METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride tablet 
Actavis Pharma, Inc.

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MEDICATION GUIDE


Methylphenidate Hydrochloride Tablets, USP CII
(meth" il fen' i date hye" droe klor' ide)

Read the Medication Guide that comes with methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets.

What is the most important information I should know about methylphenidate hydrochloride tablets? 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 has 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 tablets.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride tablets.

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 tablets.

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 methylphenidate hydrochloride tablets, 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 methylphenidate hydrochloride tablets

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

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

Methylphenidate hydrochloride tablets are also used in the treatment of a sleep disorder called narcolepsy.

Methylphenidate hydrochloride tablets are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride tablets in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets?

Methylphenidate hydrochloride tablets should not be taken if you or your child:

Methylphenidate hydrochloride tablets should not be used in children less than 6 years old because it has not been studied in this age group.

Methylphenidate hydrochloride tablets may not be right for you or your child. Before starting methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets 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. Methylphenidate hydrochloride tablets 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 tablets.

Your doctor will decide whether methylphenidate hydrochloride tablets 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 tablets without talking to your doctor first.

How should methylphenidate hydrochloride tablets be taken?

What are possible side effects of methylphenidate hydrochloride tablets?

See “What is the most important information I should know about methylphenidate hydrochloride tablets?” for information on reported heart and mental problems.

Other serious side effects include:

Common side effects include:

•  headache
•  stomach ache
•  trouble sleeping
•  nausea
•  decreased appetite
•  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 methylphenidate hydrochloride tablets?

General information about methylphenidate hydrochloride tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate hydrochloride tablets for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about methylphenidate hydrochloride tablets that was written for healthcare professionals. For more information about methylphenidate hydrochloride tablets call 1-800-272-5525.

What are the ingredients in methylphenidate hydrochloride tablets?
Active Ingredient: methylphenidate HCL
Inactive Ingredients: colloidal silicon dioxide, compress­ible sugar, lactose monohydrate and magnesium stearate. Additionally, the 5 mg contains FD&C Blue #2 and FD&C Red #40; the 10 mg contains FD&C Blue #2 and D&C Yellow #10; and the 20 mg contains FD&C Yellow #6.

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:
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: October 2016

Revised: 10/2016
Actavis Pharma, Inc.