Methylphenidate Hydrochloride Extended Release Tablet

METADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.

Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is:

Methylphenidate hydrochloride is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its chemical formula is C14H19NO2 •HCl, and its molecular weight is 269.77.

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

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

20 mg: Round, white, uncoated, unscored, debossed “562 MD”.

NDC 53014-594-07 Bottle of 100's

NOTE: METADATE ER Tablets are color-additive free.

Pharmacist

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

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.

For Medical Information

Contact: Medical Affairs Department
Phone: (866) 822-0068
Fax: (770) 970-8859

Manufactured for: UCB, Inc., Smyrna, GA 30080. Revised: Dec 2014

Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.

Consult with a Certified Poison Control Center regarding treatment for up-to-date guidance and advice.

Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage. In the presence of severe intoxication, use a carefully titrated dosage of a short-acting barbiturate before performing gastric lavage. Other measures to detoxify the gut include administration of activated charcoal and a cathartic.

Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.

Efficacy of peritoneal dialysis or extracorporeal hemodialysis for methylphenidate overdosage has not been established.

METADATE® ER
(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 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.

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 :

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, 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 METADATE ER.

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 emergency treatment.

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 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
• 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:

• 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.

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 children.

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.

Methylphenidate may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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