DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE- dexmethylphenidate hydrochloride capsule, extended release 
Lannett Company, Inc.

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MEDICATION GUIDE

Dexmethylphenidate Hydrochloride (Dex-meth-ill-FEN-ĭ-date Hī-dro-KLOR-īd) Extended-Release Capsules CII

Read the Medication Guide that comes with dexmethylphenidate HCl extended-release capsules before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with dexmethylphenidate HCl extended-release capsules.

What is the most important information I should know about dexmethylphenidate HCl extended-release capsules?

The following have been reported with use of dexmethylphenidate HCl and other stimulant medicines.

1. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting dexmethylphenidate HCl extended-release capsules.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride extended-release capsules.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking dexmethylphenidate HCl extended-release capsules.

2. Mental (Psychiatric) problems:

All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking dexmethylphenidate hydrochloride extended-release capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.

  • Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
  • Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking dexmethylphenidate hydrochloride extended-release capsules.

What are dexmethylphenidate HCl extended-release capsules?

Dexmethylphenidate HCl extended-release capsules are a central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Dexmethylphenidate HCl extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Dexmethylphenidate HCl extended-release capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Dexmethylphenidate HCl extended-release capsules are a federally controlled substance (CII) because they can be abused or lead to dependence. Keep dexmethylphenidate HCl extended-release capsules in a safe place to prevent misuse and abuse. Selling or giving away dexmethylphenidate HCl extended-release capsules may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take dexmethylphenidate HCl extended-release capsules?

Dexmethylphenidate HCl extended-release capsules should not be taken if you or your child:

Dexmethylphenidate HCl extended-release capsules should not be used in children less than 6 years old because it has not been studied in this age group.

Dexmethylphenidate HCl extended-release capsules may not be right for you or your child. Before starting dexmethylphenidate HCl extended-release capsules tell your or your child’s doctor about all health conditions (or a family history of) including:

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can dexmethylphenidate HCl extended-release capsules be taken with other medicines?

Tell your doctor about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Dexmethylphenidate HCl extended-release capsules and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking dexmethylphenidate HCl extended-release capsules.

Your doctor will decide whether dexmethylphenidate HCl extended-release capsules can be taken with other medicines.

Especially tell your doctor if you or your child takes:

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking dexmethylphenidate HCl extended-release capsules without talking to your doctor first.

How should dexmethylphenidate HCl extended-release capsules be taken?

What are possible side effects of dexmethylphenidate HCl extended-release capsules?

See “What is the most important information I should know about dexmethylphenidate HCl extended-release capsules?” for information on reported heart and mental problems.

Other serious side effects include:

Common side effects include:

  • headache
  • upset stomach
  • trouble sleeping
  • anxiety
  • decreased appetite
  • dry mouth
  • dizziness
  • nervousness

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

How should I store dexmethylphenidate HCl extended-release capsules?

General information about dexmethylphenidate HCl extended-release capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dexmethylphenidate HCl extended-release capsules for a condition for which it was not prescribed. Do not give dexmethylphenidate HCl extended-release capsules to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about dexmethylphenidate HCl extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about dexmethylphenidate HCl extended-release capsules that was written for healthcare professionals. For more information about dexmethylphenidate HCl extended-release capsules call 1-877-731-5116.

What are the ingredients in dexmethylphenidate HCl extended-release capsules?

Active Ingredient: dexmethylphenidate hydrochloride

Inactive Ingredients: ammonio methacrylate copolymer, D&C Red #28 (5 mg, 25 mg and 35 mg strengths), edible printing ink Red SB-1010N containing Shellac NF and Carmine Powder Red, FD&C Blue #1 (5 mg, 15 mg, 25 mg, 35 mg and 40 mg strengths), FDA/E172 Yellow Iron Oxide (15 mg and 40 mg strengths), gelatin, methacrylic acid copolymer, Opadry Clear containing hypromellose and polyethylene glycol, povidone, sugar spheres containing corn starch as well as sugar syrup and sucrose derived from sugar cane, talc, titanium dioxide, and triethyl citrate.

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

Distributed by

Lannett Company, Inc.

Philadelphia, PA 19154

L6884 Rev. 09/2018

Revised: 9/2018
Lannett Company, Inc.