Mirapex ER (pramipexole dihydrochloride)

(pra mi pex' ole)

Pramipexole is used alone or with other medications to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance), including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Pramipexole is also used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Pramipexole is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance in the brain that is needed to control movement.

Pramipexole comes as a tablet to take by mouth. When pramiprexole is used to treat Parkinson's disease, it is usually taken three times a day. When pramiprexole is used to treat restless legs syndrome, it is usually taken once a day, 2 to 3 hours before bedtime. Pramipexole may be taken with or without food, but taking pramipexole with food may help to prevent nausea that may be caused by the medication. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take pramipexole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor will start you on a low dose of pramipexole and gradually increase your dose. Your doctor will probably not increase your dose more often than once every 4 to 7 days. It may take several weeks before you reach a dose that works for you. If you are taking pramipexole to treat restless legs syndrome, you should know that as your treatment continues, your symptoms may worsen, may begin earlier in the evening or afternoon, or may occur in the early morning. Call your doctor if your symptoms worsen or if they begin to occur at different times than in the past. Pramipexole controls the symptoms of Parkinson's disease and restless legs syndrome but does not cure these conditions. Continue to take pramipexole even if you feel well. Do not stop taking pramipexole without talking to your doctor. If you are taking pramipexole to treat Parkinson's disease and you suddenly stop taking the medication, you may experience, fever, muscle stiffness, changes in consciousness, and other symptoms. Your doctor will probably decrease your dose gradually over 7 days. If you stop taking pramipexole for any reason, do not start to take the medication again without talking to your doctor. Your doctor will probably want to increase your dose again gradually.

Before taking pramipexole,
• tell your doctor and pharmacist if you are allergic to pramipexole or any other medications, or any of the ingredients in pramipexole tablets. Ask your doctor or pharmacist for a list of the inactive ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: amantadine (Symadine, Symmetrel); antidepressants; antihistamines; ; cimetidine (Tagamet); diltiazem (Cardiazem, Dilacor XR); ; levodopa (Larodopa, Dopar, in Sinemet); medications for allergies, anxiety, mental illness, nausea, and seizures; metoclopramide (Reglan); quinidine; quinine; ranitidine (Zantac, Zantac 75); sedatives; sleeping pills; ; tranquilizers; triamterene (Dyrenium, in Dyazide, in Maxzide); and verapamil (Isoptin, Calan, Verelan, and others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had an urge to gamble that was difficult to control, trouble controlling movement of your muscles,a sleep disorder other than restless legs syndrome, dizziness, fainting, low blood pressure, or heart or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking pramipexole, call your doctor. Do not breast-feed while you are taking pramipexole.
• if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking pramipexole.
• you should know that pramipexole may make you drowsy or may cause you to suddenly fall asleep during your regular daily activities. You might not feel drowsy before you suddenly fall asleep. Do not drive a car or operate machinery at the beginning of your treatment until you know how pramipexole will affect you. If you suddenly fall asleep while you are doing something such as watching television or riding in a car, or if you become very drowsy, call your doctor. Do not drive or operate machinery until you talk to your doctor.
• remember that alcohol can add to the drowsiness caused by this medication. Tell your doctor if you regularly drink alcoholic beverages.
• you should know that pramipexole may cause dizziness, lightheadedness, nausea, fainting, or sweating when you get up too quickly from a sitting or lying position. This is more common when you first start taking pramipexole, or when your dose is increased. To avoid this problem, get out of the chair or bed slowly, resting your feet on the floor for a few minutes before standing up.

Unless your doctor tells you otherwise, continue your normal diet.

If you are taking pramipexole to treat Parkinson's disease, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are taking pramipexole to treat restless legs syndrome, skip the missed dose. Take your regular dose 2 to 3 hours before your next bedtime. Do not double the next dose to make up for the missed dose.

Pramipexole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• abnormal body movements and motions
• weakness
• dizziness
• drowsiness
• difficulty falling asleep or staying asleep
• difficulty remembering or thinking
• confusion
• abnormal thoughts or dreams
• heartburn
• constipation
• diarrhea
• loss of appetite
• weight loss
• dry mouth
• joint pain
• frequent urination or urgent need to urinate
• difficulty urinating or pain when urinating
• decreased sexual interest or ability
• swelling of the arms, hands, feet, ankles, or lower legs

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• hallucinations (seeing things or hearing voices that do not exist)
• changes in vision
• chest pain
• shortness of breath
• dark, red, or cola-colored urine
• muscle tenderness
• muscle stiffness or aching
• muscle weakness

Some people who took medications such as pramipexole to treat Parkinson's disease or restless legs syndrome developed gambling problems, an increased interest in sex, or overeating problems. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you have difficulty controlling any of these behaviors. Tell your family members about these risks so that they can call the doctor even if you do not realize that your behavior has become a problem. People who have Parkinson's disease may have a greater risk of developing melanoma (a type of skin cancer) than people who do not have Parkinson's disease. There is not enough information to tell whether medications used to treat Parkinson's disease such as pramipexole increase the risk of developing skin cancer. You should have regular skin examinations to check for melanoma while you are taking pramipexole even if you do not have Parkinson's disease. Talk to your doctor about the risk of taking pramipexole. Pramipexole may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.