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RYTARY™ Patient Walking with Family

Frequently Asked Questions About RYTARY

What is RYTARY?

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RYTARY is an extended-release carbidopa-levodopa prescription medicine for the treatment of Parkinson's disease.

How should I store RYTARY?1

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Store RYTARY at room temperature [77˚F (25˚C)].
Store in a tightly closed container, protected from light and moisture.
Keep RYTARY capsules and all medicines out of the reach of children.
If you take RYTARY with applesauce, take it immediately. Do not save it for later.
Use RYTARY before the expiration date printed on the bottle.

I have early stage Parkinson's. Will RYTARY help?

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In a clinical study of RYTARY, patients in the early stages of Parkinson's disease who took RYTARY experienced significant
improvement in their ability to move around and complete daily tasks.* You should consult with your doctor about any treatment,
including RYTARY.

* In a clinical study of patients with early Parkinson's disease, based on a scale to measure activities of daily living and ability to move (called the Unified Parkinson's Disease Rating Scale or UPDRS).

What are the most serious side effects?1

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RYTARY can cause serious side effects, including:
Falling asleep during normal activities and sleepiness. You may fall asleep while doing daily activities such as driving, doing
physical tasks, or using hazardous machinery while taking RYTARY. You may suddenly fall asleep without being drowsy or
without warning. This may result in having accidents. Do not drive, operate machinery, or do anything that requires you to be
alert until you know how RYTARY affects you. Sleepiness may first occur as late as one year after initiation of treatment. Tell
your healthcare provider right away if you fall asleep while you are doing activities such as talking with people, eating, or
driving; or if you feel sleepier than is normal for you.

Extremely high fever and confusion. Some serious side effects that may occur with RYTARY include symptoms resembling
neuroleptic malignant syndrome (a condition characterized by fever, confusion and muscle stiffness); low blood pressure;
severe diarrhea; and severe dyskinesias (abnormal involuntary movements). Do not quickly lower or change your RYTARY dose
or suddenly stop taking it altogether without talking to your healthcare provider as this may result in developing these
symptoms. Tell your healthcare provider right away if you stop taking RYTARY for any reason or have any of these symptoms.
Do not start taking RYTARY again before speaking with your healthcare provider.

Cardiovascular Events. Some patients with a history of heart disease who took RYTARY in clinical trials experienced cardiac
side effects. Tell your healthcare provider if you have a history of heart disease.

Hallucinations and psychosis. RYTARY can cause or worsen psychosis including hallucinations (seeing or hearing things that
are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not
real), and disorganized thinking. The chances of having hallucinations or these other psychotic-like changes are higher in
people with Parkinson's disease who are elderly. If you have hallucinations or other psychotic-like behaviors, talk with your
healthcare provider.

Unusual urges. Some patients taking certain medicines to treat Parkinson's disease have intense urges to gamble, increased
sexual urges, other intense urges, and the inability to control those urges. If you or your family members notice that you are
developing unusual urges or behaviors, talk to your healthcare provider.

Dyskinesia. You may develop abnormal involuntary movements while taking RYTARY.

Call your healthcare provider or get medical care right away if you have any of the above symptoms. Your healthcare
provider will tell you if you should stop treatment with RYTARY and if needed, tell you how to discontinue RYTARY.

What are the most common side effects with RYTARY?1

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The most common side effects that may occur with RYTARY include nausea, dizziness, headache, sleeplessness, abnormal
dreams, dry mouth, abnormal involuntary movements, anxiety, constipation, vomiting, and low blood pressure upon rising. Rise
slowly after sitting or lying down for a prolonged period.


Tell your healthcare provider if you have any side effects while taking RYTARY. He or she can make adjustments that may
reduce those effects. These are not all the possible side effects of RYTARY capsules. For more information, ask your doctor or
pharmacist, or see the Full Prescribing Information.


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. To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at 1-877-994-6729.

Can a change in my diet help me with Parkinson's disease?

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A healthy diet may be beneficial for your overall well-being. There is no current diet specifically recommended for people with
Parkinson's disease. However, good nutrition is important at any age. Be sure to eat a balanced diet, including fiber, drink
enough water, and tell your doctor about all the medications, vitamins, and nutritional supplements you are taking.
2
Iron salts (such as in multivitamin tablets) may reduce the amount of levodopa available in the body, therefore avoid taking an
iron supplement at the same time as RYTARY.

Do I need to eat differently when taking RYTARY?

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RYTARY may be taken with or without food. However, foods rich in protein or amino acids may decrease the absorption of
levodopa. Also, keep in mind that a high-fat, high-calorie meal may delay the absorption of RYTARY by about 2 hours. For this
reason, consideration should be given to taking the first dose of the day about 1 to 2 hours before eating. Do not chew, divide,
or crush RYTARY. If you have any questions talk to your doctor about when to take your medication.

Do not drink alcohol while taking RYTARY capsules. It can increase your chances of feeling sleepy or falling asleep when you
should be awake.

Who should not use RYTARY?1

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You should not take RYTARY with an antidepressant medication class known as nonselective monoamine oxidase (MAO) inhibitors, as
the combination of these two drugs may cause hypertension.

What happens to RYTARY after you take it?

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After you swallow the capsule, the medication is released from the capsule and is absorbed into your body. The medication
stays in your body for about 4 to 5 hours.
1

Why is the dose of levodopa higher in RYTARY?

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Because of the way RYTARY is formulated, the dose of levodopa in RYTARY may be higher than what you have received before.

What can I do if I have trouble swallowing?

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If you have difficulty swallowing capsules, the capsule may be carefully opened and the entire contents sprinkled on a small
amount of applesauce (1 to 2 tablespoons). Then you should take the entire RYTARY contents immediately.
1

I don't live near a city. Where can I find a support group?

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There are many options both online and through local organizations. Start by asking your doctor or nurse, a social worker, or a
chaplain. Many states have their own Parkinson's Association chapters for education and support. Contact community centers,
libraries, churches, synagogues, mosques, or temples in your area. Online support groups are available as well. Support is out there.
3

Why wait?
Ask your doctor today if RYTARY is right for you.

IMPORTANT SAFETY INFORMATION

Do not take RYTARY with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors because taking these two drugs within two weeks of each other can result in high blood pressure.

Taking RYTARY may result in falling asleep while engaged in normal activities, even without warning and as late as one year after starting to take RYTARY. Other sedating medicines and alcohol taken together with RYTARY may have additional sedative effects. Tell your healthcare provider if you have any kind of sleep disorder or are experiencing drowsiness or sleepiness.

Some side effects of taking RYTARY including sleepiness and dizziness may affect your ability to drive or operate machinery. Do not drive a car, operate a machine, or do anything that requires you to be alert until you know how RYTARY affects you.

Talk to your healthcare provider before you lower the dose or stop taking RYTARY, as this may result in serious side effects. Call your healthcare provider immediately if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness.

Make sure to tell your healthcare provider if you have any heart conditions, especially if you have had a heart attack or experience irregular heartbeat. Some people with a history of or risk factors for heart disease have experienced heart problems while taking RYTARY.

Some patients taking RYTARY can experience hallucinations (unreal visions, sounds, or sensations) or abnormal thoughts and behaviors (such as excessive suspicion, believing things that are not real, confusion, agitation, aggressive behavior, and disorganized thinking). If you have hallucinations or abnormal thoughts or behaviors, talk with your healthcare provider.

Some patients taking certain medicines to treat Parkinson’s disease have intense urges to gamble, increased sexual urges, other intense urges, and the inability to control those urges. If you or your family members notice that you are developing unusual urges or behaviors, talk to your healthcare provider.

Tell your healthcare provider if abnormal involuntary movements appear or get worse during treatment with RYTARY.

Tell your healthcare provider if you have ever had an ulcer, because RYTARY may increase your chances of having bleeding in your stomach.

Tell your healthcare provider if you have glaucoma, because RYTARY may increase the pressure in your eyes.

Parkinson’s disease patients are at an increased risk of developing melanoma, a form of skin cancer. See your healthcare provider for regular skin examinations when taking RYTARY.

The most common side effects that may occur with RYTARY include nausea, dizziness, headache, sleeplessness, abnormal dreams, dry mouth, abnormal involuntary movements, anxiety, constipation, vomiting, and low blood pressure upon rising. Rise slowly after sitting or lying down for a prolonged period.

In post marketing use, some patients taking RYTARY have experienced suicidal thoughts or have attempted suicide. A causal relationship has not been established. Tell your healthcare provider if you have thoughts of suicide or have attempted suicide.

Tell your healthcare provider if you have any side effects while taking RYTARY. He or she can make adjustments that may reduce these effects.

Notify your healthcare provider if you become pregnant or intend to become pregnant during therapy or if you intend to breast-feed or are breast-feeding an infant.

Make sure you tell your healthcare provider about all of the prescription and non-prescription medications you take, including supplements, and especially those for Parkinson’s disease, heart disease, blood pressure, abnormal thoughts, tuberculosis, and sleep problems, and supplements containing iron. Do not take other carbidopa-levodopa preparations with RYTARY without consulting your healthcare provider.

Be sure to take your medicine as instructed. You may take RYTARY with or without food; however, taking RYTARY with food may decrease or delay its effect. For this reason consider taking the first dose of the day about 1 to 2 hours before eating. Swallow RYTARY whole; do not chew, divide, or crush. If you have difficulty swallowing the capsule, twist apart both halves and sprinkle the entire contents of both halves of the capsule on a small amount of applesauce (1 to 2 tablespoons). Consume the mixture immediately. Do not store the drug/food mixture for future use.

Note: The above information for patients being treated with RYTARY is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

INDICATION

RYTARY is a prescription medication that contains a combination of carbidopa and levodopa for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease resulting from carbon monoxide or manganese poisoning.

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. To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at 1-877-994-6729.

Please read the full Prescribing Information For more information go to RYTARY.com and/or talk to your healthcare provider.

References:

1. RYTARY [package insert]. Hayward, CA: Impax Laboratories, Inc.; 2015.
2. Traviss K. Nutrition and Parkinson’s disease: what matters most? Parkinson’s Disease Foundation website. http://www.pdf.org/en/winter06_07_Nutrition_and_Parkinsons.
Accessed December 12, 2014.
3. Stress management—Support groups: make connections, get help. Mayo Clinic website.
http://www.mayoclinic.org/healthy-living/stress-management/in-depth/support-groups/art-20044655. Accessed December 12, 2014.