METADATE CD - methylphenidate hydrochloride capsule, extended release
Physicians Total Care, Inc.
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METADATE CD®
(methylphenidate HCl, USP) Extended-Release Capsules CII
Read the Medication Guide that comes with METADATE CD 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 METADATE CD.
What is the most important information I should know about Metadate CD?
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these 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.
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What Is METADATE CD?
METADATE CD is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).
METADATE CD may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
METADATE CD should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
METADATE CD is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep METADATE CD in a safe place to prevent misuse and abuse. Selling or giving away METADATE CD 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 METADATE CD?
METADATE CD should not be taken if you or your child:
METADATE CD should not be used in children less than 6 years old because it has not been studied in this age group.
METADATE CD may not be right for you or your child. Before starting METADATE CD 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 METADATE CD be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. METADATE CD 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 METADATE CD.
Your doctor will decide whether METADATE CD 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 METADATE CD without talking to your doctor first.
How should METADATE CD be taken?
What are possible side effects of METADATE CD?
See "What is the most important information I should know about METADATE CD?" for information on reported heart and mental problems.
Other serious side effects include:
Common side effects include:
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.
How should I store METADATE CD?
General information about METADATE CD
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use METADATE CD for a condition for which it was not prescribed. Do not give METADATE CD 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 METADATE CD. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about METADATE CD that was written for healthcare professionals. For more information about METADATE CD call 1-866-822-0068.
What are the ingredients in METADATE CD?
Active Ingredient: methylphenidate HCl
Inactive Ingredients: sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethylcellulose aqueous dispersion, dibutyl sebacate, gelatin, and titanium dioxide.
The individual capsules contain the following coloring agents:
10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide
20 mg capsules: FD&C Blue No. 2
30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide
40 mg capsules: FDA/E172 Yellow Iron Oxide
50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Marketed by UCB, Inc.
Smyrna, GA 30080
Manufactured by UCB Manufacturing, Inc.
Rochester, NY 14623
METADATE CD is a registered trademark of the UCB Group of companies
©2009, UCB, Inc., Smyrna, GA 30080
All rights reserved. Printed in U.S.A.
2E 06/2009