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pramipexole - oral, Mirapex (cont.)

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking pramipexole and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth with or without food, as directed by your doctor. Taking this medication with food may reduce nausea. To decrease the risk of side effects (e.g., drowsiness, low blood pressure) when you first start taking pramipexole, your doctor will slowly increase your dosage until the best dose for you is reached. Take this medication as prescribed. Do not increase your dose or take it more often than directed.Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.If you stop taking this medication for several days, you may need to increase your dose slowly back to your previous dosage. Talk with your doctor about how to restart the medication. Do not stop taking this medication without your doctor's approval. Although very unlikely, if you suddenly stop taking this drug, withdrawal reactions may occur. Such reactions can include fever, muscle stiffness, and confusion. Report any such reactions to your doctor immediately. If you have Parkinson's disease and are stopping regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.The dosage is based on your medical condition and response to treatment.It may take a few weeks for full effects of this medication to be noticed. Inform your doctor if your symptoms do not improve or if they worsen.

SIDE EFFECTS: Nausea, dizziness, drowsiness, trouble sleeping, constipation, headache, or dry mouth may occur. If these effects persist or worsen, notify your doctor promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (e.g., confusion, depression, hallucinations, memory problems), increased difficulty moving/walking, muscle cramps/spasm, restlessness, decreased sexual ability, increased shakiness (tremor)/stiffness.Tell your doctor immediately if any of these rare but very serious side effects occur: swelling of the ankles/feet, chest pain, compulsive behaviors (e.g., pathological gambling), fever, unusually fast/slow/irregular heartbeat, muscle pain/weakness, unusual tiredness, change in amount of urine, vision changes.Some people taking pramipexole have reported falling asleep suddenly during their usual daily activities (e.g., talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur any time during treatment with pramipexole, including up to 1 year after starting the medication. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk is increased with use of alcohol or other medications that can make you drowsy. You may also develop a sudden drop in blood pressure, which can cause dizziness, nausea, sweating, and fainting. This is more likely when you are first starting the medication, when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.



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