Rotigotine

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Burning, itching, redness, skin rash, swelling, or soreness at the application site
  • Swelling of the hands, ankles, feet, or lower legs

Less common

  • Bladder pain
  • Bloody or cloudy urine
  • Blurred vision or other changes in vision
  • Difficult, burning, or painful urination
  • Dizziness
  • Frequent urge to urinate
  • Headache
  • Lower back or side pain
  • Nervousness
  • Pounding in the ears
  • Seeing, hearing, or feeling things that are not there
  • Slow or fast heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Nausea
  • Sleepiness or unusual drowsiness
  • Unusual tiredness or weakness
  • Vomiting

Less common

  • Acid or sour stomach
  • Belching
  • Difficulty having a bowel movement (stool)
  • Difficulty with moving
  • Dreaming abnormal
  • Dry mouth
  • Feeling of constant movement of self or surroundings
  • Heartburn
  • Indigestion
  • Loss of appetite
  • Muscle pain or stiffness
  • Pain in the joints
  • Sensation of spinning
  • Sleeplessness
  • Stomach discomfort, upset, or pain
  • Sweating
  • Trouble sleeping
  • Unable to sleep
  • Weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Dizziness, lightheadedness, or fainting may occur with this medicine, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor or dentist before taking any of the above while you are using this medicine.

The patch contains aluminum, which can cause skin burns when used during certain procedures such as magnetic resonance imaging (MRI) or cardioversion. To prevent skin burns, make sure the patch is removed before having these procedures.

Heat may cause too much of the rotigotine to pass through your skin. Do not expose the patch to direct sources of heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or direct sunlight.

If you develop a skin rash or irritation from the patch, do not expose the area to direct sunlight until it heals. Direct sunlight may cause your skin to change color.

If you see snowflake-like crystals formed in the patches, do not use them and contact UCB medical information directly at 1-800-477-7877.

Proper Use

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the skin patch:

  • Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
  • Apply the patch to a clean, dry, and healthy skin area on your stomach, thigh, hip, flank (side of the body between the ribs and the pelvis), shoulder, or upper arm. Choose an area that is not very oily, has little or no hair, and is free of scars, cuts, burns, or any other skin irritation. If you need to put the patch on a hairy area, the area should be shaved at least 3 days before applying the patch. Avoid putting the patch on skin folds, under a waistband, or on areas where it could be rubbed by tight clothing.
  • Press the patch firmly in place with the palm of your hand for about 20 to 30 seconds. Make sure there is good contact with your skin, especially around the edges of the patch.
  • The patch should stay in place, even when you are showering, bathing, or swimming. Apply a new patch if it falls off.
  • After 24 hours, remove the patch. Choose a different place on your skin to apply the new patch. Do not put a new patch in the same place for at least 14 days. Do not leave the patch on for more than 24 hours. It will not work as well after that time and it may irritate your skin.
  • After removing a used patch, fold the patch in half with the sticky sides together. Place the folded, used patch in its protective pouch or in aluminum foil. Make sure to dispose of it out of the reach of children and pets.
  • Try to change the patch at the same time each day. If you forget to change the patch at the usual time, remove the patch you are wearing and put on a new patch. After that, apply a fresh patch at the usual time on the next day.
  • Do not put cream, lotion, ointment, oil, or powder on the skin area where the patch will be placed.
  • Make sure you wash your hands with soap and water before and after applying the patch.

Do not stop using this medicine suddenly without first asking your doctor. You will need to slowly decrease your dose before stopping it completely.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For transdermal dosage form (patch):
    • For Parkinson’s disease:
      • Adults—At first, one 2 milligram (mg) patch once a day. Your doctor will gradually increase your dose to either one 4 mg or 6 mg patch once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rotigotine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rotigotine in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or
  • Blood vessel disease or
  • Dyskinesia (abnormal muscle movements) or
  • Edema (fluid in the hands, lower legs, or feet) or
  • Heart disease (e.g. congestive heart failure) or
  • Hypertension (high blood pressure) or
  • Hypotension (low blood pressure) or
  • Melanoma (skin cancer), history of—Use with caution. May make these conditions worse.
  • Sleep disorders—May worsen sleepiness or episodes of falling asleep during an activity.
  • Sulfite allergy—Use with caution. This medicine contains sodium metabisulfite.

Description

Rotigotine is used to treat the symptoms of Parkinson’s disease, sometimes called shaking palsy. It is a dopamine agonist that helps improve muscle control and reduce muscle stiffness to allow more normal movements of the body.

This medicine was available only with your doctor’s prescription.

Transdermal products containing rotigotine (Neupro®) were withdrawn from the U.S. market by Schwarz Pharma on April 30, 2008.