What is the most important information I should know about FOCALIN?

The following have been reported with use of dexmethylphenidate hydrochloride and other stimulant medicines.

1. Heart-related problems:
âEUR¢ sudden death in patients who have heart problems or heart defects
âEUR¢ stroke and heart attack in adults
âEUR¢ 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 FOCALIN®.

Your doctor should check your or your childâEUR(TM)s blood pressure and heart rate regularly during treatment with FOCALIN®.

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 FOCALIN®.

2. Mental (Psychiatric) problems:
All Patients
âEUR¢ new or worse behavior and thought problems
âEUR¢ new or worse bipolar illness
âEUR¢ new or worse aggressive behavior or hostility

Children and Teenagers
âEUR¢ new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic

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
FOCALIN®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.


FOCALIN® is a central nervous system stimulant prescription medicine. It is used for the treatment of
attention deficit and hyperactivity disorder (ADHD). FOCALIN® may help increase attention and decrease
impulsiveness and hyperactivity in patients with ADHD.

FOCALIN® should be used as a part of a total treatment program for ADHD that may include counseling or other

FOCALIN® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep FOCALIN®
in a safe place to prevent misuse and abuse. Selling or giving away FOCALIN® 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 FOCALIN®?

FOCALIN® should not be taken if you or your child:
âEUR¢ are very anxious, tense, or agitated
âEUR¢ have an eye problem called glaucoma
âEUR¢ have tics or TouretteâEUR(TM)s syndrome, or a family history of TouretteâEUR(TM)s syndrome. Tics are hard to control
repeated movements or sounds.
âEUR¢ are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase
inhibitor or MAOI.
âEUR¢ are allergic to anything in FOCALIN®. See the end of this Medication Guide for a complete list of

FOCALIN® should not be used in children less than 6 years old because it has not been studied in this age group.

FOCALIN® may not be right for you or your child. Before starting FOCALIN® tell your or your childâEUR(TM)s
doctor about all health conditions (or a family history of) including:

âEUR¢ heart problems, heart defects, high blood pressure
âEUR¢ mental problems including psychosis, mania, bipolar illness, or depression
âEUR¢ tics or TouretteâEUR(TM)s syndrome
âEUR¢ seizures or have had an abnormal brain wave test (EEG)
Can FOCALIN® 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. FOCALIN® 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 FOCALIN®.

Your doctor will decide whether FOCALIN® can be taken with other medicines.

Especially tell your doctor if you or your child takes:
âEUR¢ anti-depression medicines including MAOIs
âEUR¢ seizure medicines
âEUR¢ blood thinner medicines
âEUR¢ blood pressure medicines
âEUR¢ 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 FOCALIN® without talking to your doctor first.
How should FOCALIN® be taken?

âEUR¢ Take FOCALIN exactly as prescribed. Your doctor may adjust the dose until it is right for you or your
âEUR¢ Take FOCALIN® twice a day, at least 4 hours apart.
âEUR¢ FOCALIN® can be taken with or without food.
âEUR¢ From time to time, your doctor may stop FOCALIN® treatment for a while to check ADHD symptoms.
âEUR¢ Your doctor may do regular checks of the blood, heart, and blood pressure while taking FOCALIN®.
Children should have their height and weight checked often while taking FOCALIN®. FOCALIN®
treatment may be stopped if a problem is found during these check-ups.
âEUR¢ If you or your child takes too much FOCALIN® or overdoses, call your doctor or poison control
center right away, or get emergency treatment.

What are possible side effects of FOCALIN®?

See âEURoeWhat is the most important information I should know about FOCALIN®?âEUR for information on
reported heart and mental problems.

Other serious side effects include:
âEUR¢ slowing of growth (height and weight) in children
âEUR¢ seizures, mainly in patients with a history of seizures
âEUR¢ eyesight changes or blurred vision

Common side effects include:
âEUR¢ stomach ache âEUR¢ decreased appetite
âEUR¢ nausea âEUR¢ fever

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 FOCALIN®?

âEUR¢ Store FOCALIN® in a safe place at room temperature, 59 to 86° F (15 to 30° C).

âEUR¢ Keep FOCALIN® and all medicines out of the reach of children.

General information about FOCALIN®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use
FOCALIN® for a condition for which it was not prescribed. Do not give FOCALIN® 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 FOCALIN®. If you would like more
information, talk with your doctor. You can ask your doctor or pharmacist for information about FOCALIN®
that was written for healthcare professionals.

What are the ingredients in FOCALIN®?

Active Ingredient: dexmethylphenidate hydrochloride
Inactive Ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline
cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake
#10 (5 mg tablets); the 10 mg tablet contains no dye.

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