What is the most important information I should know about Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules?

Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules can cause serious side effects, including:

• Abuse and dependence. Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules.
  • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs.
  • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
• Heart-related problems, including:
  • sudden death, stroke, and heart attack in adults
  • sudden death in people who have heart problems or heart defects
  • increased blood pressure and heart rate 

  Your healthcare provider should check you or your child carefully for heart problems before starting Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules. Tell your healthcare provider if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

  Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules.

  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 during treatment with Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules.

• Mental (psychiatric) problems, including:
  • new or worse behavior and 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 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 Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

 What are Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules?

Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 13 years of age and older.

Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are not for use in children 12 years of age and younger. 
Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules in a safe place to protect it from theft. Never give Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules to anyone else, because it may cause death or harm them. Selling or giving away Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules may harm others and is against the law.

 Do not take Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules if you or your child are:

• allergic to amphetamine or any of the ingredients in Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules. See the end of the Medication Guide for a complete list of ingredients in Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules.
• taking, or have taken within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

 Before taking Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules, tell your or your healthcare provider about all medical conditions, including if you or your child:

• have heart problems, heart defects or high blood pressure
• have mental problems including psychosis, mania, bipolar illness or depression, or have a family history of suicide, bipolar illness, or depression.
• have circulation problems in fingers and toes
• have or have had seizures
• have kidney problems. You should not take Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules if you have end stage renal disease (ESRD).
• are pregnant or plan to become pregnant. It is not known if Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules.
  • There is a pregnancy registry for females who are exposed to Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules and their baby. If you or your child becomes pregnant during treatment with Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/research/pregnancyregistry/.
• are breastfeeding or plan to breastfeed. Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules pass into breast milk. You should not breastfeed during treatment with Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules.

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

Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules may affect the way other medicines work and other medicines may affect how Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules work. Taking Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules with other medicines can cause serious side effects.

Especially tell your healthcare provider if you or your child take medicines used to treat depression including MAOIs.

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your or your child’s healthcare provider and pharmacist when you or your child get a new medicine.

Your healthcare provider will decide whether Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules can be taken with other medicines. Do not start any new medicine during treatment with Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules without talking to your or your child’s healthcare provider first.

 How should I take Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules?

• Take Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules exactly as prescribed by your healthcare provider.

• Your healthcare provider may change the dose if needed.

• Take Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules 1 time each day in the morning right after you wake-up. Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules may last up to 16 hours and can cause difficulty sleeping.

• If you miss a dose of Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules, do not take your dose later in the day or double your dose to make up for a missed dose. Take your Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules dose the next morning at your regularly scheduled time.

• Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules can be taken with or without food but take it the same way each time.

• Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules may be swallowed whole or if Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules cannot be swallowed whole, the capsules may be opened and sprinkled over a spoonful of applesauce.

  • swallow all of the applesauce and medicine mixture right away

  • do not chew the applesauce and medicine mixture

  • do not store the sprinkled applesauce

• Your healthcare provider may sometimes stop Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules treatment for a while to check ADHD symptoms.

• If you or your child takes too many Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules, call your healthcare provider or go to the nearest hospital emergency room right away.

 What are possible side effects of Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules?

Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules can cause serious side effects, including:

• See “What is the most important information I should know about Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules?"
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules. Your healthcare provider may stop your child’s Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules treatment if they are not growing or gaining weight as expected.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
  • fingers or toes may feel numb, cool, painful
  • fingers or toes may change color from pale, to blue, to red

  Tell your healthcare provider if you have or your child has any numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

  Call your healthcare provider if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules.

• Seizures. Your healthcare provider will stop treatment with Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules if you have a seizure.
• Serotonin syndrome. This problem may happen when Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are taken with certain other medicines and may be life-threatening. Call your healthcare provider or go to the nearest hospital emergency room if you get symptoms of serotonin syndrome which may include: 
  • agitation, hallucinations, coma, or other changes in mental status
  • problems controlling movements or muscle twitching
  • fast heartbeat
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle stiffness or tightness

The most common side effects of Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules include:

• trouble sleeping
• decreased appetite
• dry mouth
• increased heart rate
• anxiety
• nausea
• irritability
• weight loss

These are not all the possible side effects of Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules.

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 Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules?

• Store Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules from light.
• Store Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules in a safe place, like a locked cabinet.
• Dispose of remaining, unused, or expired Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules 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 Mixed Salts of a Single-Entity Amphetamine Product 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 Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules in the household trash.

Keep Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules and all medicines out of the reach of children.

 General information about the safe and effective use of Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules for a condition for which it was not prescribed. Do not give Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules to other people, even if they have the same condition. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules that was written for healthcare professionals.