CONCERTA- methylphenidate hydrochloride tablet, extended release
Janssen Pharmaceuticals, Inc.
CONCERTA® (kon SER-ta)
(methylphenidate HCl) Extended-release Tablets CII
Read the Medication Guide that comes with CONCERTA® 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 CONCERTA®.
The following have been reported with use of methylphenidate HCl and other stimulant medicines:
1. Heart-related problems:
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 CONCERTA®.
Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with CONCERTA®.
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 CONCERTA®.
2. Mental (Psychiatric) problems:
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 has any new or worsening mental symptoms or problems while taking CONCERTA®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
3. Painful and prolonged erections (priapism)
Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.
4. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]:
Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your 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 CONCERTA®.
What is CONCERTA®?
CONCERTA® is a central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). CONCERTA® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
CONCERTA® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
CONCERTA® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep CONCERTA® in a safe place to prevent misuse and abuse. Selling or giving away CONCERTA® may harm others, and is against the law.
Tell your doctor if you or your child has (or has a family history of) ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Who should not take CONCERTA®?
CONCERTA® should not be taken if you or your child:
CONCERTA® should not be used in children less than 6 years old because it has not been studied in this age group.
CONCERTA® may not be right for you or your child. Before starting CONCERTA®, 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 CONCERTA® 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. CONCERTA® 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 CONCERTA®.
Your doctor will decide whether CONCERTA® 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 CONCERTA® without talking to your doctor first.
How should CONCERTA® be taken?
What are possible side effects of CONCERTA®?
See "What is the most important information I should know about CONCERTA®?" for information on reported heart and mental problems.
Other serious side effects include:
|Common side effects include:|
Stimulants may impair the ability of you or your child to operate potentially hazardous machinery or vehicles. You or your child should exercise caution until you or your child is reasonably certain that CONCERTA® does not adversely affect your or your child's ability to engage in such activities.
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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN or (1-800-526-7736).
How should I store CONCERTA®?
General information about CONCERTA®
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CONCERTA® for a condition for which it was not prescribed. Do not give CONCERTA® 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 CONCERTA®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about CONCERTA® that was written for healthcare professionals. For more information about CONCERTA® call 1-800-526-7736.
Active Ingredient: methylphenidate HCl
Inactive Ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Janssen-Cilag Manufacturing, LLC
Gurabo, Puerto Rico 00778 or
Vacaville, CA 95688
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
Revised: December 2013