Uses of Rotigotine:

• It is used to treat Parkinson's disease.
• It is used to treat restless leg syndrome.

What do I need to tell my doctor BEFORE I take Rotigotine?

• If you have an allergy to rotigotine or any other part of rotigotine.
• If you are allergic to rotigotine; any part of rotigotine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take rotigotine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Rotigotine?

• Tell all of your health care providers that you take rotigotine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how rotigotine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Check blood pressure and heart rate as the doctor has told you.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• The patch may have metal. Take off the patch before an MRI or cardioversion.
• Do not stop taking rotigotine all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop rotigotine, you will want to slowly stop it as ordered by your doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Avoid use of heat sources (such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds). Avoid long, hot baths or sunbathing. Your temperature may rise and cause too much drug to pass into your body.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using rotigotine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Parkinson's disease:

• The chance of a type of skin cancer called melanoma may be raised in people with Parkinson's disease. It is not known if rotigotine may also raise the chance. Have skin exams while you take rotigotine. Talk with your doctor.

Restless leg syndrome:

• Tell your doctor if your signs become worse or start earlier in the day.
• Have your skin checked as you have been told by your doctor.

How is this medicine (Rotigotine) best taken?

Use rotigotine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not use patches that are cut or do not look right.
• Wash your hands before and after use.
• Put patch on clean, dry, healthy skin on the belly, hip, side, shoulder, upper leg, or upper arm.
• Put patch on at the same time of day.
• Do not put on skin that is irritated or damaged. Do not put on an area with skin folds or skin that will be rubbed by tight clothes.
• Do not put on skin where you have just used creams, oils, lotions, powder, or other skin products. The patch may not stick as well.
• Shave hair at a site 3 days before putting a patch on it.
• Press patch firmly in place for 30 seconds when putting it on.
• Move the patch site with each new patch. Do not put on the same site for 14 days.
• Be careful to not knock loose the patch while bathing or showering.
• If the patch falls off, put a new one on.
• If the patch loosens, put tape ONLY on the edges of the patch to hold it in place.
• When patch is taken off, wash site with soap and water.
• Keep using rotigotine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Put on a missed patch as soon as you think about it after taking off the old one.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on more than 1 patch at a time.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
• A skin lump or growth.
• Change in color or size of a mole.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Dizziness or passing out.
• Mood changes.
• Hallucinations (seeing or hearing things that are not there).
• Change in how you act.
• Feeling confused.
• Fever.
• Muscle pain.
• Muscle stiffness.
• Trouble controlling body movements that is new or worse.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Change in eyesight.
• Change in sex interest.
• Very bad irritation where rotigotine is used.
• Some people have fallen asleep during activities like driving, eating, or talking. Some people did not feel sleepy and felt alert right before falling asleep. This has happened up to 1 year after rotigotine was started. If you fall asleep during activities, do not drive or do other tasks or actions that call for you to be alert while you take rotigotine. Call your doctor right away if this happens or you feel very sleepy.

What are some other side effects of Rotigotine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Constipation.
• Not hungry.
• Diarrhea.
• Feeling sleepy.
• Strange or odd dreams.
• Headache.
• Sweating a lot.
• Feeling tired or weak.
• Trouble sleeping.
• Joint pain.
• Irritation where rotigotine is used.
• Dry mouth.
• Weight gain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Rotigotine?

• Store at room temperature.
• Store patches in pouch until ready for use.
• Store in a dry place. Do not store in a bathroom.
• After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about rotigotine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.