DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride tablet 
Tris Pharma Inc

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MEDICATION GUIDE

DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS

(dex-METH-il-FEN-i-date HYE-droe-KLOR-ide)

Read the Medication Guide that comes with Dexmethylphenidate Hydrochloride 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 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 the 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 Is Dexmethylphenidate Hydrochloride Tablets?

Dexmethylphenidate Hydrochloride Tablets is a central nervous system stimulant prescription medicine. It is 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 is a federally controlled substance (CII) because it 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:

Dexmethylphenidate Hydrochloride Tablets should not be used in children less than 6 years old because it has 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:

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

Can Dexmethylphenidate Hydrochloride Tablets be taken with other medicines?

Tell your doctor about all of the medicines that you or your child takes 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:

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?

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:

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.

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 Dexmethylphenidate Hydrochloride Tablets?

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 it was not prescribed. Do not give Dexmethylphenidate Hydrochloride 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 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 please contact Tris Pharma, Inc., at 732-940-0358 or go to www.trispharma.com.

What are the ingredients in Dexmethylphenidate Hydrochloride Tablets?

Active Ingredient: dexmethylphenidate hydrochloride

Inactive Ingredients: lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 aluminum lake (2.5 mg tablets), D&C Yellow Lake No.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.

Manufactured by:

Tris Pharma, Inc.

Monmouth Junction, NJ 08852

www.trispharma.com

LB8408 -PI

LB-8409 Medication Guide

Rev 00

10/2015

Revised: 10/2016
Tris Pharma Inc