DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride capsule, extended release
Teva Pharmaceuticals USA Inc
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Dexmethylphenidate (dex meth ill FEN i date) Hydrochloride Extended-Release Capsules CII
Read the Medication Guide that comes with dexmethylphenidate hydrochloride extended-release capsules 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 extended-release capsules.
What is the most important information I should know about dexmethylphenidate hydrochloride extended-release capsules?
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 has 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 extended-release capsules.
Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride extended-release capsules.
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 extended-release capsules.
2. Mental (Psychiatric) problems:
All Patients
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 extended-release capsules, 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 extended-release capsules?
Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system stimulant prescription medicine. They are used for the treatment of attention deficit and hyperactivity disorder (ADHD). Dexmethylphenidate hydrochloride extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Dexmethylphenidate hydrochloride extended-release capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Dexmethylphenidate hydrochloride extended-release capsules are a federally controlled substance (CII) because they can be abused or lead to dependence. Keep dexmethylphenidate hydrochloride extended-release capsules in a safe place to prevent misuse and abuse. Selling or giving away dexmethylphenidate hydrochloride extended-release capsules 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 extended-release capsules?
Dexmethylphenidate hydrochloride extended-release capsules should not be taken if you or your child:
Dexmethylphenidate hydrochloride extended-release capsules should not be used in children less than 6 years old because they have not been studied in this age group.
Dexmethylphenidate hydrochloride extended-release capsules may not be right for you or your child. Before starting dexmethylphenidate hydrochloride extended-release capsules 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 extended-release capsules 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 extended-release capsules 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 extended-release capsules.
Your doctor will decide whether dexmethylphenidate hydrochloride extended-release capsules 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 extended-release capsules without talking to your doctor first.
How should dexmethylphenidate hydrochloride extended-release capsules be taken?
What are possible side effects of dexmethylphenidate hydrochloride extended-release capsules?
See “What is the most important information I should know about dexmethylphenidate hydrochloride extended-release capsules?” 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.
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 extended-release capsules?
General information about dexmethylphenidate hydrochloride extended-release capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dexmethylphenidate hydrochloride extended-release capsules for a condition for which they were not prescribed. Do not give dexmethylphenidate hydrochloride extended-release capsules 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 extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about dexmethylphenidate hydrochloride extended-release capsules that was written for healthcare professionals. For more information about dexmethylphenidate hydrochloride extended-release capsules call 1-888-838-2872.
What are the ingredients in dexmethylphenidate hydrochloride extended-release capsules?
Active Ingredient: dexmethylphenidate hydrochloride
Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, non-pareil seeds (which contain corn starch and sucrose), polyethylene glycol, propylene glycol, shellac glaze, talc, titanium dioxide and triethyl citrate. Additionally, the 30 mg capsules contain D&C yellow no. 10 and the 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. B 1/2014