(methylphenidate HCl, USP) Extended-Release Capsules
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?
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
- 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
Your doctor should check you or your child carefully for
heart problems before starting METADATE CD.
Your doctor should check your or your child's blood
pressure and heart rate regularly during treatment with METADATE CD.
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:
- 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
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.
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 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
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:
- 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 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 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)
- circulation problem in fingers and toes
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
- anti-depression medicines including MAOIs seizure
- 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 CD
without talking to your doctor first.
How should METADATE CD be taken?
Take METADATE CD exactly as prescribed. Your
doctor may adjust the dose until it is right for you or your child.
- 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.
- METADATE CD can be taken with or without food.
- 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 capsule.
- METADATE CD should not be taken with alcohol. This may
result in a more rapid release of the dose of METADATE CD.
- From time to time, your doctor may stop METADATE CD
treatment for a while to check ADHD symptoms.
- 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 METADATE CD. METADATE CD treatment may be
stopped if a problem is found during these check-ups.
- If you or your child takes too much METADATE CD or
overdoses, call your doctor or poison control center right away, or get
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
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
- 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.
Common side effects include:
- decreased appetite
- stomach ache
- trouble sleeping
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?
- Store METADATE CD in a safe place at Â room temperature,
59 to 86° F (15 to 30° Â C). Protect from moisture.
- Keep METADATE CD and all medicines out of the reach of
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
10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron
20 mg capsules: FD&C Blue No. 2
30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron
40 mg capsules: FDA/E172 Yellow Iron Oxide
50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Marketed by UCB, Inc. Smyrna, GA 30080. Rev. 06/2014