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Rotigotine (Transdermal) (Patch, Extended Release)

Rotigotine (Absorbed through the skin)
Rotigotine (roe-TIG-oh-teen)Treats symptoms of Parkinson disease, such as jerky muscle movements, muscle stiffness, and slow movement. Also treats restless legs syndrome (RLS).
Neupro

When This Medicine Should Not Be Used:
Do not use this medicine if you have had an allergic reaction to rotigotine.

How to Use This Medicine:
Patch

  • Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to. Try to change the patch at the same time each day.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Wash your hands with soap and water before and after applying a patch.
  • Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been cut by accident. Remove the protective liner, and put the patch on immediately after you open the package.
  • The patient instructions will show the body areas where you can wear the patch. When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one. Do not put a new patch in the same place for at least 14 days.
  • Apply the patch to clean, dry skin that has very little or no hair. Do not put the patch over burns, cuts, irritated, or oily skin. Avoid putting the patch on skin folds, under a waistband, or on areas where it could be rubbed by tight clothing. If you need to put the patch on a hairy area, the area should be shaved at least 3 days before you apply the patch.
  • Do not put cream, lotion, ointment, oil, or powder on the skin area where the patch will be placed.
  • Put on a new patch if the old one has fallen off and cannot be reapplied.
  • After you remove the patch, wash the site with soap and water to remove any drug or adhesive. You may also use baby or mineral oil to remove any excess medicine.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are using metoclopramide (Reglan®), medicine to treat mental illness (such as haloperidol, mesoridazine, pimozide, prochlorperazine, quetiapine, thioridazine, ziprasidone, Compazine®, Geodon®, Haldol®, Mellaril®, Orap®, Serentil®, or Seroquel®), or an antidepressant (such as amitriptyline, fluoxetine, nortriptyline, Elavil®, Pamelor®, Prozac®, Sarafem®, Vivactil®).
  • Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
  • Do not drink excess alcohol while you are using this medicine.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, heart or blood vessel disease, congestive heart failure, asthma, dyskinesia (abnormal muscle movements), lung disease, melanoma, or psychotic mental illness.
  • Tell your doctor if you have a sulfite allergy. This medicine contains sodium metabisulfite.
  • Rarely, this medicine has caused sudden sleep attacks in some people. You might fall asleep without warning during normal daily activities, such as driving or eating. This is more likely to happen if you are also using other medicines that make you sleepy or if you have a sleep disorder. However, many people will feel tired or sleepy but do not have a sudden sleep attack. Tell your doctor about any sleepiness or tiredness that you have.
  • This medicine may change your blood pressure or heart rate. Make sure your doctor knows if you already have high or low blood pressure. Tell your doctor if you feel faint or lightheaded, or have a fast or pounding heart beat.
  • This medicine may make you dizzy, lightheaded, or drowsy, especially when you first begin to use it. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you are dizzy.
  • This medicine may cause agitation, irritability, confusion, aggressiveness, or hostility. It may also cause you to see, hear, or feel things that are not there. Tell your doctor right away if you or your caregiver notice any of these side effects.
  • This medicine may cause impulse behavior changes, such as strong urges to gamble, spend money, or binge eat, or an increased sex drive.
  • Your doctor will need to check your skin regularly for melanoma while you are receiving this medicine.
  • Remove this patch before you have a medical procedure that involves electricity, such as MRI or cardioversion, because the patch contains aluminum. Make sure any doctor who treats you knows that you have this patch.
  • Heat may cause your skin to absorb too much of this medicine. Keep the patch away from heat, especially from heating pads, electric blankets, hot tubs, or direct sunlight.
  • Tell your doctor if you develop redness, swelling, or itchiness from the patch that lasts longer than a few days, becomes more severe, or spreads to areas outside the application site. Also, do not expose the area to direct sunlight until it heals. Direct sunlight may cause skin discoloration.
  • This medicine may worsen RLS symptoms during or after treatment.
  • This medicine may cause new or worsened Parkinson disease symptoms, such as jerky muscle movements, during treatment.
  • Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Changes in vision
  • Headache
  • New or worsened achy legs, or urge to move your legs
  • New or worsened jerky muscle movement that you cannot control (often in your face, tongue, arms, or legs)
  • Lightheadedness, dizziness, or faint
  • Rapid weight gain, or swelling in your hands, ankles, or feet
  • Severe drowsiness, suddenly falling asleep
  • Skin rash, itching, swelling, or redness where the patch is worn
  • Unusual behavior, mood changes, confusion, or seeing or hearing things that are not there

If you notice these less serious side effects, talk with your doctor:

  • Loss of appetite
  • Nausea, vomiting, or upset stomach
  • Sweating
  • Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088