Qelbree contains the active ingredient viloxazine in the form of viloxazine hydrochloride, which acts as a selective norepinephrine reuptake inhibitor. It is formulated as extended-release capsules for oral administration, available in strengths of 100 mg, 150 mg, and 200 mg of viloxazine free base (equivalent to 115 mg, 173 mg, and 231 mg of viloxazine hydrochloride salt, respectively). Key inactive ingredients include ammonium hydroxide, corn starch, and lactose monohydrate, among others.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush, or chew this medication. Swallow the capsules whole. You may open the capsule and put the contents in 1 teaspoon of applesauce. Swallow the medication and applesauce right away or within 2 hours of mixing. Do not chew the medication or applesauce. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Fast or irregular heartbeat -Increase in blood pressure -Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Drowsiness -Fatigue -Irritability -Loss of appetite -Nausea -Trouble sleeping -Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Depression -High blood pressure -Irregular heartbeat or other heart disease -Kidney disease -Liver disease -Mania or bipolar disorder -Other mental health condition -Suicidal thoughts, plans, or attempt by you or a family member -Taken an MAOI, such as isocarboxazid, phenelzine, rasagiline, safinamide, selegiline, or tranylcypromine, in the last 14 days -An unusual or allergic reaction to viloxazine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Alosetron -Duloxetine -MAOIs, such as isocarboxazid, phenelzine, rasagiline, safinamide, selegiline, tranylcypromine -Ramelteon -Tasimelteon -Theophylline or aminophylline -Thioridazine -Tizanidine This medication may also interact with the following: -Atomoxetine -Certain medications for depression, anxiety, or mental health conditions -Clozapine -Melatonin -Pirfenidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your care team right away. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce dizzy or fainting spells. Drinking alcohol with this medication can increase your risk of these side effects. Decreased appetite is a common side effect when starting this medication. Eating small, frequent meals or snacks can help. Talk to your care team if you continue to have poor eating habits. This medication may slow your child's growth if it is taken for a long time at high doses. Your care team will monitor your child's growth.

What are the most serious risks of this medication?

This medication may increase thoughts of suicide. This may be more common in children, teenagers, and young adults. The risk may increase after first starting the medication and after dose changes. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide.