DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride capsule, extended release 
Amneal Pharmaceuticals of New York LLC

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MEDICATION GUIDE

Dexmethylphenidate Hydrochloride (dex-METH-il-FEN-i-date HYE-droe-KLOR-ide)

Extended-Release Capsules CII

Rx Only

Read the Medication Guide that comes with dexmethylphenidate hydrochloride 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 hydrochloride extended-release capsules.

What is the most important information I should know about Dexmethylphenidate Hydrochloride Extended-Release Capsules?

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

1. Heart-related problems:

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 hydrochloride 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 hydrochloride extended-release capsules.

2. Mental (Psychiatric) problems:

All Patients

Children and Teenagers

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.

What are Dexmethylphenidate Hydrochloride Extended-Release Capsules?

Dexmethylphenidate hydrochloride 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 hydrochloride extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

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

Dexmethylphenidate hydrochloride extended-release is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep dexmethylphenidate hydrochloride extended-release capsules in a safe place to prevent misuse and abuse. Selling or giving away dexmethylphenidate hydrochloride 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 Hydrochloride Extended-Release Capsules?

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

Dexmethylphenidate hydrochloride 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 hydrochloride extended-release capsules may not be right for you or your child. Before starting dexmethylphenidate hydrochloride 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 Hydrochloride 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 hydrochloride 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 hydrochloride extended-release capsules.

Your doctor will decide whether dexmethylphenidate hydrochloride 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 hydrochloride extended-release capsules without talking to your doctor first.

How should Dexmethylphenidate Hydrochloride Extended-Release Capsules be taken?

What are possible side effects of Dexmethylphenidate Hydrochloride Extended-Release Capsules?

See “What is the most important information I should know about Dexmethylphenidate Hydrochloride Extended-Release Capsules?” for information on reported heart and mental problems.

Other serious side effects include:

Common side effects include:

  ● headache  ● decreased appetite
  ● upset stomach  ● dry mouth
  ●troublesleeping  ● dizziness
  ● anxiety  ● 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 Hydrochloride Extended-Release Capsules?

General information about Dexmethylphenidate Hydrochloride Extended-Release Capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dexmethylphenidate hydrochloride extended-release capsules for a condition for which it was not prescribed. Do not give dexmethylphenidate hydrochloride 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 hydrochloride extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about dexmethylphenidate hydrochloride extended-release capsules that was written for healthcare professionals. For more information about dexmethylphenidate hydrochloride extended-release capsules call Impax Laboratories, Inc. at 1-800-934-6729.

What are the ingredients in Dexmethylphenidate Hydrochloride Extended-Release Capsules?

Active Ingredient: dexmethylphenidate hydrochloride

Inactive Ingredients: acetyltributyl citrate, ethylcellulose, gelatin, hypromellose, hypromellose acetate succinate, sugar spheres (which contain sucrose and starch [maize]), talc, and titanium dioxide. The 5 mg capsule also contains FD&C Red #3 and FD&C Blue #1.  The 10 mg capsule also contains acid red 27 and FD&C Blue #1. The 15 mg capsule also contains D&C Red #28 and FD&C Blue #1. The 20 mg capsule also contains D&C Red #28, D&C Red #33, and FD&C Blue #1. Black printing ink SW-9008/SW-9009 contains black iron oxide, potassium hydroxide, propylene glycol and shellac.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Manufactured by:
Catalent Pharma Solutions
1100 Enterprise Drive
Winchester, KY 40391

Distributed by:
Impax Generics
Hayward, CA 94544

Revised - January, 2017

LA-1860-02

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Revised: 12/2020
Amneal Pharmaceuticals of New York LLC