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Requip XL 2mg Tablets
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Product ID: **REQUIPXL2
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Product Summary

PRESCRIPTION REQUIRED


IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ROPINIROLE EXTENDED-RELEASE - ORAL

(row-PIN-uh-roll)

COMMON BRAND NAME(S): Requip XL

USES: This medication is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move ("on-off syndrome"). Ropinirole works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking ropinirole and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth, usually once daily with or without food, or as directed by your doctor. Taking this medication with food may decrease the risk of nausea. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. The dosage is based on your medical condition and response to treatment. Your doctor may direct you to start this medication at a low dose and gradually increase your dose to reduce the risk of side effects. Follow your doctor's instructions carefully. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. If you stop taking this medication for several days, you may need to slowly increase your dose back to your previous dosage. Talk with your doctor about how to restart this medication. Do not stop taking this medication without consulting your doctor. If you suddenly stop taking this drug, withdrawal symptoms such as fever, muscle stiffness, and confusion may occur. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Nausea, drowsiness, dizziness, abdominal pain/discomfort, or headache may occur. If these effects persist or worsen, tell your doctor promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. You may develop a sudden drop in blood pressure, which can cause dizziness, nausea, and fainting. This is more likely when you are first starting the medication, when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position. Tell your doctor immediately if any of these unlikely but serious side effects occur: new or worsening uncontrolled movements (dyskinesia), mental/mood changes (such as hallucinations), unusual urges (such as increased gambling or sexual urges). A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ropinirole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, low blood pressure, sleep disorder (such as sleep apnea, narcolepsy), mental/mood disorder, liver problems. Some people taking ropinirole have reported falling asleep suddenly during usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without feelings of drowsiness beforehand. This effect may occur at any time during treatment, including up to 1 year after starting this medication. Therefore, do not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. This risk is increased with the use of alcohol or other medications that can make you drowsy (see Drug Interactions section). Consult your doctor for more details. Older adults may be more sensitive to the side effects of this drug, especially mental/mood changes (such as hallucinations). This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antipsychotic medications (such as chlorpromazine, haloperidol, thiothixene), metoclopramide. Other medications can affect the removal of ropinirole from your body, which may affect how ropinirole works. Examples include cimetidine, fluvoxamine, mexiletine, omeprazole, rifampin, drugs to treat seizures (such as carbamazepine, phenobarbital), among others. Tell your doctor or pharmacist if you are taking other products that can cause drowsiness, including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). If you are taking this drug to treat Parkinson's disease, tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from moisture and light. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2012. Copyright(c) 2012 First Databank, Inc.

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