What is the most important information I should know about lisdexamfetamine dimesylate capsules?
Lisdexamfetamine dimesylate capsules may cause serious side effects, including:

Your healthcare provider should check you or your child carefully for heart problems before starting treatment with lisdexamfetamine dimesylate capsules. Tell your healthcare provider if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with lisdexamfetamine dimesylate capsules.
Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with lisdexamfetamine dimesylate capsules.

 Tell your healthcare provider about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with lisdexamfetamine dimesylate capsules, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What are lisdexamfetamine dimesylate capsules?

Lisdexamfetamine dimesylate capsules are a central nervous system (CNS) stimulant prescription medicine used for the treatment of:

• Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years of age and older. Lisdexamfetamine dimesylate capsules may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
• Moderate to severe binge eating disorder (BED) in adults. Lisdexamfetamine dimesylate capsules may help reduce the number of binge eating days in people with BED.

• allergic to amphetamine products or any of the ingredients in lisdexamfetamine dimesylate capsules. See the end of this Medication Guide for a complete list of ingredients in lisdexamfetamine dimesylate capsules.
• taking, or have stopped taking in the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI).
• being treated with the antibiotic linezolid or intravenous methylene blue.

• have heart problems, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression or have a family history of suicide, bipolar illness, or depression
• have circulation problems in fingers and toes

• are breastfeeding or plan to breastfeed. Lisdexamfetamine dimesylate passes into breast milk. You should not breastfeed during treatment with lisdexamfetamine dimesylate. Talk to your healthcare provider about the best way to feed the baby during treatment with lisdexamfetamine dimesylate.

Tell your healthcare provider about all the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Lisdexamfetamine dimesylate capsules can affect the way other medicines work and other medicines may affect how lisdexamfetamine dimesylate capsules works. Taking lisdexamfetamine dimesylate capsules with other medicines can cause serious side effects. Sometimes the doses of other medicines will need to be changed while taking lisdexamfetamine dimesylate capsules.
Especially tell your healthcare provider if you or your child take:

Keep a list of all medicines to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if lisdexamfetamine dimesylate capsules can be taken with other medicines.

Do not start any new medicine during treatment with lisdexamfetamine dimesylate capsules without talking to your healthcare provider first.

How should lisdexamfetamine dimesylate capsules be taken?

• Take lisdexamfetamine dimesylate capsules exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose if needed.
• Take lisdexamfetamine dimesylate capsules 1 time each day in the morning with or without food.
• Your healthcare provider may sometimes stop lisdexamfetamine dimesylate capsules treatment for a while to check ADHD or BED symptoms.
• Lisdexamfetamine dimesylate comes in capsules or Vyvanse chewable tablets.

What are the possible side effects of lisdexamfetamine dimesylate capsules?
Lisdexamfetamine dimesylate capsules may cause serious side effects, including:

• See “What is the most important information I should know about lisdexamfetamine dimesylate capsules?”
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules treatment may be stopped if your child is not growing or gaining weight.

Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with lisdexamfetamine dimesylate capsules.

• Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome may happen when lisdexamfetamine dimesylate capsules is taken with certain other medicines. Stop taking lisdexamfetamine dimesylate capsules and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome:

The most common side effects of lisdexamfetamine dimesylate capsules in children 6 to 17 years old and adults with ADHD include:

The most common side effects of lisdexamfetamine dimesylate capsules in adults with BED include:

These are not all the possible side effects of lisdexamfetamine dimesylate capsules.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store lisdexamfetamine dimesylate capsules?

• Store lisdexamfetamine dimesylate capsules in a safe place (like a locked cabinet) and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect lisdexamfetamine dimesylate capsules from light.
• Dispose of remaining, unused, or expired lisdexamfetamine dimesylate capsules by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix lisdexamfetamine dimesylate capsules with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away (discard) lisdexamfetamine dimesylate capsules in the household trash.

Keep lisdexamfetamine dimesylate capsules and all medicines out of the reach of children.