(Methylphenidate HCl) Extended-Release Tablets, USP
Read the Medication Guide that comes with METADATE ER
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.
What is the most important information I should know
about METADATE ER?
The following have been reported with us e 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 ER.
Your doctor should check your or your child's blood
pressure and heart rate regularly during treatment with METADATE ER.
Call your doctor right away if you or your child has
any signs of heart problems such as chest pain, shortnes s of breath, or
fainting while taking METADATE ER.
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 depression.
Call your doctor right away if you or your child have
any new or worsening mental symptoms or problems while taking METADATE ER, 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 the fingers and 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 ER?
METADATE ER is a stimulant
prescription medicine. It is used for the treatment of Attention-Deficit
Hyperactivity Disorder (ADHD).
METADATE ER may help increase attention and decrease
impulsiveness and hyperactivity in patients with ADHD.
METADATE ER should be used as a part of a total treatment
program for ADHD that may include counseling or other therapies.
METADATE ER is a federally controlled substance (CII)
because it can be abused or lead to dependence. Keep METADATE ER in a safe place
to prevent misuse and abuse. Selling or giving away METADATE ER 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 ER?
METADATE ER 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. See the end of
this Medication Guide for a complete list of ingredients.
METADATE ER should not be used in children less than 6
years old because it has not been studied in this age group.
METADATE ER may not be right for you or your child.
Before starting METADATE ER 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 problems in fingers or toes
Tell your doctor if you or your child is pregnant,
planning to become pregnant, or breastfeeding.
Can METADATE ER 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 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.
Your doctor will decide whether METADATE ER 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 without talking to your doctor first.
How should METADATE ER be taken?
- Take METADATE ER exactly as prescribed. Your
doctor may adjust the dose until it is right for you or your child.
- Take METADATE ER once a day. METADATE ER is an extended
release tablet. It releases medicine into your body throughout the day.
- Do not chew or crush METADATE ER tablets. Swallow
METADATE ER tablets whole with water or other liquids. Tell your doctor if you
or your child cannot swallow METADATE ER whole. A different medicine may need
to be prescribed.
- From time to time, your doctor may stop METADATE ER
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. Children should have their height
and weight checked often while taking METADATE ER. METADATE ER treatment may be
stopped if a problem is found during these check-ups.
- If you or your child takes too much METADATE ER or
overdoses, call your doctor or poison control center right away, or get
What are possible side effects of METADATE ER?
See “What is the most important information I should
know about METADATE ER?” 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
- 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.
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 ER?
- Store METADATE ER in a safe place at room temperature, 59
to 86° F (15 to 30° C). Protect from moisture.
- Keep METADATE ER and all medicines out of the reach of
General information about METADATE ER
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use METADATE ER for a condition
for which it was not prescribed. Do not give METADATE ER 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. If you would like more information, talk with
your doctor. You can ask your doctor or pharmacist for information about
METADATE ER that was written for healthcare professionals. For more information
about METADATE ER call 1-866-822-0068.
What are the ingredients in METADATE ER?
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.