Focalin XR (Dexmethylphenidate Hydrochloride) Drug Information: Medication Guide and Patient Information

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May 27, 2012

Focalin XR

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PATIENT INFORMATION

MEDICATION GUIDE

FOCALIN XR
(dexmethylphenidate hydrochloride) extended-release capsules CII

Read the Medication Guide that comes with FOCALIN XR (dexmethylphenidate hydrochloride) 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 FOCALIN XR (dexmethylphenidate hydrochloride) .

What is the most important information I should know about FOCALIN XR (dexmethylphenidate hydrochloride) ?

The following have been reported with use of dexmethylphenidate hydrochloride 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 FOCALIN XR (dexmethylphenidate hydrochloride) .

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with FOCALIN XR (dexmethylphenidate hydrochloride) .

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 XR.

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 FOCALIN XR (dexmethylphenidate hydrochloride) , especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is FOCALIN XR (dexmethylphenidate hydrochloride) ?

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

FOCALIN XR (dexmethylphenidate hydrochloride) should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

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

FOCALIN XR (dexmethylphenidate hydrochloride) 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 anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
are allergic to anything in FOCALIN XR (dexmethylphenidate hydrochloride) . See the end of this Medication Guide for a complete list of ingredients.

FOCALIN XR (dexmethylphenidate hydrochloride) should not be used in children less than 6 years old because it has not been studied in this age group.

FOCALIN XR (dexmethylphenidate hydrochloride) may not be right for you or your child. Before starting FOCALIN XR 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 breast-feeding.

Can FOCALIN XR (dexmethylphenidate hydrochloride) 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 XR (dexmethylphenidate hydrochloride) 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 XR (dexmethylphenidate hydrochloride) .

Your doctor will decide whether FOCALIN XR (dexmethylphenidate hydrochloride) 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
antacids
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 XR (dexmethylphenidate hydrochloride) without talking to your doctor first.

How should FOCALIN XR (dexmethylphenidate hydrochloride) be taken?

Take FOCALIN XR (dexmethylphenidate hydrochloride) exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
Take FOCALIN XR (dexmethylphenidate hydrochloride) once each day in the morning. FOCALIN XR (dexmethylphenidate hydrochloride) is an extended-release capsule. It releases medicine into your body throughout the day.
FOCALIN XR (dexmethylphenidate hydrochloride) can be taken with or without food. Taking FOCALIN XR (dexmethylphenidate hydrochloride) with food may slow the time it takes for the medicine to start working.
Swallow FOCALIN XR (dexmethylphenidate hydrochloride) capsules whole with water or other liquids. Do not chew, crush, or divide the capsules or the beads in the capsule. If you or your child cannot swallow the capsule, open it and sprinkle the small beads of medicine over a spoonful of applesauce and swallow it right away without chewing.
From time to time, your doctor may stop FOCALIN XR (dexmethylphenidate hydrochloride) treatment for a while to check ADHD symptoms.
Your doctor may do regular checks of the blood, heart, and blood pressure while taking FOCALIN XR (dexmethylphenidate hydrochloride) . Children should have their height and weight checked often while taking FOCALIN XR (dexmethylphenidate hydrochloride) . FOCALIN XR (dexmethylphenidate hydrochloride) treatment may be stopped if a problem is found during these check-ups.
If you or your child takes too much FOCALIN XR (dexmethylphenidate hydrochloride) or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of FOCALIN XR (dexmethylphenidate hydrochloride) ?

See “What is the most important information I should know about FOCALIN XR?” 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:

headache
upset stomach
trouble sleeping
anxiety

decreased appetite
dry mouth
dizziness
nervousness

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 XR (dexmethylphenidate hydrochloride) ?

Store FOCALIN XR (dexmethylphenidate hydrochloride) in a safe place at room temperature, 59 to 86° F (15 to 30° C).
Keep FOCALIN XR (dexmethylphenidate hydrochloride) and all medicines out of the reach of children.

General information about FOCALIN XR (dexmethylphenidate hydrochloride)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FOCALIN XR (dexmethylphenidate hydrochloride) for a condition for which it was not prescribed. Do not give FOCALIN XR (dexmethylphenidate hydrochloride) 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 XR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about FOCALIN XR (dexmethylphenidate hydrochloride) that was written for healthcare professionals. For more information about FOCALIN XR (dexmethylphenidate hydrochloride) call 1-888-669-6682.

What are the ingredients in FOCALIN XR?

Active Ingredient: dexmethylphenidate hydrochloride

Inactive Ingredients: ammonio methacrylate copolymer, FD&C Blue #2 (5 mg, 15 mg and 40 mg strengths), FDA/E172 yellow iron oxide (10 mg, 15 mg, 30 mg and 40 mg strengths), gelatin, ink Tan SW-8010, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate.

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

Last reviewed on RxList: 12/27/2010
This monograph has been modified to include the generic and brand name in many instances.