Mirapex ER Oral

See also How to Use section.
Nausea, vomiting, dizziness, drowsiness, trouble sleeping, constipation, headache, cough, or dry mouth 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.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, depression, hallucinations), muscle cramps/spasm.
Tell your doctor immediately if any of these rare but very serious side effects occur: swelling of the ankles/feet, chest pain, trouble breathing, compulsive behaviors (such as pathological gambling), muscle pain/weakness, unusual tiredness, change in amount of urine, vision changes.
Some people taking pramipexole have reported falling 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 any time during treatment with pramipexole, including up to 1 year after starting the medication. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. 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 is increased with use of alcohol or other medications that can make you drowsy. You may also develop a sudden drop in blood pressure, which can cause dizziness, nausea, sweating, 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.
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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Side Effects section.
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).
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for side effects such as 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. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

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.
If you are taking levodopa or a carbidopa/levodopa combination, your doctor may direct you to decrease your levodopa dose after you start taking pramipexole.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (such as diphenhydramine), anti-seizure drugs (such as carbamazepine), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (such as codeine), psychiatric medicines (such as risperidone, amitriptyline, trazodone).
Check the labels on all your medicines (such as allergy, cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian 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 unless it is almost time for the next dose. 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 at room temperature away from light and moisture. Keep all medicines 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 2010. Copyright(c) 2010 First Databank, Inc.