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Possible RYTARY Side Effects

What are some possible side effects of RYTARY?

RYTARY can cause serious side effects, including1:

  • 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. Tell your healthcare provider if abnormal
    involuntary movements appear or get worse.
  • Bleeding from Ulcer Disease. If you have ever had an ulcer, RYTARY may increase your chances of having bleeding in your stomach.
    Talk to your healthcare provider about gastrointestinal bleeding.
  • Glaucoma. If you have glaucoma, RYTARY may cause you to have an increase in eye pressure. Tell your healthcare provider if you have a
    history of glaucoma.
  • Melanoma. Studies of people with Parkinson’s disease show that they may be at an increased risk of developing melanoma, a form of
    skin cancer, when compared to people without Parkinson’s disease. It is not known if this problem is associated with Parkinson’s disease
    or the medicines used to treat Parkinson’s disease. RYTARY capsules are one of the medicines used to treat Parkinson’s disease.
    Therefore, you should be monitored for melanomas frequently and on a regular basis and have periodic skin examinations by an
    appropriately qualified individual.
  • Low blood pressure when you sit or stand up quickly. You may have dizziness, nausea, fainting, or sweating. Sit and stand up slowly
    after you have been sitting or lying down for a while.

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.

The most common adverse reactions reported by patients in clinical studies of RYTARY are nausea, dizziness, headache, sleeplessness,
abnormal dreams, dry mouth, abnormal involuntary movements, anxiety, constipation, vomiting and low blood pressure upon rising.

These are not all the possible side effects of RYTARY capsules. Call your healthcare provider for medical advice about side effects.

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.

Every Moment Counts.
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.

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.

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.

Reference:

1.RYTARY [package insert]. Hayward, CA: Impax Laboratories, Inc.; 2016.