ROPINIROLE HCL 0.5 MG TABLET

USES: This medication is used alone or with other medications to treat Parkinson's d...

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 is also used to treat restless legs syndrome (RLS). It may improve your sleep by decreasing the urge to move your legs and decreasing uncomfortable/unpleasant feelings in the legs. This medication works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

Indications : idiopathic parkinsonism, restless leg syndrome

SIDE EFFECTS: Nausea, vomiting, constipation, dizziness, drowsiness, weakness, unusual sweating, headache, and dry mouth may occur. If these effects persist or worsen, notify your doctor promptly. Remember that this medication has been prescribed because your doctor 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 also 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 or when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position. This medication may also raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: difficulty moving or walking, mental/mood changes (such as confusion, agitation, hallucinations), muscle cramps/spasms, decreased sexual ability, unusual strong urges (such as increased gambling, increased sexual urges), swelling of the ankles/feet, chest pain, unusually fast/slow/irregular heartbeat, vision changes. Some people taking ropinirole have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with ropinirole even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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 regarding the information, consult your doctor or pharmacist. If you are taking this medication for Parkinson's disease, take this medication by mouth with or without food as directed by your doctor, usually 3 times a day. Taking this medication with food may reduce nausea. To reduce your risk of side effects (such as drowsiness, low blood pressure), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. If you are using this medication for RLS, take this medication by mouth, usually once daily with or without food as directed by your doctor, usually 1 to 3 hours before bedtime. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Take this medication as prescribed. Do not increase your dose or take it more often than directed. If you stop taking this medication for several days, you may need to increase your dose slowly back to your previous dosage. Talk with your doctor about how to restart the medication. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this medication is suddenly stopped. Also, if you suddenly stop using this medication, you may have withdrawal symptoms (such as anxiety, depression, confusion, fever, muscle stiffness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used ropinirole for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. If you are taking this medication for RLS, tell your doctor if your symptoms increase or get worse in the early morning, or if you start getting symptoms earlier in the evening or late afternoon. Your doctor may need to change your treatment. The dosage is based on your medical condition and response to treatment. It may take a few weeks for this medication to take effect. Tell your doctor if your condition does not get better or if it gets worse.

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 problems (including irregular heartbeat), mental/mood disorders (e.g., confusion, hallucinations, psychoses, schizophrenia), difficulty walking, kidney problems, liver problems, high or low blood pressure, sleep disorder (e.g., sleep apnea, narcolepsy). This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section. Older adults may be more sensitive to the side effects of this drug, especially mental/mood changes (such as hallucinations), nausea, and vomiting. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: antipsychotics (e.g., 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, among others. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). 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 the level of this medication in your bloodstream. Tell your doctor if you smoke or if you have recently stopped smoking.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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