DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride capsule, extended release 
Teva Pharmaceuticals USA, Inc.

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MEDICATION GUIDE

Dexmethylphenidate (dex" meth il fen' i date) Hydrochloride (hye" droe klor' ide) 
Extended-Release Capsules CII

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

Dexmethylphenidate hydrochloride extended-release capsules are a federal 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 abused or been dependent on alcohol, prescription medicines, or street drugs.

The following have been reported with use of methylphenidate hydrochloride 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 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

• new or worse behavior and thought problems

• new or worse bipolar illness

new or worse aggressive behavior or hostility

• 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.

What are dexmethylphenidate hydrochloride extended-release capsules?

Who should not take dexmethylphenidate hydrochloride extended-release capsules?

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

  • are allergic to methylphenidate hydrochloride, or any of the ingredients in dexmethylphenidate hydrochloride extended-release capsules. See the end of this Medication Guide for a complete list of ingredients in dexmethylphenidate hydrochloride extended-release capsules.
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.

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:

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 the possible side effects of dexmethylphenidate hydrochloride extended-release capsules?

Dexmethylphenidate hydrochloride extended-release capsules may cause serious side effects, including:

Tell your doctor if you or your child have, numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.

Common side effects include:

Children (6 to 17 years)

● dyspepsia        ● decreased appetite        ● headache        ● anxiety

Adults

● dry mouth       ● dyspepsia                      ● headache        ● anxiety        ● pharyngolaryngeal pain

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 dexmethylphenidate hydrochloride extended-release capsules?

General information about the safe and effective use of dexmethylphenidate hydrochloride extended-release capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about dexmethylphenidate hydrochloride extended-release capsules that is written for healthcare professionals. Do not use dexmethylphenidate hydrochloride extended-release capsules for a condition for which they were not prescribed. Do not give dexmethylphenidate hydrochloride extended-release capsules to other people, even if they have the same symptoms that you have. They may harm them and it is against the law.

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

Active ingredient: dexmethylphenidate hydrochloride

Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, non-pareil seeds (which contain corn starch and sucrose), polyethylene glycol, propylene glycol, shellac glaze, talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.

For more information, call 1-888-838-2872.

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

This Medication Guide has been approved by the U.S. Food and Drug Administration                                    Rev. G 12/2019

Revised: 12/2019
Teva Pharmaceuticals USA, Inc.