Pramipexole, Oral

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KEY POINTS

• This medicine is taken by mouth to treat the symptoms of Parkinson's disease or restless legs syndrome. Take it exactly as directed.
• This medicine may cause you to suddenly fall asleep without warning, have unusual urges, or cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: nonergot dopamine agonist; anti-Parkinson's

Generic and brand names: pramipexole, oral; Mirapex; Mirapex ER

What is this medicine used for?

This medicine is taken by mouth to treat the symptoms of Parkinson's disease. It is also used to treat restless legs syndrome (RLS).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A sleep disorder
• Heart failure
• Kidney disease
• Low blood pressure
• Mental health problems such as schizophrenia or hallucinations

Females of childbearing age: Talk with your healthcare provider if you are pregnant or become pregnant while taking this medicine. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes along with any other medicine prescribe to treat your condition. Your healthcare provider may gradually increase your dosage to find the amount that is best for you. Follow your healthcare provider's directions carefully.

Check with your healthcare provider before using this medicine in children under age 18.

Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

If you are taking extended-release tablets, do not break, crush, or chew them. Swallow them whole.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may cause hallucinations (seeing or hearing things that are not there). Older adults are more at risk for this reaction.

You may become dizzy or nauseated, feel faint, or start to sweat when you get up quickly from a sitting or lying position. Getting up slowly may help. This may happen more often when you first start taking this medicine.

This medicine may cause you to fall asleep suddenly without warning during daily activities, including driving a car, eating, or talking. This may happen even after you have been taking the medicine for several months. Contact your healthcare provider if the drowsiness continues or becomes severe.

This medicine increases the effects of alcohol and other medicines that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

Some people taking medicines for Parkinson's disease have developed skin cancer (melanoma). Talk to your healthcare provider about this and what to watch for. You may need to have regular skin exams.

You may have increased sexual urges, unusual urges to gamble or shop, or other intense urges while taking this medicine. Talk with your healthcare provider if you have any intense or unusual urges while taking this medicine.

Contact your healthcare provider if your condition does not improve or if it gets worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fainting spells or blackouts; constant drowsiness or dizziness; hallucinations; fever; muscle stiffness; confusion; memory problems; unusual muscle spasms of the face, mouth, or neck; problems with balance or walking; swelling of arms, feet, hands, or legs; fast or irregular heartbeat; chest pain; trouble breathing; unusual muscle pain or tenderness; red or dark-colored urine; trouble urinating or change in how much you urinate; new or increased gambling urges, increased sexual urges, or other intense urges; vision changes.

Other: Weakness, dry mouth, abnormal dreams, trouble sleeping, nausea, mild dizziness, vomiting, headache, tiredness, constipation, loss of appetite.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, thiothixene (Navane), trifluoperazine and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), and topiramate (Qudexy, Topamax, Trokendi)
• Heart medicines such as diltiazem (Cardizem, Cartia, Tiazac), quinidine, and verapamil (Calan, Covera, Verelan)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and ranitidine (Zantac)
• Metoclopramide (Metozolv, Reglan)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, SAMe, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Other Parkinson’s disease medicines such as amantadine (Symmetrel) and levodopa/carbidopa (Duopa, Rytary, Sinemet)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Quinine
• Sleeping pills such as eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Edluar, Intermezzo)
• Triamterene/hydrochlorothiazide (Dyazide, Maxzide) and triamterene (Dyrenium)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.