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

Treats attention-deficit/hyperactivity disorder (ADHD) and binge eating disorder.

Brand Name(s):

Vyvanse

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Chewable Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine in the morning. It may be hard for you to sleep if you take it in the afternoon or evening.
• Capsule:
  • Swallow whole. Do not crush, divide, or chew it.
  • If you cannot swallow the capsule, you may open the capsule and mix the powder with water, yogurt, or orange juice. Use all of the powder from inside the capsule. Use a spoon to break up any clumps of powder. Eat or drink all of this mixture right away. Do not save any for later.
• Chewable tablet: Chew thoroughly before swallowing.
• You may substitute Vyvanse® capsules with Vyvanse® chewable tablets with the same dosage strength. Do not take anything less than 1 capsule or chewable tablet per day.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how lisdexamfetamine works. Tell your doctor if you are using any of the following:
  • Acetazolamide, ammonium chloride, ascorbic acid, buspirone, fentanyl, hydrochlorothiazide, lithium, methenamine salts, quinidine, ritonavir, sodium acid phosphate, sodium bicarbonate, St John's wort, tramadol
  • Medicine to treat depression (including desipramine, fluoxetine, paroxetine, protriptyline)
  • Triptan medicine to treat migraine headaches
  • Tryptophan supplement
  .

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, heart disease, heart rhythm problems, high blood pressure, blood circulation problems, Tourette syndrome, or a history of heart attack or stroke. Tell your doctor if you or anyone in your family has a history of depression, bipolar disorder, suicide, or mental health problems, or you have a history of drug or alcohol addiction.
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • Serious heart or blood vessel problems, including heart attack or stroke
  • Unusual changes in mood or behavior
  • Slow growth in children
  • Raynaud phenomenon (problem with the blood circulation in your fingers or toes)
  • Serotonin syndrome (when used with certain medicines)
  • Onset or worsening of motor or verbal tics (including Tourette syndrome)
• This medicine may make you dizzy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Anxiety, restlessness, fever, muscle spasms, twitching, nausea, vomiting, diarrhea
• Blistering, peeling, red skin rash
• Blurred vision, lightheadedness or fainting, muscle cramps, seeing, hearing, or feeling things that are not there, sweating, trouble breathing
• Chest pain that may spread, fast, pounding, or uneven heartbeat
• Extreme energy, mood or mental changes, confusion, agitation, trouble sleeping, unusual behavior
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Sores, coldness, numbness, or color changes on your fingers or toes

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

• Dry mouth
• Loss of appetite, weight loss (in children), stomach pain

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