Pramipexole ER 1.5mg Tablets

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.

PRAMIPEXOLE EXTENDED-RELEASE - ORAL

(PRAM-i-PEX-ole)

COMMON BRAND NAME(S): Mirapex

USES: Pramipexole is used alone or with other medications to treat Parkinson\'s disease. It can improve your ability to move and can 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\"). Pramipexole is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

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 medical condition that causes an unusual urge to move the legs (restless legs syndrome - RLS) or a certain painful condition (fibromyalgia).

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. Swallow this medication whole. Do not crush, chew, or break the tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Taking this medication with food may reduce nausea. To decrease the risk of side effects (such as drowsiness, low blood pressure) when you first start taking pramipexole, your doctor will slowly increase your dosage until the best dose for you is reached. Take this medication as prescribed. The dosage is based on your medical condition and response to treatment. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day. 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 your doctor\'s approval. Although very unlikely, if you suddenly stop taking this drug, a serious reaction may occur including fever, muscle stiffness, and confusion. Report any such reactions to your doctor right away. If your doctor directs you to stop regular treatment with this drug, gradually reducing the dosage as directed will help prevent such reactions. It may take a few weeks for full effects of this medication to be noticed. Tell your doctor if your symptoms do not improve or if they worsen.

SIDE EFFECTS: See also How to Use section. Nausea, vomiting, dizziness, drowsiness, lightheadedness, trouble sleeping, constipation, headache, cough, 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. Tell your doctor if you see a swollen tablet or pieces of a tablet in your stool. 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. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression, hallucinations), unusual strong urges (such as increased gambling, increased sexual urges), muscle cramps/spasm, swelling of the ankles/feet. Get medical help right away if you have any very serious side effects, including: chest pain, trouble breathing, 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.

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 (such as irregular heartbeat, heart failure), kidney problems, mental/mood disorders (such as confusion, hallucinations, psychosis, schizophrenia), sleep disorder (such as sleep apnea, narcolepsy). 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. This drug may make you drowsy or dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. See also Side Effects section. 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. Therefore, 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, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic 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.

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 and it is within 12 hours of the time you usually take the dose, take it as soon as you remember. If it is more than 12 hours from the time you usually take the dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. 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.

Information last revised August 2016. Copyright(c) 2016 First Databank, Inc.