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What is INTUNIV?

INTUNIV is a prescription medicine used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 to 17. INTUNIV may be used alone or added to an ADHD stimulant medicine. INTUNIV was shown to work in clinical studies lasting up to 8 weeks.

Important Safety Information About INTUNIV

Patients should not take INTUNIV if they are allergic to guanfacine or other ingredients in INTUNIV, or other medicines containing guanfacine. Tell the doctor about all medicines, vitamins, and herbal supplements your child is taking.

INTUNIV may cause serious side effects including low blood pressure, low heart rate, fainting, and sleepiness.

Before starting INTUNIV, tell the doctor if your child has low blood pressure, low heart rate, heart problems, has fainted, has liver or kidney problems, or has any other medical condition. You should also tell the doctor if your child is pregnant, breast-feeding, or plans to become pregnant or breast-feed.

Patients should drink plenty of water and not get overheated while taking INTUNIV.

Patients should not drive or use machinery like lawn mowers or power tools until they know how INTUNIV affects them. INTUNIV can slow thinking and motor skills. While taking INTUNIV, patients should not drink alcohol or take other medicines that can cause sleepiness or dizziness because these symptoms may get worse.

The most common side effects of INTUNIV include sleepiness, tiredness, trouble sleeping, low blood pressure, nausea, stomach pain, and dizziness.

INTUNIV should be swallowed whole without crushing, chewing, or breaking the tablet. INTUNIV should not be taken with a high-fat meal. Do not change the dose or stop INTUNIV without talking with the doctor. The doctor will regularly check your child's blood pressure and heart rate.

Please see Full Prescribing Information, including Patient 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.

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