Lisdexamfetamine dimesylate (By mouth)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding or if you have heart or heart rhythm problems, a recent heart attack, high blood pressure, or thyroid problems. Tell your doctor if you have muscle or vocal tics or Tourette syndrome.
• Your doctor should know if you have epilepsy or a history of seizures, depression, mental illness, or bipolar disorder. Tell your doctor if you have any drug or alcohol problems. Also tell your doctor if you or anyone in your family has tried to commit suicide.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• Check with your doctor right away if you have chest pain, trouble breathing, or fainting while taking this medicine. This medicine can cause serious heart or blood vessel problems.
• Tell your doctor right away if you or anyone in your family notices any unusual changes in behavior, such as an increase in aggression, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you have hallucinations or any unusual thoughts, especially if these are new or get worse quickly.
• This medicine may cause slow growth in children. The doctor will need to keep track of your child's height and weight to make sure your child is growing properly.
• This medicine may cause blurred vision or make you drowsy or dizzy. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.Your doctor will need to check your blood, heart, and blood pressure for side effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Changes in your vision
• Chest pain, trouble breathing, or fainting
• Fast, pounding, or uneven heartbeat
• Mood changes or unusual or disturbing thoughts
• Numbness or weakness in your arm, leg, or on one side of your body
• Seeing, hearing, or feeling things that are not there
• Seizures
• Uncontrollable body movements or twitching

If you notice these less serious side effects, talk with your doctor:

• Dizziness
• Dry mouth
• Feeling restless, irritable, or nervous
• Loss of appetite or weight loss
• Mild skin rash
• Nausea, vomiting, diarrhea, or stomach pain
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

When This Medicine Should Not Be Used

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use blood pressure medicines (such as atenolol, lisinopril, metoprolol, Cozaar®, or Diovan®), a diuretic or "water pill" (such as hydrochlorothiazide), certain pain medicines (such as meperidine, propoxyphene, Demerol®, or Darvon®), acetazolamide (Diamox®), ammonium chloride, chlorpromazine (Thorazine®), cold or allergy medicines, ethosuximide (Zarontin®), guanfacine (Tenex®), haloperidol (Haldol®), lithium carbonate (Lithobid®), certain medicines for depression (such as amitriptyline, doxepin, nortriptyline, Pamelor®, or Sinequan®), methenamine (Hiprex, Urex®), norepinephrine, phenobarbital (Luminal®), phenytoin (Dilantin®), sodium acid phosphate, or veratrum alkaloids.

Introduction

Lisdexamfetamine Dimesylate (lis-dex-am-FET-a-meen dye-MES-i-late)

Treats attention deficit hyperactivity disorder (ADHD). This medicine is a stimulant.

Brand Name(s)

Vyvanse

How to Use This Medicine

Capsule

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• It is best to take this medicine in the morning. This medicine could make it harder for you to fall asleep if you take it in the afternoon or evening.
• Swallow the capsule whole. If you cannot swallow the capsule whole, you may open it and pour the medicine into a glass of water. Stir this mixture well and drink it right away.
• This medicine is part of an ADHD treatment program that may also include counseling or special education. Carefully follow your doctor's instructions about all treatment measures.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.