LISDEXAMFETAMINE DIMESYLATE- lisdexamfetamine dimesylate capsule 
Apotex Corp.



LisdexamfetamineDimesylate (lis dex”am fet’ a meen dye mes’ i late) Capsules, CII

Medication Guide available at

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’s blood pressure and heart rate regularly during treatment with lisdexamfetamine dimesylate capsules.

What are lisdexamfetamine dimesylate capsules?

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

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

Lisdexamfetamine dimesylate capsules are not for weight loss. It is not known if lisdexamfetamine dimesylate capsules are safe and effective for the treatment of obesity. It is not known if lisdexamfetamine dimesylate capsules are safe and effective for use in children with BED.

Lisdexamfetamine dimesylate capsules 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 capsules in a safe place to protect it from theft. Never give your lisdexamfetamine dimesylate capsules to anyone else because it may cause death or harm them. Selling or giving away lisdexamfetamine dimesylate capsules may harm others and is against the law.

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

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

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:

  • selective serotonin reuptake inhibitors (SSRIs)
  • medicines used to treat migraine headaches called triptans
  • lithium
  • tramadol
  • buspirone
  • serotonin norepinephrine reuptake inhibitors (SNRIs)
  • tricyclic antidepressants
  • fentanyl
  • tryptophan
  • St. John’s Wort

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?

Taking lisdexamfetamine Dimesylate Capsules:

If you or your child take too much lisdexamfetamine dimesylate capsules, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of lisdexamfetamine dimesylate capsules? 

Lisdexamfetamine dimesylate capsules may cause serious side effects, including:

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

  • loss of appetite (anorexia)
  • decreased appetite
  • diarrhea
  • dry mouth
  • trouble sleeping
  • stomach pain
  • anxiety
  • weight loss
  • dizziness
  • irritability
  • nausea
  • vomiting

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

  • dry mouth
  • decreased appetite
  • constipation
  • anxiety
  • trouble sleeping
  • increased heart rate
  • feeling jittery

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?

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

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

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lisdexamfetamine dimesylate capsules for a condition for which it was not prescribed. Do not give lisdexamfetamine dimesylate capsules 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 capsules that is written for healthcare professionals.

What are the ingredients in lisdexamfetamine dimesylate capsules? 

Active ingredient: lisdexamfetamine dimesylate

Capsule Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The capsule shells contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28 (70 mg), FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg and 30 mg), FD&C Red #40 (70 mg), FD&C Yellow #6 (30 mg and 70 mg), iron oxide black (40 mg), and iron oxide yellow (20 mg and 40 mg). The imprinting ink of the 10 mg capsules contains iron oxide black, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. The imprinting ink of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac glaze.



10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg

Manufactured by:
Frontida Biopharm, LLC
1100 Orthodox Street
Philadelphia, PA 19124
Manufactured for:
Apotex Corp.
Weston, Florida
USA 33326  

Rev. 5

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 11/2023

Revised: 12/2023
Apotex Corp.