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Important Safety Information

WARNING: ABUSE, MISUSE, AND ADDICTION

Dextroamphetamine sulfate has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate, can result in overdose and death. This risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

  • Your healthcare provider (HCP) should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with ProCentra and will monitor you or your child during treatment.
  • ProCentra may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
  • Tell your HCP if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

ProCentra is a federally controlled substance (CII) because it contains dextroamphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep ProCentra in a safe place, like a locked cabinet, to protect it from theft. Dispose of remaining, unused, or expired ProCentra by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. See Medication Guide or visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. Never give your ProCentra to anyone else because it may cause death or harm them. Selling or giving away ProCentra may harm others and is against the law. Keep ProCentra and all medicines out of the reach of children.

What is the Most Important Safety Information I Should Know About ProCentra?

ProCentra may cause serious side effects, including:

  • Heart related problems in people with serious cardiac disease. Sudden death has happened in people who have heart defects or other serious heart disease. Tell your HCP if you or your child have any heart problems, heart disease, or heart defects. Call your HCP right away or go to the nearest hospital emergency room (ER) right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with ProCentra.
  • Increased blood pressure and heart rate. Your HCP should check you or your child’s blood pressure and heart rate regularly during treatment with ProCentra.
  • Mental (psychiatric) problems, including new or worse behavior or thought problems, new or worse bipolar illness, new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms. Tell your HCP about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your HCP right away if you or your child have any new or worsening mental symptoms or problems during treatment with ProCentra, especially hearing voices, seeing, or believing things that are not real, or new manic symptoms.
  • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with ProCentra. Your HCP may stop your child’s ProCentra treatment if they are not growing or gaining weight as expected.
  • Seizures. Your HCP may stop treatment with ProCentra if you or your child have a seizure.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Tell your HCP if you or your child’s fingers or toes feel numb, cool, painful or change color from pale, to blue, to red or if they are sensitive to temperature. Call your HCP right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with ProCentra.
  • New or worsening tics or worsening Tourette’s syndrome. Tell your HCP if you or your child have or had repeated movements or sounds (tics) or Tourette’s syndrome, or a family history of tics or Tourette’s syndrome.
  • Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome may happen when ProCentra is taken with certain other medicines. Stop taking ProCentra and call your HCP or go to the nearest hospital ER right away if you or your child develop any of the following signs and symptoms of serotonin syndrome: agitation, changes in blood pressure, coma, confusion, diarrhea, dizziness, fast heartbeat, flushing, high body temperature (hyperthermia), loss of coordination, muscle twitching, nausea, seeing or hearing things that are not real (hallucination), seizures, stiff muscles, sweating, tremors, vomiting.

Do not take ProCentra if you or your child:

  • are allergic to amphetamine products or any of the ingredients in ProCentra. See Medication Guide for a complete list of ingredients in ProCentra.
  • are taking or have taken within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or the intravenous medicine methylene blue.

Tell your healthcare provider about all the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ProCentra and some medicines may interact with each other and cause serious side effects. Your HCP will decide if ProCentra can be taken with other medicines. Do not start any new medicine during treatment with ProCentra without talking to your HCP first.

Before taking ProCentra, tell your HCP about all medical conditions, including if you or your child:

  • are pregnant or plan to become pregnant. It is not known if ProCentra will harm the unborn baby. Tell your HCP if you or your child become pregnant during treatment with ProCentra.
  • are breastfeeding or plan to breastfeed. ProCentra passes into breastmilk. You or your child should not breastfeed during treatment with ProCentra. Talk to your HCP about the best way to feed the baby during treatment with ProCentra.

What are possible side effects of ProCentra?

The most common side effects of ProCentra are:

  • fast heartbeat
  • decreased appetite
  • tremors
  • headache
  • trouble sleeping
  • dizziness
  • stomach upset
  • weight loss
  • dry mouth

These are not all the possible side effects of ProCentra. If you or your child take too much ProCentra, call your HCP or Poison Help line at 1-800-222-1222 or go to the nearest hospital ER right away.

Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how ProCentra affects you.

What is ProCentra?

Procentra is a central nervous system (CNS) stimulant prescription medicine used for the treatment of a sleep disorder called narcolepsy and Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 3 years of age to 16 years of age. ProCentra is not for use in children under 3 years of age.

For additional safety information click here for the Full Prescribing Information and Medication Guide and discuss with your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Prasco is committed to helping ensure the proper use of stimulant medication. Resources are available on our website.

For more information about ProCentra, call Prasco LLC at 1-866-525-0688.