(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 childâEUR(TM)s treatment with

What is the most important
information I should know about
Metadate CD?

The following have been reported with
use of methylphenidate HCl, USP and
other stimulant medicines.

1. Heart-related problems:
âEUR¢ sudden death in patients who have
heart problems or heart defects
âEUR¢ stroke and heart attack in adults
âEUR¢ increased blood pressure and heart

Tell your doctor if you or your child have
any heart problems, heart defects, high
blood pressure, or a family history of these

Your doctor should check you or your child
carefully for heart problems before starting

Your doctor should check your or your
childâEUR(TM)s blood pressure and heart rate
regularly during treatment with

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 CD.

2. Mental (Psychiatric) problems:
All Patients
âEUR¢ new or worse behavior and thought
âEUR¢ new or worse bipolar illness
âEUR¢ new or worse aggressive behavior or

Children and Teenagers
âEUR¢ 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

Call your doctor right away if you or your
child have any new or worsening mental
symptoms or problems while taking
METADATE CD, especially seeing or
hearing things that are not real, believing
things that are not real, or are suspicious.


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

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 childâEUR(TM)s
doctor about all health conditions (or a
family history of) including:
âEUR¢ heart problems, heart defects, high blood
âEUR¢ mental problems including psychosis,
mania, bipolar illness, or depression
âEUR¢ tics or TouretteâEUR(TM)s syndrome
âEUR¢ 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

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

Your doctor will decide whether
METADATE CD can be taken with other

Especially tell your doctor if you or your
child takes:
âEUR¢ anti-depression medicines including
âEUR¢ seizure medicines
âEUR¢ blood thinner medicines
âEUR¢ blood pressure medicines
âEUR¢ cold or allergy medicines that contain

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

âEUR¢ Take METADATE CD exactly as
prescribed. Your doctor may adjust the
dose until it is right for you or your
âEUR¢ Take METADATE CD once each day in
the morning before breakfast.
METADATE CD is an extended release
capsule. It releases medicine into your
body throughout the day.
âEUR¢ METADATE CD can be taken with or
without food.
âEUR¢ Swallow METADATE CD capsules
whole with water or other liquids. If you
cannot swallow the capsule, open it and
sprinkle the medicine over a spoonful of
applesauce. Swallow the applesauce and
medicine mixture without chewing.
Follow with a drink of water or other
liquid. Never chew or crush the
capsule or the medicine inside the
âEUR¢ From time to time, your doctor may stop
METADATE CD treatment for a while
to check ADHD symptoms.
âEUR¢ Your doctor may do regular checks of
the blood, heart, and blood pressure
while taking METADATE CD.
Children should have their height and
weight checked often while taking
treatment may be stopped if a problem is
found during these check-ups.
âEUR¢ If you or your child takes too much
METADATE CD or overdoses, call
your doctor or poison control center
right away, or get emergency

What are possible side effects of

See âEURoeWhat is the most important
information I should know about
METADATE CD?âEUR for information on
reported heart and mental problems.

Other serious side effects include:
âEUR¢ slowing of growth (height and weight) in
âEUR¢ seizures, mainly in patients with a
history of seizures
âEUR¢ eyesight changes or blurred vision

Common side effects include:
âEUR¢ headache
âEUR¢ decreased appetite
âEUR¢ stomach ache
âEUR¢ nervousness
âEUR¢ trouble sleeping
âEUR¢ dizziness

Talk to your doctor if you or your child has
side effects that are bothersome or do not go

This is not a complete list of possible side
effects. Ask your doctor or pharmacist for
more information.

How should I store METADATE CD?
âEUR¢ Store METADATE CD in a safe place at
room temperature, 59 to 86° F (15 to 30°
C). Protect from moisture.
âEUR¢ Keep METADATE CD and all
medicines out of the reach of children