METHYLPHENIDATE HYDROCHLORIDE (LA)- methylphenidate hydrochloride capsule, extended release 
Teva Pharmaceuticals USA, Inc.

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MEDICATION GUIDE

Methylphenidate Hydrochloride (meth″ il fen′ i date hye″ droe klor′ ide)
Extended-Release Capsules LA CII

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

Methylphenidate hydrochloride extended-release capsules are a federal controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride extended-release capsules in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride extended-release capsules may harm others, and is against the law. Tell your doctor if you or your child have ever 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:

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 methylphenidate hydrochloride extended-release capsules.

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

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 methylphenidate hydrochloride extended-release capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What are methylphenidate hydrochloride extended-release capsules?

Methylphenidate hydrochloride extended-release capsules are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Methylphenidate hydrochloride extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

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

It is not known if methylphenidate hydrochloride extended-release capsules are safe and effective in children under 6 years of age.

Who should not take methylphenidate hydrochloride extended-release capsules?

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

Methylphenidate hydrochloride extended-release capsules may not be right for you or your child. Before starting methylphenidate 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 take including prescription and over- the-counter medicines, vitamins, and herbal supplements. Methylphenidate 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 methylphenidate hydrochloride extended-release capsules.

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

How should
methylphenidate hydrochloride extended-release capsules be taken?

In case of poisoning, call your poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.

What are possible side effects of methylphenidate 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:

  • fast heart beat
  • abnormal
    heartbeat
    (palpitations)
  • headache
  • trouble
    sleeping
  • nervousness
  • sweating a lot
  • decreased
    appetite
  • dry mouth
  • nausea
  • stomach 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
methylphenidate hydrochloride extended-release capsules?

General information about the safe and effective use methylphenidate 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 methylphenidate hydrochloride extended-release capsules that is written for healthcare professionals. Do not use methylphenidate hydrochloride extended-release capsules for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride extended-release capsules to other people, even if they have the same symptoms. It may harm them and it is against the law.

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

Active Ingredient: methylphenidate HCL

Inactive Ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10.

Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

For more information about methylphenidate hydrochloride extended-release capsules call 1-888-838-2872.

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




Revised: 12/2019
Teva Pharmaceuticals USA, Inc.