Atomoxetine (a-toe-MOX-e-teen)

Treats attention-deficit/hyperactivity disorder (ADHD).

Brand Name(s):

Strattera

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
• For children or teenagers, the dose may need to be changed several times in order to find out what works best for them. Pay close attention to any changes in behavior that might happen.
• Swallow the capsule whole. Do not crush, break, chew, or open it.
• You may take this medicine with or without food.
• Avoid touching a broken or opened capsule. Wash your hands that touched an opened capsule with water immediately. If this medicine comes in contact with your eyes or your child's eyes, rinse it with water and call your doctor right away.
• This medicine is used as part of a treatment program that also includes social, educational, and psychologic treatment. Carefully follow your doctor's instructions about all treatment procedures.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

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

• Make sure your doctor knows if you are using dopamine (Intropin®), dobutamine (Dobutrex®), an asthma medicine (such as albuterol, Ventolin®), or a heart rhythm medicine (such as disopyramide, procainamide, quinidine, Norpace®, or Procanbid®). Tell your doctor if you are also using a medicine for depression such as fluoxetine, paroxetine, Luvox®, Paxil®, Prozac®, or Sarafem®.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, heart disease, blood vessel disease, heart rhythm problems, high or low blood pressure, or problems with urination. Tell your doctor if you have a genetic condition called CYP2D6 poor metabolizers or have a history of mental illness or bipolar disorder.
• This medicine may cause serious allergic reactions including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you take this medicine.
• Stop using this medicine and check with your doctor right away if you or your child get a skin rash, dark urine, persistent loss of appetite, yellow eyes or skin, flu-like symptoms or right upper belly pain or tenderness. These could be symptoms of a serious liver problem.
• This medicine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, shortness of breath, or fainting while taking this medicine.
• This medicine may make you or your child dizzy, drowsy, faint, or lightheaded. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.
• If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.
• This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.
• For some children and teenagers, this medicine can increase thoughts of suicide. All of the warnings in this leaflet are true for a child or teenager who is using this medicine. Tell your doctor right away if you start to feel more depressed. Also tell your doctor right away if you have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

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
• Chest pain or shortness of breath.
• Dark-colored urine or pale stools.
• Decrease in how much or how often you urinate.
• Fast, pounding, or uneven heartbeat.
• Flu-like symptoms.
• Headache, lightheadedness, dizziness, or fainting.
• Mood changes, aggressiveness, irritability, or depression.
• Nausea, vomiting, loss of appetite, constipation, upset stomach, or pain in your upper stomach.
• Painful, prolonged erection of the penis.
• Seeing, hearing, or feeling things that are not there.
• Seizures or tremors.
• Weight changes.
• Yellowing of your skin or the whites of your eyes.

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

• Changes in your menstrual cycle (periods), or menstrual cramps.
• Constipation, heartburn, stomach pain or upset.
• Dry mouth.
• Loss of interest in sex, or trouble having sex.
• Skin rash.
• Sleepiness or unusual drowsiness.
• Tiredness.
• Trouble sleeping.
• Warmth or redness in your face, neck, arms, or upper chest.

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