Methylin Chewable Tablets (Methylphenidate HCl Chewable Tablets) Drug Information: Medication Guide and Patient Information

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May 27, 2012

Methylin Chewable Tablets

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ADHD medications are drugs used to treat some of the characteristic behaviors associated with attention deficit hyperactivity disorder, including inattention, hyperactivity, and poor impulse control.

Drugs used to treat ADHD target chemicals in the brain known as neurotransmitters. One type of ADHD medication works by increasing levels of the neurotransmitter dopamine. Another type of ADHD drug increases the level of another neurotransmitter, norepinephrine.

ADHD drug treatment should begin only after a specific diagnosis of ADHD has been made. A clinical diagnosis requires that symptoms have persisted for at least six months. There is no blood test or radiological scan that can diagnose ADHD.

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PATIENT INFORMATION

MEDICATION GUIDE

METHYLIN® CHEWABLE TABLETS
(methylphenidate HCl chewable tablets) 2.5 mg, 5 mg, and 10 mg

Read the Medication Guide that comes with METHYLIN® CHEWABLE TABLETS (methylphenidate hcl chewable tablets ) 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 METHYLIN® CHEWABLE TABLETS (methylphenidate hcl chewable tablets ) .

What is the most important information I should know about METHYLIN® Chewable Tablets?

The following have been reported with use of methylphenidate HCl 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 METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) .

Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) .

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 METHYLIN® Chewable Tablets.

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 METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) , especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) ?

METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) is a central nervous system stimulant prescription medicine. METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) are tablets that are made to be chewed and swallowed. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD).

METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) is also used in the treatment of a sleep disorder called narcolepsy.

METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep METHYLIN® Chewable Tablets in a safe place to prevent misuse and abuse. Selling or giving away METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) 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 METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) ?

METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) 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.
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 METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) . See the end of this Medication Guide for a complete list of ingredients.

METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) should not be used in children less than 6 years old because it has not been studied in this age group. METHYLIN® Chewable Tablets may not be right for you or your child. Before starting METHYLIN® Chewable Tablets 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)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) 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.

METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) 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 METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) .

Your doctor will decide whether METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) 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 METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) without talking to your doctor first.

How should METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) be taken?

Take METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) are usually taken 2 to 3 times a day.
Take METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) 30 to 45 minutes before a meal.

Chew METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) well and swallow with at least 8 ounces (a full glass) of water or other liquid. METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) can swell and cause choking if enough liquid is not taken with them. Get emergency medical care if you have chest pain, vomiting, or trouble swallowing, or breathing after taking a METHYLIN® Chewable tablet.

From time to time, your doctor may stop METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) treatment for awhile to check ADHD symptoms.
Your doctor may do regular checks of the blood, heart, and blood pressure while taking METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) . Children should have their height and weight checked often while taking METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) . METHYLIN® Chewable Tablets treatment may be stopped if a problem is found during these check-ups.
If you or your child takes too much METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) ?

See "What is the most important information I should know about METHYLIN® Chewable Tablets?" 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

Common side effects include:

nervousness
trouble sleeping
headache
stomach ache
fast heart beat
nausea
decreased appetite
dizziness
weight loss

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.

How should I store METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) ?

Store METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) in a safe place at room temperature, 68° to 77°F (20° to 25°C). Protect from moisture.
Keep METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) and all medicines out of the reach of children. General information about METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets )

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) for a condition for which it was not prescribed. Do not give METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) 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 METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) that was written for healthcare professionals. For more information, please contact Alliant Pharmaceuticals at 1-770-817-4500 or visit the website at www.methylin4kids.com.

What are the ingredients in METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) ?

CAUTION PHENYLKETOURICS: METHYLIN® Chewable Tablets (methylphenidate hcl chewable tablets ) contain phenylalanine.

Active Ingredient: methylphenidate HCl

Inactive Ingredients: aspartame NF, maltose, microcrystalline cellulose NF, guar gum NF, grape flavor, pregelatinized starch, NF, and stearic acid NF.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 8/11/2008
This monograph has been modified to include the generic and brand name in many instances.