the following symptoms of an allergic reaction. Symptoms of an allergic reaction may include:

  • hives
  • rash
  • swelling of the face, lips, mouth, tongue, or throat
  • itching

What should I tell my healthcare provider before taking REQUIP?

Before you take REQUIP, tell your healthcare provider if you:

  • have daytime sleepiness from a sleep disorder or have unexpected or unpredictable sleepiness or periods of sleep.
  • 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.
  • 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. REQUIP may harm your unborn baby. REQUIP should only be used during pregnancy if needed.
  • are breastfeeding or plan to breastfeed. It is not known if REQUIP passes into your breast milk, and the amount of breast milk you produce may be decreased while taking REQUIP. You and your healthcare provider should decide if you should take REQUIP while breastfeeding.
  • have any other medical conditions.

How should I take REQUIP for RLS?

  • Take REQUIP exactly as directed by your healthcare provider.
  • The usual way to take REQUIP is once in the evening, 1 to 3 hours before bedtime.
  • 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 before you stop taking REQUIP for any reason. Do not restart without consulting your healthcare provider.
  • You can take REQUIP with or without food.

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 if you have any side effect that bothers you or does not go away.

This is not a complete list of side effects and should not take the place of talking with your healthcare provider. Your healthcare provider or pharmacist can give you a more complete list of possible side effects.

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 to 77°F (20°C to 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 take REQUIP for a condition for which it was not prescribed. Do not give REQUIP to other people, even if they have the same symptoms you have. It may harm them.

This side of the patient information leaflet summarizes the most important information about REQUIP for Restless Legs Syndrome (RLS). If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about REQUIP that is written for healthcare professionals. For more information go to www.gsk.com or call 1-888-825-5249 (toll-free).

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.

This Patient Information has been approved by the U.S. Food and Drug Administration.

REQUIP and REQUIP XL are registered trademarks of the GSK group of companies.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2016 the GSK group of companies. All rights reserved.

September 2016

REP:4PIL

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