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

• Abuse and dependence. Lisdexamfetamine dimesylate chewable tablets, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and may cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with lisdexamfetamine dimesylate chewable tablets.
  o Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  o Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
• Heart-related problems including:
  o sudden death, stroke, and heart attack in adults
  o sudden death in children who have heart problems or heart defects
  o increased blood pressure and heart rate
  Your healthcare provider should check you or your child carefully for heart problems before starting treatment with lisdexamfetamine dimesylate chewable tablets. 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 chewable tablets.
  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 chewable tablets.
• Mental (psychiatric) problems, including:
  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
  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 chewable tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What are lisdexamfetamine dimesylate chewable tablets?

Lisdexamfetamine dimesylate chewable tablets 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 chewable tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
• Moderate to severe binge eating disorder (BED) in adults. Lisdexamfetamine dimesylate chewable tablets may help reduce the number of binge eating days in people with BED.

Lisdexamfetamine dimesylate chewable tablets are not for use in children under 6 years of age with ADHD.

Lisdexamfetamine dimesylate chewable tablets are not for weight loss. It is not known if lisdexamfetamine dimesylate chewable tablets are safe and effective for the treatment of obesity.
It is not known if lisdexamfetamine dimesylate chewable tablets are safe and effective for use in children with BED.
Lisdexamfetamine dimesylate chewable tablets are a federally controlled substance (CII) because it contains lisdexamfetamine dimesylate that can be a target for people who abuse prescription medicines or street drugs. Keep lisdexamfetamine dimesylate chewable tablets in a safe place to protect it from theft. Never give your lisdexamfetamine dimesylate chewable tablets to anyone else because it may cause death or harm them. Selling or giving away lisdexamfetamine dimesylate chewable tablets may harm others and is against the law.

Do not take lisdexamfetamine dimesylate chewable tablets if you or your child are:

• allergic to amphetamine products or any of the ingredients in lisdexamfetamine dimesylate chewable tablets. See the end of this Medication Guide for a complete list of ingredients in lisdexamfetamine dimesylate chewable tablets.
• 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.

Before taking lisdexamfetamine dimesylate chewable tablets, tell your healthcare provider about all medical conditions, including if you or your child:

• 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 pregnant or plan to become pregnant. Lisdexamfetamine dimesylate may harm the unborn baby.
  o There is a pregnancy registry for females who are exposed to lisdexamfetamine dimesylate during pregnancy. The purpose of the registry is to collect information about the health of females exposed to lisdexamfetamine dimesylate and their baby. If you or your child becomes pregnant during treatment with lisdexamfetamine dimesylate, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/adhd-medications/.
• 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 chewable tablets can affect the way other medicines work and other medicines may affect how lisdexamfetamine dimesylate chewable tablets works. Taking lisdexamfetamine dimesylate chewable tablets with other medicines can cause serious side effects. Sometimes the doses of other medicines will need to be changed while taking lisdexamfetamine dimesylate chewable tablets.

Especially tell your healthcare provider if you or your child take:

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

How should lisdexamfetamine dimesylate chewable tablets be taken?

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

• Chew lisdexamfetamine dimesylate chewable tablets completely before swallowing.

What should I avoid while taking lisdexamfetamine dimesylate chewable tablets?

Do not drive, operate machinery, or do other dangerous activities until you know how lisdexamfetamine dimesylate chewable tablets affects you.

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

• See "What is the most important information I should know about lisdexamfetamine dimesylate chewable tablets?"
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with lisdexamfetamine dimesylate chewable tablets. Lisdexamfetamine dimesylate chewable tablets treatment may be stopped if your child is not growing or gaining weight.
• Circulation problems in fingers and toes (Peripheral vasculopathy, including Raynaud's phenomenon). Signs and symptoms may include:
  o Fingers or toes may feel numb, cool, painful
  o Fingers or toes may change color from pale, to blue, to red
  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 chewable tablets.
• Serotonin Syndrome. A potentially life-threatening problem called serotonin
  syndrome may happen when lisdexamfetamine dimesylate chewable tablets is taken
  with certain other medicines. Stop taking lisdexamfetamine dimesylate chewable
  tablets 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 chewable tablets in children 6 to 17 years old and adults with ADHD include:

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

These are not all the possible side effects of lisdexamfetamine dimesylate chewable tablets.
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 chewable tablets?

• Store lisdexamfetamine dimesylate chewable tablets 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 chewable tablets from light.
• Dispose of remaining, unused, or expired lisdexamfetamine dimesylate chewable tablets 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 chewable tablets 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 chewable tablets in the household trash.

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

General information about the safe and effective use of lisdexamfetamine dimesylate chewable tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lisdexamfetamine dimesylate for a condition for which it was not prescribed. Do not give lisdexamfetamine dimesylate to other people, even if they have the same symptoms that you have. It may harm them and it is against the law. You can ask your pharmacist or healthcare provider for information about lisdexamfetamine dimesylate that is written for health professionals.

What are the ingredients in lisdexamfetamine dimesylate chewable tablets?

Active ingredient: lisdexamfetamine dimesylate
Inactive Ingredients: Microcrystalline cellulose and guar gum, croscarmellose sodium, mannitol, sucralose, natural grape flavor, colloidal silicon dioxide, and magnesium stearate. Natural grape flavor contains maltodextrin, modified food starch (tapioca/waxy maize), natural flavor, triglycerides (medium chain), citric acid, tartaric acid and sodium benzoate.