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Pramipexole extended-release tablets

Pronunciation

Generic Name: pramipexole (PRAM-i-PEX-ole)
Brand Name: Mirapex ER

Pramipexole extended-release tablets is used for:

Treating the signs and symptoms of Parkinson disease. It may also be used for other conditions as determined by your doctor.

Pramipexole extended-release tablets is a dopamine agonist. Exactly how pramipexole extended-release tablets works is unknown. It may increase the action of certain chemical receptors in the brain.

Do NOT use pramipexole extended-release tablets if:

  • you are allergic to any ingredient in pramipexole extended-release tablets
  • you have severe kidney problems or are on dialysis
  • you are taking another medicine that has pramipexole in it

Contact your doctor or health care provider right away if any of these apply to you.

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Before using pramipexole extended-release tablets:

Some medical conditions may interact with pramipexole extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have kidney problems, low blood pressure, dizziness or fainting when you sit or stand up, or sleep problems (eg, daytime sleepiness)
  • if you drink alcohol or have a history of compulsive behavior (eg, eating, gambling, shopping)
  • if you have trouble controlling your muscles

Some MEDICINES MAY INTERACT with pramipexole extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Cimetidine because it may increase the risk of pramipexole extended-release tablets's side effects
  • Butyrophenones (eg, haloperidol), metoclopramide, phenothiazines (eg, chlorpromazine), or thioxanthenes (eg, thiothixene) because they may decrease pramipexole extended-release tablets's effectiveness
  • Levodopa because the risk of its side effects may be increased by pramipexole extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if pramipexole extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use pramipexole extended-release tablets:

Use pramipexole extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with pramipexole extended-release tablets. Talk to your pharmacist if you have questions about this information.
  • Take pramipexole extended-release tablets by mouth with or without food. If nausea occurs, take with food to reduce nausea.
  • Swallow pramipexole extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • Your dose will be started low and gradually increased to achieve the best results. Do not change your dose sooner than recommended.
  • Do not suddenly stop taking pramipexole extended-release tablets without checking with your doctor. Severe side effects, including fever, confusion, and stiff muscles, may occur. If you need to stop pramipexole extended-release tablets, your doctor will gradually lower your dose.
  • If you miss a dose of pramipexole extended-release tablets, take it as soon as possible. If it has been 12 hours or more since the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss several doses, contact your doctor before you start to take pramipexole extended-release tablets again.

Ask your health care provider any questions you may have about how to use pramipexole extended-release tablets.

Important safety information:

  • Pramipexole extended-release tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use pramipexole extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using pramipexole extended-release tablets.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using pramipexole extended-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Pramipexole extended-release tablets may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Some patients who take pramipexole extended-release tablets have reported suddenly falling asleep while performing daily activities (eg, driving, eating, talking). Some patients did not experience drowsiness and felt that they were alert immediately before suddenly falling asleep. Some of these events have been reported as late as 1 year after pramipexole extended-release tablets was started. Use caution when driving, operating machinery, or performing other activities that could be dangerous. Inform your doctor if you experience unusual drowsiness or sleepiness while taking pramipexole extended-release tablets.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using pramipexole extended-release tablets. Tell your doctor right away if you notice such effects.
  • Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if pramipexole extended-release tablets also increases the risk of melanoma. You may need to have skin exams while you are using pramipexole extended-release tablets. Discuss any questions or concerns with your doctor.
  • Tell your doctor or dentist that you take pramipexole extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including blood pressure or skin checks, may be performed while you use pramipexole extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use pramipexole extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially hallucinations.
  • Pramipexole extended-release tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using pramipexole extended-release tablets while you are pregnant. It is not known if pramipexole extended-release tablets is found in breast milk. Do not breast-feed while taking pramipexole extended-release tablets.

Possible side effects of pramipexole extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; headache; loss of appetite; muscle spasms; nausea; tiredness; trouble sleeping; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; balance problems; change in behavior, mood, or emotions; change in the amount of urine produced; chest pain; confusion; dark urine; decreased sexual ability; difficulty walking; fainting; hallucinations; memory problems; muscle pain, tenderness, or weakness; new or unusual skin growths or change in the appearance of a mole; severe or persistent dizziness, drowsiness, or sleepiness; shortness of breath; sudden irresistible urge to sleep or suddenly falling asleep at unusual times; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet; trouble swallowing; unusual or intense urges (eg, gambling, sexual urges); unusual twitching or muscle movements; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of pramipexole extended-release tablets:

Store pramipexole extended-release tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep pramipexole extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about pramipexole extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Pramipexole extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take pramipexole extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pramipexole extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pramipexole extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using pramipexole extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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