Strattera 10 mg Capsules

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does NOT assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ATOMOXETINE - ORAL

(A-toe-MOX-e-teen)

COMMON BRAND NAME(S): Strattera

WARNING: Studies have shown that a small number of people (especially children/teenagers) who take atomoxetine for attention-deficit hyperactivity disorder (ADHD) may experience worsening of their condition, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of this medication (especially for children/teenagers). Tell the doctor immediately if you notice worsening of your condition/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, hallucinations, delusions, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when you first start this medication or when the dose is changed.

USES: Atomoxetine is used to treat attention-deficit hyperactivity disorder (ADHD). It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters). It may help to increase the ability to pay attention, concentrate, stay focused, and stop fidgeting.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using atomoxetine and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. This medication may be taken with or without food. Take this medication as prescribed, usually either as a single daily dose in the morning or divided into two doses in the morning and late afternoon/early evening; or as directed by your doctor. Swallow the capsules whole. Do not crush, chew, or open the capsules. The powder in the capsules can irritate the eyes. Wash your hands and any surface that comes in contact with the powder. If the powder gets in your eyes, flush with plenty of water and contact your doctor right away. Your dosage is based on your medical condition and response to therapy. Do not increase your dose or take it more frequently than prescribed. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. Inform your doctor if your symptoms persist or worsen.

SIDE EFFECTS: See also Warning section. Stomach upset, nausea, vomiting, constipation, fatigue, loss of appetite, headache, dry mouth, dizziness, drowsiness, trouble sleeping, menstrual cycle changes, or mood changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: weight loss, decrease in sexual ability/desire (e.g., impotence, ejaculation problems), difficulty urinating, unusually fast/irregular heartbeat, fainting, numbness/tingling. This medication may rarely cause serious problems such as heart attacks or stroke. Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision). Atomoxetine has very rarely caused very serious liver problems. If you notice any of the following highly unlikely but very serious side effects, seek immediate medical attention: yellowing of skin or eyes, dark urine, severe stomach pain, "flu-like" symptoms (e.g., fever, chills, unexplained fatigue). If you experience any of these symptoms ask your doctor about whether or not you should ever take atomoxetine again. Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, seek immediate medical attention, or permanent problems could occur. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the U.S. - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking atomoxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow angle). Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, heart disease (e.g., high blood pressure, fast/irregular heartbeat or long QT syndrome, cardiomyopathy, structural heart abnormalities, past heart attacks), family history of irregular heartbeat (cardiac sudden death, QT prolongation in the EKG), low blood pressure, strokes, bladder or prostate problems, certain adrenal problem (pheochromocytoma), mental/mood disorders (such as bipolar disorder, depression, suicide attempts, family history of suicide). This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. To minimize dizziness or fainting, get up slowly from a lying or seated position (especially when you first start using this drug or if your doctor changes your dose). Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially dizziness. Caution is advised when using this drug in children because it may have a minor effect on weight, growth rate, and final height. Monitor your child's weight and height and consult your doctor or pharmacist for more details. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: asthma drugs (e.g., albuterol, metaproterenol), fluoxetine, paroxetine, quinidine. Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: unusually fast heartbeat, severe headache.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., pulse and blood pressure, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. If you have heart disease, your doctor should perform certain heart tests (EKG, echocardiogram) before you start taking atomoxetine. Keep all medical appointments with your doctor.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised June 2012. Copyright(c) 2012 First Databank, Inc.