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SIFROL BI (MIRAPEX) INDICATIONS

Sifrol Bi (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.

Sifrol Bi tablets are used to treat signs and symptoms of Parkinson's disease and for the treatment of Restless Legs Syndrome (RLS).

Sifrol Bi ER extended release tablets are used to treat the signs and symptoms of early and advanced Parkinson's disease.

Sifrol Bi may also be used for other purposes not listed in this medication guide.

SIFROL BI (MIRAPEX) INSTRUCTIONS

Take Sifrol Bi 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 Sifrol Bi in treating Parkinson's disease is different from the dose and timing in treating Restless Legs Syndrome. Follow the directions on your prescription label.

Sifrol Bi 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 Sifrol Bi without first talking to your doctor. You may need to use less and less before you stop the medication completely.

SIFROL BI (MIRAPEX) STORAGE

Take the medicine as prescribed by your doctor.

SIFROL BI (MIRAPEX) STORAGE

Store Sifrol Bi at room temperature away from moisture and heat.

SIFROL BI (MIRAPEX) MORE INFO:

Active ingredient: Pramipexole

You should not take Sifrol Bi if your are allergic to pramipexole. Some people taking Sifrol Bi 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 Sifrol Bi, 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 Sifrol Bi. 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 Sifrol Bi.

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 Sifrol Bi will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Sifrol Bi. It is not known whether pramipexole passes into breast milk or if it could harm a nursing baby. Do not use Sifrol Bi without telling your doctor if you are breast-feeding a baby.

Sifrol Bi 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.

Important safety information:

Some people taking Sifrol Bi 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.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking Sifrol Bi. Talk with your doctor if you believe you have any intense or unusual urges while taking Sifrol Bi.

If you are taking Sifrol Bi for rest leg syndrome (RLS), 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 Sifrol Bi without first talking to your doctor. You may need to use less and less before you stop the medication completely.

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.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Sifrol Bi. Tell your doctor if you regularly use any of these other medicines. Drinking alcohol can increase certain side effects of Sifrol Bi. Sifrol Bi 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.

Get emergency medical help if you have any of these signs of an allergic reaction to Sifrol Bi: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Sifrol Bi 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;

hallucinations;

muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;

chest discomfort, dry cough, feeling short of breath;

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 Sifrol Bi 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.

This is not a complete list of Sifrol Bi side effects and others may occur. Call your doctor for medical advice about side effects.



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