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 like symptoms that may result from carbon monoxide or manganese poisoning.

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 and also have irregular heartbeats. 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 a peptic 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.

Following use in the marketplace, 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.

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.

Adverse events following unintentional overdose with this medication have been reported. If you accidentally take more than your prescribed dose, talk to your healthcare provider right away.

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

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the full Prescribing Information. For more information, talk to your healthcare provider.