rotigotine 1 mg/24 hour transdermal 24 hour patch

Generic name:
Rotigotine patch - transdermal

Pronunciation
(roe-TIG-oh-teen)

Brand name(s)
Neupro

Rotigotine is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. Rotigotine is also used to treat restless legs syndrome (RLS).

Rotigotine is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

Read the Patient Information Leaflet if available from your pharmacist before you start using rotigotine and each time you get a refill. Learn how to use this patch properly. If you have any questions, ask your doctor or pharmacist.

Do not open the sealed pouch until ready to use. Do not cut the patch or use the patch if it appears broken, cut, or damaged. Open the pouch and remove the patch. Peel off the backing from the patch as directed and apply the patch to a clean, dry, and hairless area of the skin on the front of the abdomen, thigh, hip, side of the lower back (flank), shoulder, or upper arm. Press the patch firmly in place for about 30 seconds to make sure it stays on. Do not apply the patch on oily, broken, or irritated skin. Do not use creams, lotions, ointments, oils, or powders on skin where you are applying the patch. Avoid applying the patch to areas of the skin where it might be easily rubbed off (such as on skin folds or under tight clothing). If applying to a hairy area, shave the area at least 3 days before applying the patch. Wash your hands with soap and water after handling the patch. Do not touch your eyes or other objects until your hands are washed.

The patch is usually worn for 1 day and replaced. Apply the patch to a different area on your body each time to avoid irritation. Wait at least 14 days before applying the patch to the same area. If the patch irritates the skin, protect the area from direct sunlight until the skin is completely healed. Sunlight may cause the irritated skin to change color.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects (such as nausea, dizziness), your doctor may direct you to start at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, change your patch at the same time each day.

To prevent the patch from coming off, use care while showering, bathing, and exercising. If the edges of the patch start to loosen, you may tape it in place with bandage tape. If the patch falls off, apply a new patch to a different area, and change the patch at your usual time the next day.

When changing your patch, carefully remove the old patch, fold it in half with the sticky side together, and throw it away in the trash away from children and pets. Do not touch the sticky side with your fingers. Wash the application area with soap and water. Use baby oil or mineral oil to remove any leftover stickiness. Do not use solvents such as alcohol or nail polish remover. Always wash your hands after handling the patch, being careful not to touch your eyes or other objects until after you have washed your hands.

Do not stop using this medication without consulting your doctor. Some conditions may become worse when this medication is suddenly stopped. Also, if you suddenly stop using this medication, you may have withdrawal symptoms (such as anxiety, depression, confusion, fever, muscle stiffness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used rotigotine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Tell your doctor if your condition does not get better or if it gets worse.

Nausea, vomiting, loss of appetite, dizziness, drowsiness, lightheadedness, tiredness, trouble sleeping, increased sweating, headache, or redness/itching/swelling at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as confusion, agitation, hallucinations)
• severe dizziness
• fainting
• unusual strong urges (such as increased gambling, increased sexual urges)
• swelling ankles/feet
• unusual weight gain
• fast heartbeat
• new or worsening uncontrolled movements

Some people using rotigotine have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with rotigotine even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.

This medication may increase or decrease your blood pressure. You may develop a sudden drop in blood pressure that can cause dizziness, lightheadedness, nausea, sweating, and fainting. This is more likely when you first start the medication, when your dose is increased, or when you get up suddenly. To reduce your risk, get up slowly when rising from a sitting or lying position. Talk to your doctor if you need to check your blood pressure while using this medication.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using rotigotine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• asthma
• sleep disorders (such as sleep apnea, narcolepsy)
• low/high blood pressure
• heart disease (such as heart failure)
• kidney disease
• mental/mood disorders (such as schizophrenia)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section.

While wearing your patch, avoid exposing it to direct heat (such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds, or prolonged direct sunlight). Heat may cause more drug to be released into your body, increasing the risk of side effects.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you are going to have an MRI test or cardioversion, tell the health care provider that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI or cardioversion. Ask your doctor whether you will need to remove your patch before the procedure and apply a new patch afterward, and how to do so properly.

Older adults may be more sensitive to the side effects of this drug, especially mental/mood changes (such as hallucinations)

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: mental/mood changes (such as confusion, hallucinations), uncontrolled movements, seizures.

Do not share this medication with others.

If you forget to change the patch, change it as soon as you remember. Do not double the dose to catch up. Then go back to your usual schedule for changing your patch.

Store the patches at room temperature. Do not open the pouch until you are ready to use the patch. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. (See also How to Use section.)

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.