This medicine is a central nervous system stimulant used to treat attention deficit hyperactivity disorder (ADHD). It may also be used to treat other conditions as determined by your doctor.
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. TAKE THIS MEDICINE by mouth in the morning. Talk with your doctor about how you should take this medicine in regard to food. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. If you cannot swallow this medicine whole, you may open the capsule and sprinkle the contents onto a spoonful of applesauce. Swallow immediately, followed by a glass of water. DO NOT use warm applesauce. Do not chew the applesauce mixture. Do not mix up a dose ahead of time for later use. IF YOU TAKE AN ANTACID, H2 antagonist (eg, ranitidine), or proton pump inhibitor (eg, omeprazole), ask your doctor or pharmacist how to take it with this medicine. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
WARNING: Use this medicine with caution if you have a history of mental or mood problems or alcohol or substance abuse or dependence. Abuse of this medicine may cause it to not work as well. Abuse may also lead to addiction and mental or mood changes. Do not suddenly stop using this medicine. Depression or other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it. 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 also taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), tricyclic antidepressants (eg, imipramine), or medicines for high blood pressure (eg, guanethidine, metoprolol). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of seizures or abnormal electroencephalograms (EEGs), overactive thyroid, chronic fatigue, cystic fibrosis, stomach or bowel problems (eg, blockage, inflammation, narrowing), allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of high blood pressure, blood vessel problems, heart problems (eg, heart failure, heart defects, fast or irregular heartbeat), or heart attack, or if a family member has a history of any of these problems or sudden death. Tell your doctor if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe anxiety, agitation, or tension; glaucoma; serious heart problems (eg, heart defect, irregular heartbeat); or motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome. Use of this medicine in CHILDREN under age 6 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include dizziness, drowsiness, dry mouth, headache, indigestion, loss of appetite, nausea, nervousness, stomach pain, stuffy nose, trouble sleeping, vomiting, or weight loss. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blurred vision or other vision changes; chest, jaw, or arm pain; confusion; dark urine; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; new or worsening mental, mood, or behavior changes (eg, abnormal thoughts, aggression, agitation, anxiety, depression, hostility, irritability, panic attacks, persistent crying, restlessness, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; sudden, severe nausea or vomiting; suicidal thoughts or attempts; tremors; uncontrolled muscle movements or speech; unusual sweating; unusual tiredness or weakness; or yellowing of the eyes or skin. 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; joint pain; purplish or brownish red spots on the skin; swelling of the mouth, face, lips, throat, or tongue; tightness in the chest, or difficulty breathing. 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.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include confusion, diarrhea, dry mouth, enlarged pupils, exaggerated reflexes, fainting, fast breathing, fast or irregular heartbeat, fever, flushing, hallucinations, loss of consciousness, mental or mood changes (eg, agitation, anxiety), muscle twitching, nausea, restlessness, seizures, severe or persistent dizziness or headache, tremors, unusual sweating, or vomiting.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. THIS MEDICINE CANNOT BE REFILLED. If you are using this medicine regularly, be sure to obtain a new prescription from your doctor before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.