Strattera Capsules

GENERIC NAME: ATOMOXETINE (A-toe-MOX-e-teen)

COMMON USES: This medicine is a selective norepinephrine reuptake inhibitor used to treat attention deficit hyperactivity disorder (ADHD). This medicine increases certain chemicals (eg, norepinephrine) in the brain. This may affect attention span and behavior.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. SWALLOW THIS MEDICINE WHOLE. Do not break, crush, or chew before swallowing. DO NOT OPEN the capsules or take them apart. If a capsule breaks, do not touch it. Wash your hands and any surfaces that touched a broken capsule. AVOID GETTING THIS MEDICINE IN YOUR EYES or on the inside of your nose. If you get it in your eyes or nose, rinse at once with cool water. TAKE THIS MEDICINE by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. DO NOT TAKE MORE THAN THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. STORE THIS MEDICINE at room temperature at 77 degrees F (25 degrees C), away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. Taking this medicine at the same time each day will help you to remember. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

CAUTIONS: DO NOT TAKE THIS MEDICINE if you are allergic to any ingredient in this medicine. THIS MEDICINE MAY INCREASE THE RISK OF SUICIDAL THOUGHTS OR ACTIONS IN CHILDREN AND TEENAGERS. ADULTS MAY ALSO BE AFFECTED. The risk may be greater in patients with a history of suicidal thoughts or actions, bipolar (manic-depressive) illness, or in patients with a family member with bipolar disorder. WATCH PATIENTS WHO TAKE THIS MEDICINE CLOSELY, especially during the first few months of taking this medicine and at times of dose changes. CONTACT THE DOCTOR AT ONCE IF new, worsened, or sudden symptoms such as depressed mood; agitation; aggressive, anxious, hostile, impulsive, manic, restless, or irritable behavior; panic attacks; trouble sleeping; or any unusual change in mood or behavior occur. CONTACT THE DOCTOR RIGHT AWAY IF ANY SIGNS OF SUICIDAL THOUGHTS or actions occur. THIS MEDICINE SHOULD BE USED AS PART OF A COMPLETE TREATMENT PROGRAM. Be sure to follow the program given to you by your doctor or health care provider. LAB TESTS, including liver function, blood pressure, and heart rate, may be performed to monitor your condition or to check for side effects. Be sure to keep all doctor and lab appointments. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you take this medicine. THIS MEDICINE MAY CAUSE DIZZINESS, DROWSINESS, LIGHTHEADEDNESS, OR FAINTING; alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. These effects may be worse if you take this medicine with alcohol or certain medicines. DO NOT DRIVE OR PERFORM OTHER POSSIBLY UNSAFE TASKS until you know how you react to it. SERIOUS EFFECTS, including heart attack, stroke, and sudden death, have occurred with the use of this medicine in patients with heart defects or other serious heart problems. If you have a heart defect or other serious problem, talk with your doctor about other therapies to treat your condition. THIS MEDICINE MAY RARELY CAUSE A PROLONGED, PAINFUL ERECTION. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. Use this medicine with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness. THIS MEDICINE MAY AFFECT GROWTH RATE IN CHILDREN and teenagers in some cases. They may need regular growth checks while they take this medicine. FOR WOMEN: IF YOU BECOME PREGNANT, discuss with your doctor the benefits and risks of taking this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS FOUND in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you take this medicine, check with your doctor. Discuss any possible risks to your baby.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include constipation, coughing, decreased appetite, decreased sexual desire, dizziness, drowsiness, dry mouth, fatigue, flushing, headache, increased sweating, nausea, mild stomach pain or upset, tiredness, trouble sleeping, and vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thoughts or elevated mood (mania); change in feeling of touch or other senses (eg, smell, taste); chest pain; confusion; decreased or difficult urination; decreased sexual ability (eg, impotence, ejaculation problems); fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; menstrual cycle changes; mental or mood changes (eg, agitation, anxiety, depression, irritability, persistent crying, unusual sadness); new or worsening behavior changes (eg, aggression, hostility, impulsiveness, restlessness); numbness or tingling; one-sided weakness; panic attacks; prolonged or painful erection; seizure; severe or persistent headache or dizziness; severe or persistent trouble sleeping, fatigue, or tiredness; shortness of breath; stomach pain or tenderness; suicidal thoughts or attempts; symptoms of liver damage (eg, yellowing of the skin or eyes, itching, dark urine, pale stools, loss of appetite, right upper stomach pain, unexplained flu-like symptoms); tics; unusual vision or speech changes; or unusually cold or blue fingers or toes. AN ALLERGIC REACTION TO THIS MEDICINE is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: WARNING: THIS MEDICINE MAY INCREASE THE RISK OF SUICIDAL THOUGHTS OR ACTIONS IN CHILDREN AND TEENAGERS WITH ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD). Be sure that the benefits of using this medicine outweigh the risks. Talk with the patient's doctor if you have any questions. Family and caregivers must closely observe patients who take this medicine. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms such as worsened depression, suicidal thoughts, or changes in behavior. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are currently taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), albuterol, a decongestant (eg, pseudoephedrine, phenylephrine), or medicine for high blood pressure. DO NOT START OR STOP ANY MEDICINE without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including liver problems, Raynaud syndrome, trouble urinating, a history of seizures, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a personal or family history of blood or bleeding problems, a stroke or bleeding in the brain, heart problems (eg, heart failure; fast, slow, or irregular heartbeat), heart attack, an abnormal electrocardiogram (ECG), high or low blood pressure, bipolar disorder (manic depression) or other mood or mental problems (eg, agitation, anxiety, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence. Tell your doctor if you have a family history of sudden death. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have certain heart problems (eg, heart defect, heart muscle problems), certain types of irregular heartbeat, severe blood vessel problems, or narrow-angle glaucoma. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have or have a history of a certain type of adrenal gland tumor (pheochromocytoma). Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

OVERDOSE: IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include abnormal behavior; agitation; enlarged pupils; fast or irregular heartbeat; hyperactivity; mental changes (eg, disorientation, hallucinations); nausea, vomiting, or diarrhea; seizures; severe dizziness, sleepiness, or drowsiness; severe dry mouth; severe or persistent headache; or tremor.

ADDITIONAL INFORMATION: If your symptoms do not improve or if they become worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine. The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.