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MEDICATION GUIDE

METADATE® ER
(methylphenidate HCl extended-release tablets, USP) Tablets CII

Read the Medication Guide that comes with METADATE ER (methylphenidate hydrochloride tablet) 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 ER (methylphenidate hydrochloride tablet) .

What is the most important information I should know about METADATE ER (methylphenidate hydrochloride tablet) ?

The following have been reported with use of methylphenidate HCl, USP 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 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 METADATE ER (methylphenidate hydrochloride tablet) .

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with METADATE ER (methylphenidate hydrochloride tablet) .

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 METADATE ER (methylphenidate hydrochloride tablet) .

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 METADATE ER (methylphenidate hydrochloride tablet) , especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is METADATE ER (methylphenidate hydrochloride tablet) ?

METADATE ER (methylphenidate hydrochloride tablet) is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

METADATE ER (methylphenidate hydrochloride tablet) may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

METADATE ER (methylphenidate hydrochloride tablet) should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Who should not take METADATE ER (methylphenidate hydrochloride tablet) ?

METADATE ER (methylphenidate hydrochloride tablet) should not be taken if you or your child:

• are very anxious, tense, or agitated
• have an eye problem called glaucoma
• have tics or Tourette's syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated movements or sounds.
• have severe high blood pressure or a heart problem
• have hyperthyroidism
• are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
• are allergic to anything in METADATE ER (methylphenidate hydrochloride tablet) . See the end of this Medication Guide for a complete list of ingredients.

METADATE ER (methylphenidate hydrochloride tablet) should not be used in children less than 6 years old because it has not been studied in this age group. METADATE ER (methylphenidate hydrochloride tablet) may not be right for you or your child. Before starting METADATE ER (methylphenidate hydrochloride tablet) tell your or your child's doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette's syndrome
• seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can METADATE ER (methylphenidate hydrochloride tablet) 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 ER (methylphenidate hydrochloride tablet) 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 ER (methylphenidate hydrochloride tablet) .

Your doctor will decide whether METADATE ER (methylphenidate hydrochloride tablet) can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs
• seizure medicines
• blood thinner medicines
• blood pressure medicines
• cold or allergy medicines that contain decongestants

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 ER (methylphenidate hydrochloride tablet) without talking to your doctor first.

How should METADATE ER (methylphenidate hydrochloride tablet) be taken?

• Take METADATE ER (methylphenidate hydrochloride tablet) exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
• Take METADATE ER (methylphenidate hydrochloride tablet) once a day. METADATE ER (methylphenidate hydrochloride tablet) is an extended release tablet. It releases medicine into your body throughout the day.
• Do not chew or crush METADATE ER (methylphenidate hydrochloride tablet) tablets. Swallow METADATE ER tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow METADATE ER (methylphenidate hydrochloride tablet) whole. A different medicine may need to be prescribed.
• From time to time, your doctor may stop METADATE ER (methylphenidate hydrochloride tablet) treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking METADATE ER (methylphenidate hydrochloride tablet) . Children should have their height and weight checked often while taking METADATE ER (methylphenidate hydrochloride tablet) . METADATE ER (methylphenidate hydrochloride tablet) treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much METADATE ER (methylphenidate hydrochloride tablet) or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of METADATE ER (methylphenidate hydrochloride tablet) ?

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

Other serious side effects include:

• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision

Common side effects include:

• headache
• decreased appetite
• stomach ache
• nervousness
• trouble sleeping
• dizziness
• nausea
• heart palpitations

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 METADATE ER (methylphenidate hydrochloride tablet) ?

• Store METADATE ER (methylphenidate hydrochloride tablet) in a safe place at room temperature, 59 to 86° F (15 to 30° C). Protect from moisture.
• Keep METADATE ER (methylphenidate hydrochloride tablet) and all medicines out of the reach of children.

General information about METADATE ER (methylphenidate hydrochloride tablet)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use METADATE ER (methylphenidate hydrochloride tablet) for a condition for which it was not prescribed. Do not give METADATE ER (methylphenidate hydrochloride tablet) 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 ER (methylphenidate hydrochloride tablet) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about METADATE ER (methylphenidate hydrochloride tablet) that was written for healthcare professionals. For more information about METADATE ER (methylphenidate hydrochloride tablet) call 1-866-822-0068.

What are the ingredients in METADATE ER (methylphenidate hydrochloride tablet) ?

Active Ingredient: methylphenidate HCl

Inactive Ingredients: cetyl alcohol, ethylcellulose, anhydrous lactose and magnesium stearate.

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

Last reviewed on RxList: 5/26/2009
This monograph has been modified to include the generic and brand name in many instances.