Rotigotine (transdermal)

Rotigotine (transdermal) is a skin patch that treats symptoms of Parkinson's disease, including stiffness, tremors, muscle spasms, and poor muscle control.

Rotigotine is also used to treat restless legs syndrome (RLS).

Rotigotine may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Apply the patch to clean, dry, and hairless skin. Avoid placing the patch where it will be rubbed by a waistband or tight clothing. Press the patch firmly into place for about 30 seconds. You may leave the patch on while bathing, showering, or swimming.

Remove the skin patch after 24 hours and replace it with a new one. Choose a different place on your body to wear the patch each time you put on a new one. Do not use the same skin area twice within 14 days.

If a patch falls off, put a new patch on a different place on your body and wear it the rest of the day. Then replace the patch the next day at your regular time.

Wash your hands with soap and water after applying or removing the patch.

Keep used and unused rotigotine skin patches out of the reach of children or pets.

If you are using rotigotine for restless legs syndrome, call your doctor if your symptoms get worse, or if they start earlier in the day than usual.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using rotigotine.

The rotigotine patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

Do not stop using rotigotine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using rotigotine.

Keep the skin patch in its sealed pouch until you are ready to use it. Store the pouches at room temperature away from heat and moisture.

After removing a patch, fold it in half so it sticks together and throw it away in a place where children or pets cannot get to it.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are using.

You should not use rotigotine if you are allergic to it.

Tell your doctor if you have ever had:

• asthma or a sulfite allergy;
• high or low blood pressure;
• heart problems;
• kidney disease;
• schizophrenia, bipolar disorder, or psychosis;
• narcolepsy or other sleep disorder; or
• if you feel light-headed or nauseated when you stand up.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether rotigotine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using rotigotine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Rotigotine may cause serious side effects. Call your doctor at once if you have:

• severe skin irritation that does not clear up within several hours after removing a skin patch;
• extreme drowsiness, falling asleep suddenly, even after feeling alert;
• a light-headed feeling, like you might pass out;
• agitation, confusion, hallucinations, paranoia (most commonly in elderly people);
• fast heart rate;
• increased sexual urges, unusual urges to gamble, or other intense urges;
• unusual thoughts or behavior; or
• uncontrolled muscle movements.

Some people using rotigotine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

Common side effects of rotigotine may include:

• nausea, vomiting, loss of appetite;
• headache, dizziness, drowsiness;
• vision problems;
• swelling in your hands or feet, rapid weight gain;
• increased sweating;
• sleep problems (insomnia); or
• redness, itching, or swelling where a patch was worn.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Parkinson's Disease:

Initial doses: Early-stage Parkinson's disease: Apply 2 mg topically once a dayAdvanced-stage Parkinson's disease: Apply 4 mg topically once a dayMaintenance dose: Increase weekly in 2 mg/24 hours increments if additional therapeutic effect is needed Lowest effective dose: 4 mg/24 hoursMaximum dose for Early-stage Parkinson's disease: 6 mg/24 hoursMaximum dose for Advanced-stage Parkinson's disease: 8 mg/24 hoursComments: -Upon discontinuation, reduce the daily dose by a maximum of 2 mg every 24 hours, if possible; reduce the dose every other day until withdrawal is complete. Use: Treatment of Parkinson's disease

Usual Adult Dose for Restless Legs Syndrome:

Initial dose: Apply 1 mg topically once a dayMaintenance dose: Increase weekly in 1 mg/24 hours increments if additional therapeutic effect is needed Lowest effective dose: 1 mg/24 hoursMaximum dose: 3 mg/24 hoursComments: -Upon discontinuation, reduce the daily dose by a maximum of 1 mg every 24 hours, if possible; reduce the dose every other day until withdrawal is completeUse: Treatment of moderate-to-severe primary Restless Legs Syndrome

If you forget to change a patch on the scheduled day, take off the old patch and put on a new one as soon as you remember. Wear the new patch until it is time to change your patch again. Do not change your schedule, even if you wear the new patch for less than 24 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drinking alcohol with rotigotine can increase side effects.

Avoid driving or doing anything dangerous until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too quickly from a sitting or lying position, or you may feel dizzy.

Avoid applying a patch to irritated skin, or to skin where you have used lotion, oil, cream, ointment, or powder.

Do not expose the skin patch to heat while you are wearing it. This includes a hot tub, heating pad, sauna, or heated water bed. Heat can increase the amount of drug absorbed through your skin and may cause harmful effects.

Using rotigotine with other drugs that can cause drowsiness may increase this effect. Consult your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may influence how rotigotine works, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all your current medications and any medicine you begin or stop taking.