Rotigotine transdermal

You should not use rotigotine if you are allergic to it.

To make sure rotigotine is safe for you, tell your doctor if you have:

• asthma or sulfite allergy;

• high or low blood pressure;

• heart disease, congestive heart failure, or heart rhythm disorder;

• kidney disease;

• a history of mental illness or psychosis;

• narcolepsy or other sleep disorder; or

• tremors (dyskinesia) or uncontrolled muscle movements.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether rotigotine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether rotigotine passes into breast milk or if it could harm a nursing baby. Rotigotine may also slow breast milk production. Tell your doctor if you are breast-feeding a baby.

Usual Adult Dose for Parkinson's Disease:

Initial doses:
Early-stage Parkinson's disease: Apply 2 mg topically once a day
Advanced-stage Parkinson's disease: Apply 4 mg topically once a day

Maintenance dose: Increase weekly in 2 mg/24 hours increments if additional therapeutic effect is needed
Lowest effective dose: 4 mg/24 hours
Maximum dose for Early-stage Parkinson's disease: 6 mg/24 hours
Maximum dose for Advanced-stage Parkinson's disease: 8 mg/24 hours

Comments:
-Upon discontinuation, reduce the daily dose by a maximum of 2 mg every 24 hours, if possible; reduce the dose every other day until withdrawal is complete.

Use: Treatment of Parkinson's disease

Usual Adult Dose for Restless Legs Syndrome:

Initial dose: Apply 1 mg topically once a day
Maintenance dose: Increase weekly in 1 mg/24 hours increments if additional therapeutic effect is needed
Lowest effective dose: 1 mg/24 hours
Maximum dose: 3 mg/24 hours

Comments:
-Upon discontinuation, reduce the daily dose by a maximum of 1 mg every 24 hours, if possible; reduce the dose every other day until withdrawal is complete

Use: Treatment of moderate-to-severe primary Restless Legs Syndrome

Rotigotine transdermal patch is used to treat 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.

Rotigotine is also used to treat a condition called Restless Legs Syndrome (RLS). RLS is a neurologic disorder that affects sensation and movement in the legs. This results in an irresistible feeling of wanting to move your legs to make them comfortable.

rotigotine is available only with your doctor's prescription.

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

rotigotine may cause some people to become dizzy, drowsy, sleepiness, or trouble with thinking. Make sure you know how you react to rotigotine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think well. If these side effects are especially bothersome, check with your doctor.

Dizziness, lightheadedness, or fainting may occur with rotigotine, 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.

rotigotine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as confusion, delusions, feeling aggressive or hostile, or seeing, hearing, or feeling things that are not there (hallucinations). If you or your caregiver notice any of these side effects, tell your doctor right away.

Some people who have used rotigotine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased sex drive while using rotigotine.

rotigotine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet, tingling of the hands or feet, or unusual weight gain or loss.

rotigotine 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 rotigotine.

It is important that your doctor check your skin for melanoma (cancer) regularly while you are using rotigotine.

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 that lasts longer than a few days, becomes more severe, or spreads to areas outside the application site, tell your doctor. Also, do not expose the area to direct sunlight until it heals. Direct sunlight may cause your skin to change color.

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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, depression, 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.

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, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic 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.

Commonly reported side effects of rotigotine include: application site reaction, insomnia, nausea, and vomiting. Other side effects include: dizziness, dyspepsia, increased blood pressure, increased heart rate, orthostatic hypotension, and orthostatic dizziness. See below for a comprehensive list of adverse effects.

Applies to rotigotine: transdermal patch extended release

Along with its needed effects, rotigotine 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 while taking rotigotine:

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

• 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

Get emergency help immediately if any of the following symptoms of overdose occur while taking rotigotine:

• Confusion
• convulsions
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• nausea
• sweating
• unusual tiredness or weakness
• vomiting

Some side effects of rotigotine 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:

• Sleepiness or unusual drowsiness

• 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
• trouble sleeping
• unable to sleep
• weight loss

No adjustment recommended.