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

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

Dexmethylphenidate hydrochloride extended-release capsules is 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:

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

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:

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 about all of the medicines that you or your child takes including prescription and over-the-counter 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 the possible side effects of Dexmethylphenidate Hydrochloride Extended-Release Capsules?

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

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

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 it was not prescribed. Do not give dexmethylphenidate hydrochloride extended-release capsules to other people, even if they have the same symptoms that you have. It 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: Acetyltributyl citrate, ethylcellulose, gelatin, hypromellose, hypromellose acetate succinate, sugar spheres (which contain sucrose and starch) and talc. The 35 mg capsule also contains FD&C Blue #1 and titanium dioxide. Black printing ink SW-9008/SW-9009 contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.

Manufactured by:
Catalent Pharma Solutions

1100 Enterprise Drive
Winchester, KY 40391

Manufactured for:
Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

For more information, call 1-877-835-5472.

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

Revised: 03-2019-00

Revised: 6/2019
Amneal Pharmaceuticals of New York LLC