Manufacturer: Sun Pharmaceutical Industries Ltd.
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What is this medicine?
PRAMIPEXOLE has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.
Pramipexole tablets are used to treat signs and symptoms of Parkinson's disease and for the treatment of Restless Legs Syndrome (RLS).
What should I tell my health care provider before I take this medicine?
You should not take Pramipexole if your are allergic to pramipexole. Some people taking Pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.
To make sure you can safely take Pramipexole, tell your doctor if you have any of these other conditions:
- low blood pressure;
- kidney disease; or
- tremors (dyskinesia) or uncontrolled muscle movements.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking Pramipexole. It is not known whether the medicine actually causes this effect. Talk with your doctor if you believe you have any intense or unusual urges while taking Pramipexole.
Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.
FDA pregnancy category C. It is not known whether Pramipexole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Pramipexole. It is not known whether pramipexole passes into breast milk or if it could harm a nursing baby. Do not use Pramipexole without telling your doctor if you are breast-feeding a baby.
Pramipexole may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.
How should I take this medicine?
Take Pramipexole exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
The dose and timing of Pramipexole in treating Parkinson's disease is different from the dose and timing in treating Restless Legs Syndrome. Follow the directions on your prescription label.
Pramipexole can be taken with or without food. Take the medication with food if it upsets your stomach. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the tablet may cause too much of the medicine to be released at one time.
If you are taking this medication for Restless Legs Syndrome, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.
Do not stop using Pramipexole without first talking to your doctor. You may need to use less and less before you stop the medication completely.
What if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What may interact with this medicine?
Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Pramipexole. Tell your doctor if you regularly use any of these medicines, or any other medicines for Parkinson's disease.
Tell your doctor about all other medicines you use, especially:
- amantadine (Symmetrel);
- cimetidine (Tagamet);
- diltiazem (Cardizem, Cartia, Dilacor, Tiazac);
- ranitidine (Zantac);
- quinidine (Quin-G);
- triamterene (Dyrenium);
- verapamil (Calan, Covera, Isoptin);
- medicine to prevent or treat nausea and vomiting, such as metoclopramide (Reglan, Metozolv) or promethazine (Pentazine, Phenergan, Anergan, Antinaus); or
- medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), thiothixene (Navane), thioridazine (Mellaril), and others.
This list is not complete and other drugs may interact with Pramipexole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
What should I watch for while taking this medicine?
Pramipexole may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of Pramipexole.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
What side effects may I notice from this medicine?
Get emergency medical help if you have any of these signs of an allergic reaction to Pramipexole: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Pramipexole and call your doctor at once if you have any of these serious side effects:
- extreme drowsiness, falling asleep suddenly, even after feeling alert;
- nausea, sweating, feeling light-headed, fainting;
- muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
- chest pain, cough with white or pink phlegm (mucus), wheezing;
- feeling short of breath (even with mild exertion), swelling, rapid weight gain;
- feeling weak or tired, loss of appetite, rapid weight loss;
- fast or uneven heartbeats; or
- tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.
Less serious Pramipexole side effects may include:
- dry mouth, stomach pain, vomiting, constipation;
- headache, dizziness, spinning sensation;
- mild drowsiness;
- swelling in your hands or feet;
- appetite or weight changes;
- blurred vision;
- sleep problems (insomnia), unusual dreams;
- amnesia, forgetfulness, thinking problems; or
- impotence, loss of interest in sex, or trouble having an orgasm.
Where can I keep my medicine?
Store Pramipexole at room temperature away from moisture, heat, and light.