MEDICATION GUIDE

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

Dexmethylphenidate hydrochloride extended-release is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep dexmethylphenidate hydrochloride extended-release in a safe place to prevent misuse and abuse. Selling or giving away dexmethylphenidate hydrochloride extended-release 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 methylphenidate 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 extended-release.

   Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride extended-release.

   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-releasecapsules.

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 extended-releasecapsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What is dexmethylphenidate hydrochloride extended-release?

• Dexmethylphenidate hydrochloride extended-release is a central nervous system stimulant (CNS) prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Dexmethylphenidate hydrochloride extended-release may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
• Dexmethylphenidate hydrochloride extended-release 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 extended-releasecapsules?

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. See the end of this Medication Guide for a complete list of ingredients in dexmethylphenidate hydrochloride extended-release.

• 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 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 extended-release will harm your unborn baby.

• There is a pregnancy registry for females who are exposed to ADHD medications, including dexmethylphenidate hydrochloride extended-release, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to dexmethylphenidate hydrochloride extended-release and their baby. If you or your child becomes pregnant during treatment with dexmethylphenidate hydrochloride extended-release, 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 extended-release 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.

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 extended-release 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.

Your doctor will decide whether dexmethylphenidate hydrochloride extended-release 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 extended-release 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-releasecapsules without talking to your doctor first.

How should dexmethylphenidate hydrochloride extended-release capsulesbe taken?

• Take dexmethylphenidate hydrochloride extended-release exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
• Take dexmethylphenidate hydrochloride extended-release once each day in the morning. Dexmethylphenidate hydrochloride extended-release is an extended-release capsule.
• Dexmethylphenidate hydrochloride extended-release can be taken with or without food. Taking dexmethylphenidate hydrochloride extended-release 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.
• From time to time, your doctor may stop dexmethylphenidate hydrochloride extended-release 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 extended-release.
• Children should have their height and weight checked often while taking dexmethylphenidate hydrochloride extended-release. Dexmethylphenidate hydrochloride extended-release 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 extended-releasecapsules? Dexmethylphenidate hydrochloride extended-release capsules may cause serious side effects, including:

• See “What is the most important information I should know about dexmethylphenidate hydrochloride extended-release?” 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):
  • fingers or toes may feel numb, cool, painful
  • 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 extended-release.
• Slowing of growth (height and weight) in children

  Common side effects include:

  Children (6 to 17 years)

• dyspepsia ●decreased appetite ●headache●anxiety

  Adults

• dry mouth ● dyspepsia●headache●anxiety●pharyngolaryngeal pain

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?

• Store dexmethylphenidate hydrochloride extended-release capsules in a safe place and in a tightly closed container at 20°C to 25°C (68°F to 77°F).
• Dispose of remaining, unused, or expired dexmethylphenidate hydrochloride extended-release 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 extended-release 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 extended-release in the household trash.
• Keep dexmethylphenidate hydrochloride extended-release 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 doctor for information about dexmethylphenidate hydrochloride extended-release that is written for healthcare professionals. Do not use dexmethylphenidate hydrochloride extended-release for a condition for which it was not prescribed. Do not give dexmethylphenidate hydrochloride extended-release to other people, even if they have the same symptoms that you have. It may harm them and it is against the law.