"Sept. 19, 2012 -- The FDA is investigating a possible risk of heart failure linked to Mirapex, a drug used to treat Parkinson's disease and restless legs syndrome.
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- Patient Information:
Details with Side Effects
(pramipexole dihydrochloride) Extended ReleaseTablets
Read the Patient Information that comes with MIRAPEX ER tablets before you start taking it and each time you refill your prescription. The information may have changed. This leaflet does not take the place of discussions with your doctor about your medical condition or your treatment.
What is MIRAPEX ER?
MIRAPEX ER tablets are a prescription medicine to treat the signs and symptoms of Parkinson's disease.
MIRAPEX ER tablets have not been studied in children. It is not known if MIRAPEX ER tablets are safe or effective in children.
Please speak to your doctor for more information about why MIRAPEX ER tablets were prescribed for you.
Who should not take MIRAPEX ER?
You should not take MIRAPEX ER tablets if you are allergic (hypersensitive) to the active ingredient (pramipexole) or any of the other ingredients listed at the end of this leaflet.
What should I tell my doctor before taking MIRAPEX ER?
- Before taking MIRAPEX ER, tell your doctor about all
of your medical conditions, including if you
- feel sleepy during the day, if you use any medications that make you sleepy, or are taking any medication which your doctor informs you may increase the effects of MIRAPEX ER, such as cimetidine.
- have low blood pressure, or if you feel dizzy or faint, especially when getting up from a lying or sitting position.
- have trouble controlling your muscles (dyskinesia).
- have kidney problems.
- are pregnant or plan to become pregnant. Based on animal data, MIRAPEX ER may harm your unborn baby.
- are breastfeeding. It is not known if MIRAPEX ER tablets will pass into your breast milk. You and your doctor should decide if you will take MIRAPEX ER tablets or breast-feed. You should not do both.
- drink alcohol. Alcohol can increase the chance that MIRAPEX ER tablets will make you feel sleepy or fall asleep when you should be awake.
- Tell your doctor about all the medicines you take,
- any prescription and non-prescription medicines. Especially tell your doctor if you take any other medicines that make you sleepy.
- any non-prescription medicines, including vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new prescription. MIRAPEX ER tablets and other medicines may interact with each other causing side effects. MIRAPEX ER tablets may affect the way other medicines work, and other medicines may affect how MIRAPEX ER tablets work.
How should I take MIRAPEX ER?
- Follow your doctor's directions carefully. MIRAPEX ER is taken once daily. Your doctor will tell you how to use MIRAPEX ER tablets.
- Your doctor may change your dose until you are taking the right amount of medicine to help control your symptoms. Do not take more or less MIRAPEX ER tablets than your doctor tells you to.
- Swallow tablets whole. Do not chew, crush, or divide MIRAPEX ER tablets.
- MIRAPEX ER tablets can be taken with or without food. Taking MIRAPEX ER tablets with food may lower your chances of getting nausea.
- If you miss a dose, do not double your next dose. Skip the dose you missed and take your next regular dose.
- If you have Parkinson's disease and are stopping MIRAPEX ER tablets, you should stop MIRAPEX ER tablets slowly over 7 days. Do not suddenly stop taking MIRAPEX ER tablets without talking to your healthcare provider. If you stop this medicine suddenly, you may develop fever, confusion, or severe muscle stiffness. Be sure to tell your doctor right away if you stop taking MIRAPEX ER tablets for any reason. Do not start taking MIRAPEX ER tablets again before speaking with your doctor.
What important safety information should I know about MIRAPEX ER?
Please read this document carefully; many sections contain safety information.
This medicine was prescribed for you by your doctor for your condition. Do not use it for another condition or give the medicine to others.
Pramipexole is the active ingredient that is in both MIRAPEX ER tablets and immediate-release pramipexole tablets. Be sure that you do not take both immediate-release pramipexole (MIRAPEX) and MIRAPEX ER.
- Falling asleep during normal activities.
MIRAPEX ER tablets may cause you to fall asleep while you are doing daily
activities such as driving, talking with other people, or eating.
Some people taking the medicine in MIRAPEX ER tablets have had car accidents because they fell asleep while driving.
Some patients did not feel sleepy before they fell asleep while driving. You could fall asleep without any warning.
Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how MIRAPEX ER tablets affect you. Sleepiness caused by MIRAPEX ER may first occur as late as one year after initiation of treatment.
Tell your doctor right away if you fall asleep while you are doing activities such as talking with people, eating, or driving, or if you feel sleepier than is normal for you.
- Hallucinations. Hallucinations (unreal visions, sounds, or sensations) can occur in patients taking MIRAPEX ER tablets. The chances of having hallucinations are higher in patients with Parkinson's disease who are elderly (defined in this case as age 65 or older). If you have hallucinations, talk with your healthcare provider.
- Unusual urges. Some patients taking certain medicines to treat Parkinson's disease, including MIRAPEX ER tablets, have reported problems, such as gambling, compulsive eating, compulsive buying, and increased sex drive. If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.
- Melanoma. Studies of people with Parkinson's disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson's disease. It is not known if this problem is associated with Parkinson's disease or the medicines used to treat Parkinson's disease. MIRAPEX ER tablets are one of the medicines used to treat Parkinson's disease; therefore, patients being treated with MIRAPEX ER tablets should have periodic skin examinations.
What are the possible side effects of MIRAPEX ER?
MIRAPEX ER tablets can cause serious side effects, including:
- falling asleep during normal daily activities. See “What important safety information should I know about MIRAPEX ER?”
- low blood pressure when you sit or stand up quickly. You may have dizziness, nausea, fainting, or sweating. Sit and stand up slowly after you have been sitting or lying down for a while.
- hallucinations. You may see, hear, feel, or taste something that isn't there. You have a higher chance of having hallucinations if you are over 65 years old.
- unusual urges. See “What important safety information should I know about MIRAPEX ER?”
The most common side effects in people taking MIRAPEX ER tablets for early Parkinson's disease are sleepiness, nausea and vomiting, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and edema (swelling of the feet and ankles).
These are not all the possible side effects of MIRAPEX ER tablets. Tell your doctor if you have any side effect that bothers you.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088, or by visiting www.fda.gov/medwatch.
What should I avoid while taking MIRAPEX ER?
- Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how MIRAPEX ER affects you. Sleepiness caused by MIRAPEX ER may first occur as late as one year after initiation of treatment. See “What important safety information should I know about MIRAPEX ER?”
- Do not drink alcohol while taking MIRAPEX ER tablets. It can increase your chances of feeling sleepy or falling asleep when you should be awake.
How should I store MIRAPEX ER?
- Store MIRAPEX ER tablets at room temperature [77°F (25°C)]. Short-term exposure to higher or lower temperatures [from 59°F (15°C) to 86°F (30°C)] is acceptable. Ask your doctor or pharmacist if you have any questions about storing your tablets.
- Protect from exposure to high humidity.
- Keep MIRAPEX ER tablets and all medicines out of the reach of children.
What does MIRAPEX ER look like?
These pictures show what MIRAPEX ER tablets look like. Notice that each strength tablet looks different. Immediately call your pharmacist if you receive a MIRAPEX ER tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.
Other Information about MIRAPEX ER
This Patient Information leaflet summarizes the most important information about MIRAPEX ER tablets. If you would like more information, talk with your doctor or pharmacist. You can ask your doctor or pharmacist for more information about MIRAPEX ER tablets that is written for healthcare professionals. For more information, call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800542-6257 or (TTY) 1-800-459-9906.
What are the ingredients in MIRAPEX ER?
Active Ingredient: pramipexole dihydrochloride monohydrate.
Inactive Ingredients: hypromellose, corn starch, carbomer homopolymer, colloidal silicon dioxide, and magnesium stearate.
Last reviewed on RxList: 3/26/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Mirapex ER Information
Mirapex ER - User Reviews
Mirapex ER User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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