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IMPORTANT SAFETY INFORMATION ABOUT QELBREE

INDICATION

Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older.

IMPORTANT SAFETY INFORMATION ABOUT QELBREE
Qelbree may increase suicidal thoughts and actions, in adults and children with ADHD, especially within the first few months of treatment [read more] or when the dose is changed. Tell your doctor if you have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away.

IMPORTANT SAFETY INFORMATION ABOUT QELBREE
Qelbree may increase suicidal thoughts and actions, in adults and children with ADHD, especially within the first few months of treatment or when the dose is changed. [read more] Tell your doctor if you have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away.

You should not take Qelbree if you:
Take a medicine for depression called monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline.

Qelbree can increase blood pressure and heart rate. Your doctor will monitor these vital signs.

Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you show any signs of mania.

Do not drive or operate heavy machinery until you know how Qelbree will affect you. Qelbree may cause you to feel sleepy or tired.

The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree.

You may report negative side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see Medication Guide including Boxed Warning.

IMPORTANT SAFETY INFORMATION ABOUT QELBREE

INDICATION

Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older.

IMPORTANT SAFETY INFORMATION ABOUT QELBREE
Qelbree may increase suicidal thoughts and actions, in adults and children with ADHD, especially within the first few months of treatment [read more] or when the dose is changed. Tell your doctor if you have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away.

IMPORTANT SAFETY INFORMATION ABOUT QELBREE
Qelbree may increase suicidal thoughts and actions, in adults and children with ADHD, especially within the first few months of treatment or when the dose is changed. [read more] Tell your doctor if you have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away.

You should not take Qelbree if you:
Take a medicine for depression called monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline.

Qelbree can increase blood pressure and heart rate. Your doctor will monitor these vital signs.

Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you show any signs of mania.

Do not drive or operate heavy machinery until you know how Qelbree will affect you. Qelbree may cause you to feel sleepy or tired.

The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree.

You may report negative side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see Medication Guide including Boxed Warning.