Metadate ER

Metadate ER is part of the drug class:

• Centrally acting sympathomimetics

Serious side effects have been reported with Metadate ER. See the “Metadate ER Precautions” section.

Common side effects of Metadate ER include the following:

• headache
• decreased appetite
• nausea and vomiting
• stomach pain
• diarrhea
• heartburn
• nervousness
• restlessness
• trouble falling asleep or staying asleep
• dizziness
• nausea
• changes in heart rate or blood pressure
• rapid or flutter heart rate (palpitations)

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Metadate ER is usually taken once or twice a day, in the morning and sometimes in the early afternoon 30 to 45 minutes before a meal.

Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.

Methylphenidate may also be used for purposes not listed in this medication guide.

Do not take methylphenidate if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you use methylphenidate before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to methylphenidate or if you have:

• glaucoma;
• overactive thyroid;
• severe high blood pressure;
• angina (chest pain), heart failure, heart rhythm disorder, or recent heart attack;
• a personal or family history of tics (muscle twitches) or Tourette's syndrome;
• severe anxiety, tension, or agitation (methylphenidate can make these symptoms worse); or
• a hereditary condition such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Tell your doctor if you have a congenital heart defect.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• a congenital heart defect;
• a personal or family history of mental illness, psychotic disorder, bipolar illness, depression, or suicide attempt;
• epilepsy or other seizure disorder; or
• a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether methylphenidate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether methylphenidate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Long-term use of methylphenidate can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Do not give methylphenidate to a child younger than 6 years old without the advice of a doctor.

Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use methylphenidate if you are allergic to it, or if you have:

• glaucoma;

• a personal or family history of tics (muscle twitches) or Tourette's syndrome; or

• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• motor tics (muscle twitches) or Tourette's syndrome;

• blood circulation problems in the hands or feet;

• seizures or epilepsy;

• problems with the esophagus, stomach, or intestines;

• an abnormal brain wave test (EEG); or

• a history of drug or alcohol addiction.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether methylphenidate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Methylphenidate is not approved for use by anyone younger than 6 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is later than 6:00 p.m. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methylphenidate could be fatal.

In the U.S.

• Aptensio XR
• Concerta
• Cotempla XR-ODT
• Metadate CD
• Metadate ER
• Methylin
• Methylin ER
• QuilliChew ER
• Quillivant XR
• Ritalin
• Ritalin LA
• Ritalin-SR

Available Dosage Forms:

• Tablet, Extended Release, Disintegrating
• Capsule, Extended Release
• Tablet, Extended Release, Chewable
• Tablet, Extended Release
• Powder for Suspension, Extended Release
• Solution
• Tablet, Chewable
• Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Metadate ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are available as follows:

20 mg: Round, white, uncoated, unscored, debossed "562 MD".
     NDC 65580-594-01   Bottle of 100's

NOTE: Metadate ER Tablets are color-additive free.

Store at 20° - 25°C (68°-77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Protect from moisture.

Pharmacist

Dispense in a tight container as defined in the USP with a child-resistant closure.

For Medical Information

Contact: UCBCares™
Phone: (844) 599-2273
Fax: (770) 970-8859

Manufactured for
Upstate Pharma, LLC
Smyrna, GA 30080

Rev. 02/2017
METADATE is a registered trademark of the UCB Group of companies

© 2017, UCB, Inc., Smyrna, GA 30080 All rights reserved.

Applies to methylphenidate: oral capsule extended release, oral powder for suspension extended release, oral solution, oral tablet, oral tablet chewable, oral tablet extended release, oral tablet extended release chewable

Other dosage forms:

• transdermal patch extended release

Along with its needed effects, methylphenidate (the active ingredient contained in Metadate ER) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking methylphenidate:

• Fast heartbeat

• Chest pain
• fever
• joint pain
• skin rash or hives

• Black, tarry stools
• blood in the urine or stools
• blurred vision or other changes in vision
• crusting, dryness, or flaking of the skin
• muscle cramps
• pinpoint red spots on the skin
• scaling, severe redness, soreness, or swelling of the skin
• seizures
• uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)
• unusual bleeding or bruising

• Confusion
• depression
• feeling like surroundings are not real
• numbness of the hands
• painful or difficult urination
• pale skin
• paleness or cold feeling in the fingertips and toes
• red, irritated eyes
• red, swollen, or scaly skin
• seeing, hearing, or feeling things that are not there
• severe or sudden headache
• sores, ulcers, or white spots on the lips or in the mouth
• sudden loss of coordination
• sudden slurring of speech
• tingling or pain in the fingers or toes when exposed to cold
• unusual behavior
• unusual tiredness or weakness
• weight loss
• yellow skin or eyes

Get emergency help immediately if any of the following symptoms of overdose occur while taking methylphenidate:

• Agitation
• anxiety
• bigger, dilated, or enlarged pupils of the eyes
• confusion as to time, place, or person
• dark-colored urine
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry eyes, mouth, nose, or throat
• false or unusual sense of well-being
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• holding false beliefs that cannot be changed by fact
• increased sensitivity of the eyes to light
• loss of consciousness
• muscle pain or stiffness
• muscle twitching
• nervousness
• overactive reflexes
• pounding in the ears
• rapid, shallow breathing
• sweating
• tremors
• unusual excitement, nervousness, or restlessness

Some side effects of methylphenidate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• loss of appetite
• nervousness
• stomach pain
• stuffy nose
• trouble sleeping
• unusually warm skin

• Anger
• decreased appetite
• dizziness
• drowsiness
• fear
• irritability
• muscle aches
• nausea
• runny nose
• scalp hair loss
• talking, feeling, and acting with excitement
• vomiting