Requip (Ropinirole Hcl) Drug Information: Medication Guide and Patient Information

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May 27, 2012

Requip

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Parkinson's disease is the second most common neurodegenerative disorder and the most common movement disorder. It is characterized by progressive loss of muscle control, which leads to trembling of the limbs and head while at rest, stiffness, slowness, and impaired balance. As symptoms worsen, it may become difficult to walk, talk, and complete simple tasks.

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In the United States, about 1 million people are affected by Parkinson's disease and worldwide about 5 million. Most individuals who develop Parkinson's disease are 60 years of age or older. Parkinson's disease occurs in approximately 1% of i...

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Requip

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PATIENT INFORMATION

REQUIP®
(ropinirole) tablets

If you have Restless Legs Syndrome (RLS, also known as Ekbom Syndrome), read this portion.

Read this information completely before you start taking REQUIP (ropinirole hcl) . Read the information each time you get more medicine. There may be new information. This leaflet provides a summary about REQUIP (ropinirole hcl) . 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 (ropinirole hcl) .

What is REQUIP (ropinirole hcl) ?

REQUIP (ropinirole hcl) 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 (ropinirole hcl) ?

Patients with RLS should take REQUIP (ropinirole hcl) differently than patients with Parkinson's disease (see How should I take REQUIP (ropinirole hcl) for RLS? for the recommended dosing for RLS). A lower dose of REQUIP (ropinirole hcl) is generally needed for patients with RLS, and is taken once daily before bedtime.
There are known side effects of REQUIP (ropinirole hcl) . 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 (ropinirole hcl) ?).
Before starting REQUIP (ropinirole hcl) , be sure to tell your doctor if you are taking any medicines that make you drowsy.

Unusual urges: Some patients taking REQUIP (ropinirole hcl) or REQUIP (ropinirole hcl) XL get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider.

Who should not take REQUIP (ropinirole hcl) ?

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 breastfeeding.
you have daytime sleepiness from a sleep disorder other than RLS or have unexpected sleepiness or periods of sleep while taking REQUIP (ropinirole hcl) .
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 (ropinirole hcl) .
you start or stop taking other medicines while you are taking REQUIP (ropinirole hcl) . This may increase your chances of getting side effects.
you start or stop smoking while you are taking REQUIP (ropinirole hcl) . Smoking may decrease the treatment effect of REQUIP (ropinirole hcl) .
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 (ropinirole hcl) .

How should I take REQUIP (ropinirole hcl) for RLS?

Be sure to take REQUIP (ropinirole hcl) exactly as directed by your doctor or healthcare provider.
The usual way to take REQUIP (ropinirole hcl) is once in the evening, 1 to 3 hours before bedtime.
Your doctor will start you on a low dose of REQUIP (ropinirole hcl) . Your doctor may change the dose until you are taking the amount of medicine that is right for you 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 doctor, if you stop taking REQUIP (ropinirole hcl) for any reason. Do not restart without consulting your doctor.
You can take REQUIP (ropinirole hcl) with or without food. Taking REQUIP (ropinirole hcl) with food may decrease the chances of feeling nauseated.

What are the possible side effects of REQUIP (ropinirole hcl) ?

Most people who take REQUIP (ropinirole hcl) tolerate it well. The most commonly reported side effects in people taking REQUIP (ropinirole hcl) for RLS are nausea, vomiting, dizziness, and drowsiness or sleepiness. You should be careful until you know if REQUIP (ropinirole hcl) 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 (ropinirole hcl) . Your chances of falling asleep while doing normal activities while taking REQUIP (ropinirole hcl) are greater if you are taking other medicines that cause drowsiness.
When you start taking REQUIP (ropinirole hcl) 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.
Hallucinations (unreal sounds, visions, or sensations) have been reported in patients taking REQUIP (ropinirole hcl) . These were uncommon in patients taking REQUIP (ropinirole hcl) for RLS. The risk is greater in patients with Parkinson's disease who are elderly, taking REQUIP (ropinirole hcl) with L-dopa, or taking higher doses of REQUIP (ropinirole hcl) than recommended for RLS.

Some patients taking REQUIP (ropinirole hcl) get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider.

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.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other Information about REQUIP (ropinirole hcl)

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 (ropinirole hcl) is one of the medicines used to treat Parkinson's disease, therefore, patients being treated with REQUIP (ropinirole hcl) should have periodic skin examinations.
Take REQUIP (ropinirole hcl) exactly as your doctor prescribes it.
Do not share REQUIP (ropinirole hcl) with other people, even if they have the same symptoms you have.
Keep REQUIP (ropinirole hcl) out of the reach of children.
Store REQUIP (ropinirole hcl) at room temperature out of direct sunlight.
Keep REQUIP (ropinirole hcl) in a tightly closed container.

This leaflet summarizes important information about REQUIP (ropinirole hcl) . Medicines are sometimes prescribed for purposes other than those listed in this leaflet. Do not take REQUIP (ropinirole hcl) 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 (ropinirole hcl) that is written for healthcare professionals.

PATIENT INFORMATION