DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride tablet 
Tris Pharma Inc

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MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: March 2019

MEDICATION GUIDE
Dexmethylphenidate Hydrochloride
(dex-meth-ill-FEN-ih-date)
Tablets CII 

What is the most important information I should know about Dexmethylphenidate hydrochloride tablets?
Dexmethylphenidate hydrochloride tablets is a federal 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 abused or been dependent on alcohol, prescription medicines, or street drugs.
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 you 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
• 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.
What is Dexmethylphenidate hydrochloride tablets?
• Dexmethylphenidate hydrochloride tablets are a central nervous system stimulant (CNS) prescription medicine. It is used for the treatment of Attention-Deficit 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.
Who should not take Dexmethylphenidate hydrochloride tablets:
Dexmethylphenidate hydrochloride tablets should not be taken if you or your child:
• are allergic to methylphenidate hydrochloride, or any of the ingredients in dexmethylphenidate hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in dexmethylphenidate hydrochloride tablets.
• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
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
• circulation problems in fingers or toes
• if you are pregnant or plan to become pregnant. It is not known if dexmethylphenidate hydrochloride tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• if you are breastfeeding or plan to breastfeed. Dexmethylphenidate hydrochloride passes into your breast milk. You and your doctor should decide if you will take dexmethylphenidate hydrochloride tablets or breastfeed.
Tell your doctor about all of the medicines that you or your child takes including prescription and over-the-counter 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
• blood pressure medicines (anti-hypertensive)
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
• You should not take dexmethylphenidate hydrochloride tablets on the day of your operation if a certain type of anesthetic is used. This is because there is a chance of a sudden rise in blood pressure and heart rate during the operation.
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 daily, at least 4 hours apart.
• Dexmethylphenidate hydrochloride tablets may be taken with or without food.
• From time to time, your doctor may stop dexmethylphenidate hydrochloride tablets 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 tablets treatment may be stopped if a problem is found during these check-ups.
• In case of poisoning call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.
What are the possible side effects of Dexmethylphenidate hydrochloride tablets?
Dexmethylphenidate hydrochloride tablets may cause serious side effects, including:
• See “What is the most important information I should know about dexmethylphenidate hydrochloride tablets?” for information on reported heart and mental problems.
• painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.
• circulation problems in fingers and toes (Peripheral Vasculopathy, including Raynaud’s phenomenon):
     o fingers or toes may feel numb, cool, painful
     o fingers or toes may change color from pale, to blue, to red
     Tell your doctor if you or your child have, 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.
• slowing of growth (height and weight) in children
Common side effects include:
• abdominal pain • fever • anorexia • nausea
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?
• Store dexmethylphenidate hydrochloride tablets in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect from light.
• Dispose of remaining, unused, or expired dexmethylphenidate hydrochloride tablets by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix dexmethylphenidate hydrochloride tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away (discard) dexmethylphenidate hydrochloride tablets in the household trash.
• Keep dexmethylphenidate hydrochloride tablets and all medicines out of the reach of children.
General information about the safe and effective use of Dexmethylphenidate hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about dexmethylphenidate hydrochloride tablets that is written for healthcare professionals. 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 symptoms that you have. It may harm them and it is against the law.
What are the ingredients in Dexmethylphenidate hydrochloride tablets?
Active ingredient: dexmethylphenidate hydrochloride
Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, 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.

Manufacured by:
Tris Pharma, Inc.
Monmouth Junction, NJ 08852

LB8408
Rev. 02
03/2019

Revised: 3/2019
Tris Pharma Inc