Vyvanse Capsules

GENERIC NAME: LISDEXAMFETAMINE (lis-dex-am-FET-a-meen)

COMMON USES: This medicine is an amphetamine used to treat attention deficit disorder with hyperactivity (ADHD). It is used as a part of a total treatment program that may include psychological, educational, and social therapy. This medicine may also be used to treat other conditions as determined by your doctor.

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. TAKE THIS MEDICINE BY MOUTH in the morning with or without food. THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach. Swallow this medicine whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and dissolve the contents of the capsule in an 8oz (240 mL) glass of water. Drink the mixture right away. Do not store the mixture for future use. STORE THIS MEDICINE at room temperature 77 degrees F (25 degrees C), in a tightly-closed container, away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. 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 have had an allergic reaction to it, to sympathomimetic medicines (such as methylphenidate or pseudoephedrine), or if you are allergic to any ingredient in this product. IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. If using this medicine for an extended period of time, DO NOT SUDDENLY STOP taking this medicine without your doctor's approval. When used for an extended period of time, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming or cause other serious side effects. SERIOUS EFFECTS, INCLUDING HEART ATTACK, STROKE, AND SUDDEN DEATH, have occurred with the use of stimulant medicines 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. Laboratory and/or medical tests, including blood pressure and heart rate may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS, including corticosteroid levels. Make sure laboratory personnel and your doctors know you use this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. Amphetamines may affect growth rate in children and adolescents in some instances. Your child's growth should be checked regularly while using this medicine. This medicine may cause dizziness or blurred vision. DO NOT DRIVE, OPERATE MACHINERY, or do anything else that could be dangerous until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE MAY CAUSE SLEEPLESSNESS. Do not take this medicine near your bedtime unless your doctor tells you otherwise. AVOID LARGE AMOUNTS OF caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate. Caffeine can increase the side effects of this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN because they may be more sensitive to the effects of the medicine. FOR WOMEN: This medicine may cause harm to the fetus. IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include constipation; diarrhea; dizziness; dry mouth; headache; decreased appetite; nausea; increased sweating; mild irritability, nervousness, or restlessness; trouble sleeping; unpleasant taste; upper stomach pain; vomiting; and weight loss. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience unusual weakness or tiredness, or a change in sexual ability or desire. CONTACT YOUR DOCTOR IMMEDIATELY if you experience agitation; blurred vision or other vision changes; chest pain; fainting; fast or irregular heartbeat; fever; hallucinations; new or worsening mental or mood changes; seizures; severe or persistent headache; severe or persistent irritability, nervousness, or restlessness; shortness of breath; tremor; or uncontrolled speech or muscle movements (such as tics). An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. 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 HAS A HIGH RISK FOR ABUSE. It may be habit forming when used for a long period of time. Use this medicine only as prescribed. Do not share it with others. Abuse of this medicine may cause serious heart problems, blood vessel problems, or sudden death. 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 guanethidine or if you have taken furazolidone or a monoamine oxidase inhibitor (such as phenelzine) within the past 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking propoxyphene, tramadol, ammonium chloride, ascorbic acid (vitamin C), chlorpromazine, glutamic acid, haloperidol, lithium carbonate, methenamine, reserpine, sodium acid phosphate, acetazolamide, sodium bicarbonate, meperidine, norepinephrine, phenobarbital, phenytoin, selective serotonin reuptake inhibitors (SSRIs) (such as fluoxetine), tricyclic antidepressants (such as desipramine), antihistamines (such as diphenhydramine), sympathomimetics (such as pseudoephedrine), thiazide diuretics (such as indapamide), beta-blockers (such as atenolol), certain blood pressure medicines, or ethosuximide. INFORM YOUR DOCTOR if you have had an abnormal brain wave test (EEG) or if you have any other medical conditions including a history of seizures; stroke; growth problems; thyroid problems; liver or kidney problems; recent heart attack; heart defect or other heart problems (such as heart failure, heart rhythm problems); blood vessel problems; blood problems (such as porphyria); fast or irregular heartbeat; high blood pressure; alcohol or other substance abuse or dependence; allergies; pregnancy; or breast-feeding. INFORM YOUR DOCTOR if you have a family history of sudden death or heart rhythm problems. INFORM YOUR DOCTOR if you have a personal or family history of Tourette syndrome, uncontrolled muscle movements (such as tics), mental or mood problems, or suicidal thoughts or attempts. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have had an unusual reaction to a sympathomimetic medicine (such as methylphenidate, pseudoephedrine) including a fast or irregular heartbeat, overexcitement, or severe trouble sleeping. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have certain blood vessel problems (such as hardening of the arteries); heart problems; moderate, severe, or uncontrolled high blood pressure; high blood pressure in the lungs; anorexia; an overactive thyroid; increased pressure in the eye; glaucoma; serious heart defects; serious abnormal heart rhythm; an enlarged heart; agitation, anxiety, or tension; or a history of alcohol or other substance abuse. USE OF THIS MEDICINE IS NOT RECOMMENDED IN CHILDREN who are younger than 3 years old. 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.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe mental or mood changes; confusion; severe restlessness; fast breathing; hallucinations; irregular heartbeat; seizures; fever; severe or persistent headache, nausea, or diarrhea; or vomiting.

ADDITIONAL INFORMATION: IF YOU ARE TAKING THIS MEDICINE for ADHD or ADD and 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. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain a new prescription from your doctor before your supply runs out.

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.