MIRAPEX 1.5 MG TABLET

USES: Pramipexole 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"). This medication is also used to treat a certain medical condition (restless legs syndrome - RLS) that causes an unusual urge to move the legs. Symptoms usually occur at night along with uncomfortable/unpleasant feelings in the legs. This medication can decrease these symptoms and thereby improve sleep. Pramipexole is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

Indications : idiopathic parkinsonism, restless leg syndrome, fibromyalgia

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used for a certain painful condition (fibromyalgia).

SIDE EFFECTS: Nausea, dizziness, drowsiness, lightheadedness, trouble sleeping, constipation, headache, or dry mouth may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. 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. Tell your doctor right away if you have any serious side effects, including: fainting, mental/mood changes (such as confusion, agitation, hallucinations), unusual strong urges (such as increased gambling, increased sexual urges), increased difficulty moving/walking, muscle cramps/spasm, unusual posture changes (such as the neck or body bending forward), restlessness, decreased sexual ability, increased shakiness (tremor)/stiffness, swelling of the ankles/feet. Get medical help right away if you have any very serious side effects, including: chest pain, fever, unusually fast/slow/irregular heartbeat, muscle pain/weakness, unusual tiredness, signs of kidney problems (such as change in the amount of urine), vision changes. Some people taking pramipexole 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 pramipexole 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 pramipexole and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with or without food, as directed by your doctor. Taking this medication with food may lessen 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. The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or take it more often than directed. 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 pramipexole for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. If you temporarily stop taking this medication, you may need to start this medication again at a low dose and gradually increase your dose. Talk with your doctor about how to restart this medication. It may take a few weeks for the effects of this medication to be noticed. Tell your doctor if your condition does not get better or if it gets worse.

PRECAUTIONS: Before taking pramipexole, 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: low blood pressure, heart problems (e.g., irregular heartbeat, heart failure), kidney problems, mental/mood disorders (e.g., confusion, hallucinations, psychosis, schizophrenia), 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. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be at a greater risk for dizziness and hallucinations while using this drug. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This drug may pass into breast milk and could have undesirable effects on a nursing infant. It may also affect milk production. Breast-feeding is not recommended while using this drug. 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 include: antipsychotics (such as chlorpromazine, haloperidol, thiothixene), cimetidine, metoclopramide. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone). 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.

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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