PATIENT INFORMATION Ropinirole Hydrochloride Tablets If you have Restless Legs Syndrome (RLS, also known as Ekbom Syndrome), read the following Read this information completely before you start taking ropinirole hydrochloride tablets. Read the information each time you get more medicine. There may be new information. This leaflet provides a summary about ropinirole hydrochloride tablets. 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 ropinirole hydrochloride tablets. What is ropinirole hydrochloride tablets? Ropinirole hydrochloride tablets 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 ropinirole hydrochloride? • Patients with RLS should take ropinirole hydrochloride tablets differently than patients with Parkinson's disease
(see How should I take ropinirole hydrochloride tablets for RLS? for the recommended dosing for RLS). A lower dose of ropinirole hydrochloride is generally needed for patients with RLS, and is taken once daily before bedtime.
• There are known side effects of ropinirole hydrochloride. 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 ropinirole hydrochloride tablets?).
• Before starting ropinirole hydrochloride tablets, be sure to tell your doctor if you are taking any medicines that
Unusual urges: Some patients taking ropinirole hydrochloride tablets 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 ropinirole hydrochloride tablets? You should not take ropinirole hydrochloride tablets 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 ropinirole hydrochloride tablets.
• 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 ropinirole hydrochloride tablets.
• you start or stop taking other medicines while you are taking ropinirole hydrochloride tablets. This may increase
• you start or stop smoking while you are taking ropinirole hydrochloride tablets. Smoking may decrease the
treatment effect of ropinirole hydrochloride tablets.
• 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
How should I take ropinirole hydrochloride tablets for RLS? • Be sure to take ropinirole hydrochloride tablets exactly as directed by your doctor or healthcare provider. • The usual way to take ropinirole hydrochloride tablets is once in the evening, 1 to 3 hours before bedtime.
• Your doctor will start you on a low dose of ropinirole hydrochloride tablets. 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
• Contact your doctor, if you stop taking ropinirole hydrochloride tablets for any reason. Do not restart without
• You can take ropinirole hydrochloride tablets with or without food. Taking ropinirole hydrochloride tablets with
food may decrease the chances of feeling nauseated.
What are the possible side effects of ropinirole hydrochloride tablets? • Most people who take ropinirole hydrochloride tablets tolerate it well. The most commonly reported side effects
in people taking ropinirole hydrochloride tablets for RLS are nausea, vomiting, dizziness, and drowsiness or sleepiness. You should be careful until you know if ropinirole hydrochloride tablets 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 ropinirole hydrochloride tablets. Your chances of falling asleep while doing normal activities while taking ropinirole hydrochloride tablets are greater if you are taking other medicines that cause drowsiness.
• When you start taking ropinirole hydrochloride tablets 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 ropinirole
hydrochloride tablets. These were uncommon in patients taking ropinirole hydrochloride tablets for RLS. The risk is greater in patients with Parkinson's disease who are elderly, taking ropinirole hydrochloride tablets with L-dopa, or taking higher doses of ropinirole hydrochloride tablets than recommended for RLS.
Some patients taking ropinirole hydrochloride tablets 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 dotor. 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Other Information about ropinirole hydrochloride tablets • 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. Ropinirole hydrochloride is one of the medicines used to treat Parkinson’s disease, therefore, patients being treated with ropinirole hydrochloride tablets should have periodic skin examinations.
• Take ropinirole hydrochloride tablets exactly as your doctor prescribes it. • Do not share ropinirole hydrochloride tablets with other people, even if they have the same symptoms you have. • Keep ropinirole hydrochloride tablets out of the reach of children. • Store ropinirole hydrochloride tablets at room temperature out of direct sunlight.
• Keep ropinirole hydrochloride tablets in a tightly closed container. This leaflet summarizes important information about ropinirole hydrochloride tablets. Medicines are sometimes prescribed for purposes other than those listed in this leaflet. Do not take ropinirole hydrochloride tablets for a condition for which it was not prescribed. For more information, talk with your doctor or pharmacist. They can give you information about ropinirole hydrochloride tablets that is written for healthcare professionals.
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