DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride tablet 
Teva Pharmaceuticals USA Inc

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MEDICATION GUIDE FOR DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS, CII

Rx only

Read the Medication Guide that comes with dexmethylphenidate hydrochloride tablets before you or your child starts taking them 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 dexmethylphenidate hydrochloride tablets.

What is the most important information I should know about dexmethylphenidate hydrochloride tablets?

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 dexmethylphenidate hydrochloride tablets.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride 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 dexmethylphenidate hydrochloride 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 dexmethylphenidate hydrochloride tablets, 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 your fingers or 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 dexmethylphenidate hydrochloride tablets

What are dexmethylphenidate hydrochloride tablets?

Dexmethylphenidate hydrochloride tablets are a central nervous system stimulant prescription medicine. They are used for the treatment of attention deficit and hyperactivity disorder (ADHD). Dexmethylphenidate hydrochloride tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Dexmethylphenidate hydrochloride tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Dexmethylphenidate hydrochloride tablets are a federally controlled substance (CII) because they can be abused or lead to dependence. Keep dexmethylphenidate hydrochloride tablets in a safe place to prevent misuse and abuse. Selling or giving away dexmethylphenidate hydrochloride 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 dexmethylphenidate hydrochloride tablets?

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

Dexmethylphenidate hydrochloride tablets should not be used in children less than 6 years old because they have not been studied in this age group.

Dexmethylphenidate hydrochloride tablets may not be right for you or your child. Before starting dexmethylphenidate hydrochloride 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)
  • circulation problems in fingers or toes

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.

Can dexmethylphenidate hydrochloride 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. Dexmethylphenidate hydrochloride 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 dexmethylphenidate hydrochloride tablets.

Your doctor will decide whether dexmethylphenidate hydrochloride 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 dexmethylphenidate hydrochloride tablets without talking to your doctor first.

How should dexmethylphenidate hydrochloride tablets be taken?

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

What are possible side effects of dexmethylphenidate hydrochloride tablets?

See “What is the most important information I should know about dexmethylphenidate hydrochloride tablets?” for information on reported heart and mental problems.

Other serious side effects include:

  • Serious allergic reactions (symptoms can be difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever)
  • 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:

  • stomach ache
  • decreased appetite
  • nausea
  • 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 dexmethylphenidate hydrochloride tablets?

  • Store dexmethylphenidate hydrochloride tablets in a safe place at room temperature, 20° to 25°C (68° to 77°F).
  • Keep dexmethylphenidate hydrochloride tablets and all medicines out of the reach of children.

General information about dexmethylphenidate hydrochloride tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dexmethylphenidate hydrochloride tablets for a condition for which they were not prescribed. Do not give dexmethylphenidate hydrochloride tablets to other people, even if they have the same condition. They may harm them and it is against the law.

This Medication Guide summarizes the most important information about dexmethylphenidate hydrochloride tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about dexmethylphenidate hydrochloride tablets that was written for healthcare professionals. For more information about dexmethylphenidate hydrochloride tablets call 1-888-838-2872.

What are the ingredients in dexmethylphenidate hydrochloride tablets?

Active Ingredient: dexmethylphenidate hydrochloride

Inactive Ingredients: lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. Additionally, 5 mg tablets contain D&C Yellow #10 aluminum lake; 2.5 mg tablets contain FD&C Blue #2 lake; 5 mg and 10 mg tablets contain colloidal silicon dioxide.

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

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

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. F 12/2013

Revised: 01/2014
 
Teva Pharmaceuticals USA Inc