Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

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.

How to use Mirapex ER

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. 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 times 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 immediately. 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.

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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada.

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.

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 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 May 2014. Copyright(c) 2014 First Databank, Inc.