Rotigotine, Transdermal

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KEY POINTS

• This medicine is in a patch put on the skin to treat the symptoms of Parkinson’s disease or restless legs syndrome. Use it exactly as directed.
• This medicine may cause you to suddenly fall asleep without warning, have unusual urges, or cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: dopamine agonist

Generic and brand names: rotigotine, transdermal; Neupro

What is this medicine used for?

This medicine is a patch that you put on your skin to treat the symptoms of Parkinson’s disease. It is also used to treat moderate to severe restless legs syndrome.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to sulfites
• Breathing problems or lung disease such as asthma
• Edema (fluid buildup)
• Heart disease, heart failure, or a fast heartbeat
• High or low blood pressure
• Mental health problems such as schizophrenia or hallucinations
• Tardive dyskinesia

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Carefully follow the instructions for using this medicine. Your provider may adjust the dosage to find the one that is best. Do not use more or less or use it longer than prescribed. Do not stop using this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually.

Check with your healthcare provider before using this medicine in children under age 18.

Be sure you know when to use the medicine and how much medicine you should use. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

1. Wash your hands before and after using this medicine. Apply the medicine patch as soon as it is removed from the protective pouch. Put the sticky side of the patch on clean, dry skin on your belly, thigh, hip, shoulder, or upper arm. Hold the patch in place with your hand for at least 30 seconds. Avoid areas where bending or rubbing might happen. Choose a spot with no hair or broken skin. Do not put it where your clothing might rub it off, such as your waistline. Do not apply the patch to oily, broken, or irritated skin, or to your breasts. Do not place the patch where it would be exposed to sunlight. Make sure all the edges of the patch are firmly attached. Do not cut or tear the patch.
2. Apply the patch 1 time a day at the same time each day. Apply the patch to a different place on your skin each time you apply a new patch. Wait at least 14 days before using that place again.
3. If the patch comes off, try to put it back on. If it won't stick, put on a new patch but follow your original schedule. Wash your hands after handling a patch.
4. Remove the patch slowly and carefully to avoid irritating your skin. Gently rub the area with mineral oil, cream, or lotion to remove any medicine that remains on your skin after removing the patch. Do not use alcohol or nail polish remover because it can irritate your skin.
5. Fold used patches so that they stick to themselves with the medicine inside. Then dispose of them safely away from children and pets.

You may bathe, swim, or shower while wearing the patch. However, do not use a heating pad, electric blanket, heat lamp, sauna, hot tub, or other direct heat where you apply the patch. Heat may increase the amount of medicine released from the patch and could result in an overdose.

What if I miss a dose?

If you miss a dose of this medicine, apply it as soon as possible. If it is almost time to put on your next patch, wait until then to apply the patch and skip the one you missed. Do not apply extra patches to make up for the missed dose. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider. You may need to start the medicine again at a lower dose.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, involuntary movements, dizziness, fainting, confusion, seizures, hallucinations (seeing, hearing, or feeling things that are not real).

What should I watch out for?

This medicine may increase your blood pressure and heart rate. Talk with your healthcare provider about this.

This medicine may make you dizzy, especially when you first start taking the medicine or with dose changes. You may feel dizzy or faint when you get up quickly after sitting or lying down. Avoid sudden changes in position. Get up slowly after sitting or lying down.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

This medicine may also cause drowsiness or cause you to suddenly fall asleep during daily activities. Sometimes this may happen without warning. If you fall asleep while riding in a car, watching television, or during other activities, contact your healthcare provider. Do not drive or operate machinery until you know how this medicine affects you.

If you take this medicine for RLS, your symptoms may start earlier in the day, or may get worse when you start taking this medicine. Talk with your provider about this.

This medicine may cause strong urges, such as to gamble, or have sex. Talk with your healthcare if you have unusual urges while taking this medicine.

If you get a skin rash or irritation from the medicine patch, stay out of direct sunlight until your skin heals.

Some people taking medicines for Parkinson's disease have developed skin cancer (melanoma). Talk to your healthcare provider about this and what to watch for. You may need to have regular skin exams.

Your healthcare provider will want to check you regularly to see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. The patch may need to be removed before certain tests or procedures such as MRIs.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe confusion; hallucinations (seeing or hearing things that are not there); unusual urges or behavior; lightheadedness or fainting; rash or unusual skin changes; fast or irregular heartbeat; trouble breathing or shortness of breath; sudden or severe drowsiness; uncontrolled muscle movements; stiff muscles; swelling in feet, legs, hands or arms, or any unexplained swelling; itching, burning, or redness of the skin that continues or gets worse.

Other: Dizziness; drowsiness; tiredness; headache; nausea; vomiting; stomach pain; diarrhea; constipation; loss of appetite; trouble sleeping or abnormal dreams; dry mouth; increased sweating; itching, burning, or redness of the skin where the patch was applied.

Important: Other side effects have been reported with long-term treatment. Report all ill effects to your healthcare provider.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Doxepin (Silenor)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as droperidol (Inapsine), metoclopramide (Metozolv, Reglan), prochlorperazine (Compro), and promethazine
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), pentazocine (Talwin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.