Do not use atomoxetine if you have used an MAO inhibitor such as:

• isocarboxazid (Marplan®)
• tranylcypromine (Parnate®)
• phenelzine (Nardil®)
• rasagiline (Azilect®)
• selegiline (Eldepryl®, Emsam®)

within the past 14 days. Serious, life-threatening side effects can occur if you use atomoxetine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to atomoxetine, or if you have glaucoma. Some ADHD medicines have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Tell your doctor if you have any heart problems.

You may have suicidal thoughts or behavior while taking atomoxetine. Watch for symptoms of depression, unusual behavior, or thoughts of hurting yourself. Your doctor may need to check you at regular visits while you are taking this medication.

In addition to you watching for changes in your mood or behavior, your family or caregivers should be alert to changes in your mood or symptoms.

Do not use an open or broken capsule. If the medicine from inside the capsule gets into your eyes, rinse thoroughly with water and call your doctor. Atomoxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use this medication if you are allergic to atomoxetine or if you have glaucoma. Do not take atomoxetine if you have used an MAO inhibitor such as:

• isocarboxazid (Marplan®)
• tranylcypromine (Parnate®)
• phenelzine (Nardil®)
• rasagiline (Azilect®)
• selegiline (Eldepryl®, Emsam®)

within the past 14 days. Serious, life-threatening side effects can occur if you use atomoxetine before the MAO inhibitor has cleared from your body. Some ADHD medicines have caused sudden death in children and adolescents with serious heart problems or congenital heart defects.

Before using atomoxetine, tell your doctor if you are allergic to any drugs, or if you have:

• a congenital heart defect
• heart disease, a heart rhythm disorder, or recent heart attack
• coronary artery disease
• a history of stroke, blood clots, or heart attack
• high or low blood pressure
• liver disease
• problems with urination

• a personal or family history of:
• mental illness
• psychotic disorder
• bipolar illness
• depression
• suicide attempt

• if anyone in your family has died suddenly from a heart problem

If you have any of these conditions, you may not be able to use atomoxetine, or you may need a dosage adjustment or special tests during treatment.

You may have suicidal thoughts or behavior while taking atomoxetine. Watch for symptoms of depression, unusual behavior, or thoughts of hurting yourself. Your doctor may need to check you at regular visits while you are taking this medication.

In addition to you watching for changes in your mood or behavior, your family or caregivers should be alert to changes in your mood or symptoms.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether atomoxetine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Atomoxetine is not meant for long-term use. Because ADHD may be a long-term condition, especially in children and young adults, your doctor may recommend another ADHD medication after you stop taking atomoxetine.

Long-term use of atomoxetine can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly. Do not give atomoxetine to a child younger than 6 years old without the advice of a doctor.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Take this medicine with a full glass of water.

Atomoxetine is usually taken once daily, but it may be taken in the morning and late afternoon. Follow your doctor's instructions.

It is important to use atomoxetine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not use a capsule that has been opened or accidentally broken. The medicine from inside the capsule can be dangerous if it gets in your eyes. If you must handle a broken capsule, ask your doctor or pharmacist how to safely handle and dispose of the tablet. Store atomoxetine at room temperature away from moisture and heat.

Avoid using or handling an open or broken capsule. If the medicine from inside the capsule gets in your eyes, rinse them thoroughly with water and call your doctor. Atomoxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• Hives
• Difficulty breathing
• Swelling of your face, lips, tongue, or throat

Seek medical attention right away if any of these SEVERE side effects occur:

• chest pain, shortness of breath, fast or uneven heartbeats
• feeling light-headed or fainting
• unusual thoughts or behavior, aggression, hallucinations (seeing things that are not there)
• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure)
• urinating less than usual or not at all

Continue taking atomoxetine and talk to your doctor if you have any of these less serious side effects:

• feeling irritable
• feeling dizzy or drowsy
• nausea, vomiting, stomach pain, loss of appetite, constipation
• cough, dry mouth
• skin rash or itching
• sleep problems (insomnia)
• increased menstrual cramps
• impotence, loss of interest in sex, or trouble having an orgasm

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

Before taking atomoxetine, tell your doctor if you are using any of the following drugs:

• albuterol (Proventil®, Ventolin®)
• amiodarone (Cordarone®, Pacerone®)
• bupropion (Wellbutrin®, Zyban®)
• celecoxib (Celebrex®)
• cimetidine (Tagamet®)
• doxorubicin (Adriamycin®)
• methadone (Dolophine®, Methadose®)
• metoclopramide (Reglan®)
• quinidine (Cardioquin®, Quinaglute®, Quinidex®)
• ritonavir (Norvir®)
• ranitidine (Zantac®)
• terbinafine (Lamisil®)

• antidepressants such as:
• citalopram (Celexa®)
• clomipramine (Anafranil®)
• escitalopram (Lexapro®)
• fluoxetine (Prozac®, Sarafem®)
• fluvoxamine (Luvox®)
• paroxetine (Paxil®)
• sertraline (Zoloft®)

• antihistamines or sleep medicine such as:
• diphenhydramine (Benadryl®, Unisom®, and others)
• chlorpheniramine (Chlor-Trimeton® and others)

If you are using any of these drugs, you may not be able to use atomoxetine, or you may need dosage adjustments or special tests during treatment.

This may not be a complete list of all interactions that may occur. There may be other drugs not listed that can affect atomoxetine. Check with your health care provider before you start, stop, or change the dose of any medicine.