MEDICATION GUIDE

What is the most important information I should know about dexmethylphenidate hydrochloride extended-release capsules?

Dexmethylphenidate hydrochloride extended-release capsules may cause serious side effects, including:

• Abuse, misuse, and addiction. Dexmethylphenidate hydrochloride extended-release capsules have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of dexmethylphenidate hydrochloride extended-release capsules, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of dexmethylphenidate hydrochloride extended-release capsules or when they are used in ways that are not approved, such as snorting or injection.

• Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with dexmethylphenidate hydrochloride extended-release capsules and will monitor you or your child during treatment.
• Dexmethylphenidate hydrochloride extended-release capsules may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
• Do not give dexmethylphenidate hydrochloride extended-release capsules to anyone else. See “What is dexmethylphenidate hydrochloride extended-release capsules?” for more information.
• Keep dexmethylphenidate hydrochloride extended-release capsules in a safe place and properly dispose of any unused medicine. See “How should I store dexmethylphenidate hydrochloride extended-release capsules?” for more information.
• Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

• Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease.

  Your healthcare provider should check you or your child carefully for heart problems before starting dexmethylphenidate hydrochloride extended-release capsules. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

  Call your healthcare provider or go to the nearest hospital emergency room 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.

• Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride extended-release capsules.
• Mental (psychiatric) problems:
  All Patients

• new or worse behavior and thought problems
• new or worse bipolar illness
• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider 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.

What are dexmethylphenidate hydrochloride extended-release capsules?

• Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system stimulant (CNS) prescription medicine. They are used for the treatment of Attention-Deficit 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 contain dexmethylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep dexmethylphenidate hydrochloride extended-release capsules in a safe place to protect them from theft. Never give your dexmethylphenidate hydrochloride extended-release capsules to anyone else because they may cause death or harm them. Selling or giving away dexmethylphenidate hydrochloride extended-release capsules may harm others and is against the law.

Who should not take dexmethylphenidate hydrochloride extended-release capsules?

Dexmethylphenidate hydrochloride extended-release capsules should not be taken if you or your child:

• are allergic to methylphenidate hydrochloride, or any of the ingredients in dexmethylphenidate hydrochloride extended-release capsules. See the end of this Medication Guide for a complete list of ingredients in dexmethylphenidate hydrochloride extended-release capsules.
• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI).

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 healthcare provider about all health conditions (or a family history of), including:

• heart problems, heart disease, heart defects, or high blood pressure
• mental problems, including psychosis, mania, bipolar illness, or depression
• circulation problems in fingers or toes
• have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
• have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome.
• if you are pregnant or plan to become pregnant. It is not known if dexmethylphenidate hydrochloride extended-release capsules will harm your unborn baby.
  • There is a pregnancy registry for females who are exposed to ADHD medications, including dexmethylphenidate hydrochloride extended-release capsules, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to dexmethylphenidate hydrochloride extended-release capsules and their baby. If you or your child becomes pregnant during treatment with dexmethylphenidate hydrochloride extended-release capsules, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD medications at
    1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.
• if you are breastfeeding or plan to breastfeed. Dexmethylphenidate hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with dexmethylphenidate hydrochloride extended-release capsules.

  Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter 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 healthcare provider will decide whether dexmethylphenidate hydrochloride extended-release capsules can be taken with other medicines.

  Especially tell your healthcare provider 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 healthcare provider and pharmacist.

• You should not take dexmethylphenidate hydrochloride extended-release capsules 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 extended-release capsules without talking to your healthcare provider first.

How should dexmethylphenidate hydrochloride extended-release capsules be taken?

• Take dexmethylphenidate hydrochloride extended-release capsules exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child.
• Take dexmethylphenidate hydrochloride extended-release capsules once each day in the morning. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release capsule.
• Dexmethylphenidate hydrochloride extended-release capsules can be taken with or without food. Taking dexmethylphenidate hydrochloride extended-release capsules with food may slow the time it takes for the medicine to start working.
• Swallow dexmethylphenidate hydrochloride extended-release capsules whole with water or other liquids. Do not chew, crush, or divide the capsules or the beads in the capsule. If you or your child cannot swallow the capsule, open it and sprinkle the small beads of medicine over a spoonful of applesauce and swallow it right away without chewing.
• Your healthcare provider may do regular checks of the blood, heart, and blood pressure while taking dexmethylphenidate hydrochloride extended-release capsules.
• Children should have their height and weight checked often while taking dexmethylphenidate hydrochloride extended-release capsules. Dexmethylphenidate hydrochloride extended-release capsule treatment may be stopped if a problem is found during these check-ups.
  
  If you or your child take too many dexmethylphenidate hydrochloride extended-release capsules, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

How should I store dexmethylphenidate hydrochloride extended-release capsules?

• Store dexmethylphenidate hydrochloride extended-release capsules in a safe place and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).
• Dispose of remaining, unused, or expired dexmethylphenidate hydrochloride extended-release capsules by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix dexmethylphenidate hydrochloride extended-release capsules 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 dexmethylphenidate hydrochloride extended-release capsules in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicine.
• Keep dexmethylphenidate hydrochloride extended-release capsules and all medicines out of the reach of children.

General information about the safe and effective use of dexmethylphenidate hydrochloride
extended-release capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about dexmethylphenidate hydrochloride extended-release capsules that is written for healthcare professionals. 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 symptoms that you have. They may harm them and it is against the law.

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/indigo carmine 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, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3.

Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054

For more information, call 1-888-838-2872.