Viloxazine (vye-LOX-a-zeen)

Treats attention deficit hyperactivity disorder (ADHD).

Brand Name(s):

Qelbree

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Do not cut, crush, or chew the capsule. You may swallow the capsule whole, or open it and sprinkle the contents over a teaspoonful of applesauce or pudding. Swallow the mixture right away, within 2 hours of mixing for applesauce, or within 15 minutes of mixing for pudding. Do not chew the mixture or store it for future use.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) within the past 14 days.
• Do not use this medicine if you are using alosetron, duloxetine, ramelteon, tasimelteon, theophylline, or tizanidine.
• Some medicines can affect how viloxazine works. Tell your doctor if you are using alfentanil, atomoxetine, avanafil, buspirone, clozapine, conivaptan, darifenacin, darunavir, desipramine, dextromethorphan, ebastine, everolimus, ibrutinib, lomitapide, lovastatin, lurasidone, metoprolol, midazolam, naloxegol, nebivolol, nisoldipine, nortriptyline, perphenazine, pirfenidone, risperidone, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir, tolterodine, triazolam, vardenafil, or venlafaxine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, heart disease, heart rhythm problems, or high blood pressure. Tell your doctor if you or anyone in your family has a history of depression, bipolar disorder, suicide, or mental illness.
• This medicine may cause the following problems:
  • Unusual thoughts or behavior, including thoughts of suicide
  • High blood pressure
• This medicine may make you drowsy, sleepy, or tired. Do not drive or doing anything that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Extreme energy, mood or mental changes, confusion, anxiety, agitation, restlessness, trouble sleeping, unusual thoughts or behavior
• Fast, slow, pounding, or uneven heartbeat
• Sleepiness, unusual drowsiness, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite, nausea, vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088