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How should this medicine be used?

Lisdexamfetamine comes as a capsule to be taken by mouth. It is usually taken once a day in the morning with or without food. Take lisdexamfetamine at around the same time every day. Do not take lisdexamfetamine in the late afternoon or evening because it may cause difficulty falling asleep or staying asleep. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lisdexamfetamine exactly as directed.

You may swallow the capsule whole, or you may open the capsule, sprinkle the entire contents into a glass of water, and stir to dissolve. Drink the mixture right away. Do not store the mixture for future use, and do not divide the contents of one capsule into more than one dose.

Your doctor will probably start you on a low dose of lisdexamfetamine and increase your dose gradually, not more often than once every week.Your doctor may decrease your dose if you experience unpleasant side effects.

Your doctor may tell you to stop taking lisdexamfetamine from time to time to see if the medication is still needed. Follow these directions carefully.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• restlessness

• confusion

• aggressive behavior

• feelings of panic

• hallucination (seeing things or hearing voices that do not exist)

• fast breathing

• uncontrollable shaking of a part of the body

• fever

• muscle weakness or aching

• tiredness or weakness

• depression

• fast or irregular heartbeat

• nausea

• vomiting

• diarrhea

• stomach cramps

• seizures

• coma (loss of consciousness for a period of time)

What special precautions should I follow?

Before taking lisdexamfetamine,

• tell your doctor and pharmacist if you are allergic to lisdexamfetamine; other stimulant medications such as amphetamine (in Adderall), benzphetamine (Didrex), dextroamphetamine (in Adderall, Dexedrine, Dextrostat), methamphetamine (Desoxyn); any other medications, or any of the ingredients in lisdexamfetamine capsules. Ask your doctor or pharmacist or check the manufacturer's information for a list of the ingredients.

• tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking one of these medications during the past 14 days. Your doctor will probably tell you not to take lisdexamfetamine until at least 14 days have passed since you last took an MAO inhibitor.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), and terazosin (Hytrin); antidepressants ('mood elevators') such as desipramine and protriptyline; antihistamines (medications for colds and allergies); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); diuretics ('water pills') such as acetazolamide (Diamox); lithium (Lithobid, Eskalith); narcotic medications for pain; other medications for ADHD; medications for asthma, colds, and high blood pressure; medications for mental illness such as chlorpromazine (Thorazine) and haloperidol (Haldol); certain medications for seizures such as ethosuximide (Zarontin), phenobarbital, and phenytoin (Dilantin); meperidine (Demerol); methenamine (Hiprex, Urex); propoxyphene (Darvon, Darvon-N); and sodium phosphate (OsmoPrep, Visicol). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had glaucoma (increased pressure in the eye that may cause vision loss), hyperthyroidism (condition in which there is too much thyroid hormone in the body), or feelings of anxiety, tension, or agitation. Your doctor will probably tell you not to take lisdexamfetamine.

• tell your doctor if anyone in your family has or has ever had an irregular heartbeat or has died suddenly. Also tell your doctor if you have recently had a heart attack and if you have or have ever had a heart defect, high blood pressure, an irregular heartbeat, hardening of the arteries, or other heart problems. Your doctor will examine you to see if your heart and blood vessels are healthy before you start taking lisdexamfetamine and will check your heart and blood pressure regularly during your treatment with lisdexamfetamine. Your doctor will probably tell you not to take lisdexamfetamine if you have a heart condition or if there is a high risk that you may develop a heart condition.

• tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), motor tics (repeated uncontrollable movements), verbal tics (repetition of sounds or words that is hard to control), or Tourette's syndrome (a condition characterized by the need to perform repeated motions or to repeat sounds or words), or has thought about or attempted suicide Also tell your doctor if you have or have ever had mental illness, seizures, an abnormal electroencephalogram (EEG; a test that measures electrical activity in the brain), or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking lisdexamfetamine, call your doctor.

• talk to your doctor about the risks and benefits of taking lisdexamfetamine if you are 65 years of age or older. Older adults should not usually take lisdexamfetamine because it is not as safe as other medications that can be used to treat the same condition.

• you should know that this medication may make it difficult for you to perform activities that require alertness or physical coordination. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that lisdexamfetamine should be used as part of a total treatment program for ADHD, which may include counseling and special education. Make sure to follow all of your doctor's and/or therapist's instructions.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What side effects can this medication cause?

Lisdexamfetamine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• difficulty falling asleep or staying asleep

• sleepiness

• uncontrollable shaking of a part of the body

• dizziness

• jitters

• headache

• dry mouth

• stomach pain

• diarrhea

• nausea

• vomiting

• loss of appetite

• weight loss

• fever

• sweating

• fast or pounding heartbeat

• chest pain

• shortness of breath

• fainting

• slow or difficult speech

• weakness or numbness of an arm or leg

• seizures

• hallucinating (seeing things or hearing voices that do not exist)

• believing things that are not true

• feeling unusually suspicious of others

• aggression

• irritability

• mood swings

• frenzied, abnormally excited mood

• tics

• hives

• rash

• swelling of the eyes, face, tongue, lips, or mouth

• blurred vision or other vision problems

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• difficulty falling asleep or staying asleep

• sleepiness

• uncontrollable shaking of a part of the body

• dizziness

• jitters

• headache

• dry mouth

• stomach pain

• diarrhea

• nausea

• vomiting

• loss of appetite

• weight loss

• fever

• sweating

• fast or pounding heartbeat

• chest pain

• shortness of breath

• fainting

• slow or difficult speech

• weakness or numbness of an arm or leg

• seizures

• hallucinating (seeing things or hearing voices that do not exist)

• believing things that are not true

• feeling unusually suspicious of others

• aggression

• irritability

• mood swings

• frenzied, abnormally excited mood

• tics

• hives

• rash

• swelling of the eyes, face, tongue, lips, or mouth

• blurred vision or other vision problems

Lisdexamfetamine may cause sudden death in children and teenagers, especially children and teenagers who have heart defects or serious heart problems. This medication also may cause sudden death, heart attack or stroke in adults, especially adults who have heart defects or serious heart problems. Talk to your doctor about the risks of taking this medication.

Lisdexamfetamine may slow children's growth or weight gain. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is taking this medication. Talk to your child's doctor about the risks of giving lisdexamfetamine to your child.

Lisdexamfetamine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to lisdexamfetamine.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking lisdexamfetamine.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

• Vyvanse