DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride tablet
Teva Pharmaceuticals USA, Inc.
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:
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:
Children and Teenagers
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
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:
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:
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:
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?
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, INC.
North Wales, PA 19454
Rev. H 4/2015