Lisdexamfetamine dimesylate (By mouth)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you or your child have heart problems, thyroid problems, or mild high blood pressure. Tell your doctor if you or your child have muscle tics or Tourette's syndrome, a condition that causes you to have muscle twitches or to make sounds you are not able to control.
• Your doctor should know if you or your child have epilepsy, or a history of seizures, depression, mental illness, or bipolar disorder. Tell your doctor about 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.
• This medicine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, shortness of breath, or fainting while taking this medicine.
• Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.
• This medicine may cause slow growth. If your child is using this medicine, 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. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well.
• 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 or your child's blood, heart, and blood pressure for any problems or unwanted effects that may be caused by this medicine.

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.
• Blurred vision or trouble seeing.
• Chest pain, shortness of breath, or fainting.
• Fast, pounding, or uneven heartbeat.
• Mood or mental changes, or unusual or disturbing thoughts.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Seeing, hearing, or feeling things that are not there.
• Seizures.
• Tremors or shaking.
• Uncontrollable muscle movements or twitching.

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

• Constipation, diarrhea, or upset stomach.
• Dry mouth or bad taste in your mouth.
• Feeling restless, irritable, or nervous.
• Headache or dizziness.
• Loss of appetite or weight loss.
• Mild skin rash.
• Nausea, vomiting, or stomach pain.
• Problems having sex.
• 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

You should not use this medicine if you or your child have had an allergic reaction to lisdexamfetamine dimesylate. You should not use this medicine if you have glaucoma, an overactive thyroid, high blood pressure, heart disease, heart rhythm problems (such as ventricular arrhythmia), blood vessel problems (such as hardening of the arteries), or a recent heart attack or stroke. Do not use this medicine if you have a history of drug abuse, or if you are very nervous, tense, or agitated most of the time. You should not use this medicine if you have used a drug for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days. Do not give this medicine to a child younger than 6 years of age.

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 are also using blood pressure medicines (such as atenolol, lisinopril, metoprolol, Cozaar®, or Diovan®), a diuretic or "water pill" (such as hydrochlorothiazide [HCTZ]), 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, 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

There may be other brand names for this medicine.

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.
• You may take this medicine with or without food.
• It is best to take this medicine in the morning. Taking this medicine in the afternoon or evening could make it harder for you to fall asleep.
• 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 swallow 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.