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NEUPRO Safety
and Side Effects

NEUPRO safety and side effects

NEUPRO safety and side effects

NEUPRO® (rotigotine transdermal system) can cause serious side effects, including:

  • Severe allergic reactions. NEUPRO contains a sulfite called sodium metabisulfite. Sulfites can cause severe allergic reactions that are life threatening to some people who are sensitive to sulfites. An allergy to sulfites is not the same as an allergy to sulfa. People with asthma are more likely to be allergic to sulfites. Remove your NEUPRO Patch right away and call your doctor if you have swelling of the lips or tongue, chest pain, or trouble breathing or swallowing.
  • Falling asleep during normal activities. You may fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking NEUPRO. You may suddenly fall asleep without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while doing normal activities while using NEUPRO are greater if you take other medicines that cause drowsiness. Tell your doctor right away if this happens. Before starting NEUPRO, be sure to tell your doctor if you take any medicines that make you drowsy.
  • Changes in blood pressure. NEUPRO can decrease or increase your blood pressure. Lowering of your blood pressure is of special concern. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, this may mean that your blood pressure is decreased. If you notice this, you should contact your doctor. Also, when changing position from lying down or sitting to standing up, you should do it carefully and slowly. Lowering of your blood pressure can happen, especially when you start taking NEUPRO or when your dose is increased.
  • Fainting. Fainting can occur, and sometimes your heart rate may be decreased. This can happen especially when you start using NEUPRO or your dose is increased. Tell your doctor if you faint or feel dizzy.
  • Unusual urges. Some patients using NEUPRO get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble, strong urges to spend money, binge eating, or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your doctor.
  • Changes in heart rate. NEUPRO can increase your heart rate.
  • Skin site reactions. Skin reactions may occur at the site where you apply NEUPRO. Tell your doctor if you get a rash, redness, swelling, or itching that will not go away at the skin site where you have applied NEUPRO.
  • Changes in Restless Legs Syndrome symptoms. NEUPRO may cause Restless Legs Syndrome symptoms to come back (rebound), or become worse or start earlier in the day.

Common side effects

The most common side effects of NEUPRO for Restless Legs Syndrome (RLS) are:

  • Application site reactions
  • Nausea
  • Difficulty falling asleep and staying asleep
  • Sleepiness
  • Headache

In some cases, patients using the NEUPRO Patch experienced localized redness, swelling, or itching where the patch was applied. Rotating the application site daily can reduce the chance of skin reactions. For more details, see Using the NEUPRO Patch.

Patients should report application site reactions that do not go away after a few days, that get worse, or that spread outside the patch site. If there is a skin rash or irritation from the patch, direct sunlight on the area should be avoided until the skin heals. Exposure could lead to changes in skin color.

These are not all the possible side effects of NEUPRO. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UCB, Inc. at UCBCares™ (1-844-599-2273).

Important information to tell your doctor

Before you start using NEUPRO, tell your doctor if you:

  • have breathing problems, including asthma.
  • have daytime sleepiness from a sleep disorder or have unexpected or unpredictable sleepiness or periods of sleep.
  • have mental problems such as schizophrenia, bipolar disorder, or psychosis.
  • feel dizzy, nauseated, sweaty, or faint when you stand up from sitting or lying down.
  • drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while using NEUPRO.
  • have high or low blood pressure.
  • have or have had heart problems.
  • are pregnant or plan to become pregnant. It is not known if NEUPRO will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if NEUPRO passes into your breast milk. You and your doctor should decide if you will use NEUPRO or breastfeed. You should not do both.

Is RLS affecting your life?

Some people have to live their lives around their RLS symptoms. Do you?

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NEUPRO and other medicines may affect each other, causing side effects. NEUPRO may affect the way other medicines work, and other medicines may affect how NEUPRO works.

Especially tell your doctor if you take other medicines that can make you sleepy, such as sleep medicines, antidepressants, or antipsychotics.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Prepare for Your Next Doctor's Appointment

Build a list of key points to discuss with your doctor by selecting items from the list below. Click the "Items to ask my doctor" icon at the top of the screen to view, edit, and print your list at any time.

I have concerns regarding application site reactions.
I have concerns regarding nausea.
I have concerns regarding difficulty falling asleep and staying asleep and sleepiness.
I have concerns regarding headache.
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INDICATION

NEUPRO is a prescription medicine used to treat moderate-to-severe primary Restless Legs Syndrome.

IMPORTANT SAFETY INFORMATION

NEUPRO contains a sulfite called sodium metabisulfite. Sulfites can cause severe allergic reactions that are life threatening to some people who are sensitive to sulfites. People with asthma are more sensitive to sulfites. Remove the patch right away and call your doctor if you have swelling of the lips or tongue, chest pain, or trouble breathing or swallowing.

NEUPRO may make you fall asleep suddenly or without warning while doing normal activities, such as driving, which may result in accidents. Tell your doctor right away if this happens. Drinking alcohol or taking other medicines that cause drowsiness may increase your chances of becoming sleepy while using NEUPRO. Do not drive, use hazardous machinery, or do other dangerous activities until you know how NEUPRO affects you.

NEUPRO can cause decreases in blood pressure, especially when you start or increase your dose. Increases in blood pressure and heart rate, and fainting, also can occur. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, tell your doctor.

Some patients using NEUPRO get urges to behave in a way that is unusual for them, such as unusual urges to gamble, strong urges to spend money, binge eating, or increased sexual urges and behaviors. If you or your family notices you are developing any unusual behaviors, talk to your doctor.

NEUPRO may cause Restless Legs Syndrome symptoms to come back (rebound), become worse, or start earlier in the day.

Skin reactions may occur at the site where you apply NEUPRO. Tell your doctor if you get a rash, redness, swelling, or itching that will not go away.

Avoid exposing the NEUPRO patch you are wearing to heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, and direct sunlight. Too much medicine could be absorbed into your body. Also, do not wear NEUPRO during medical procedures called magnetic resonance imaging (MRI) or cardioversion because this could cause skin burns.

Tell your doctor if you have breathing problems, a sleep disorder, mental problems, high or low blood pressure, or heart problems; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. NEUPRO may not be right for you.

The most common side effects in people taking NEUPRO for Restless Legs Syndrome are application site reactions, nausea, difficulty falling asleep and staying asleep, sleepiness, and headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UCB, Inc. at UCBCares™ (1-844-599-2273).

Please see additional Patient Information about the NEUPRO Patch. This information does not take the place of talking with your healthcare provider about your condition or your treatment.