MEDICATION GUIDE

Adderall® may cause serious side effects, including:

• Abuse, misuse, and addiction. Adderall® has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Adderall®, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Adderall® or when it is 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 Adderall® and will monitor you or your child during treatment.
• Adderall® may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
• Do not give Adderall® to anyone else. See “What is Adderall®?” for more information.
• Keep Adderall® in a safe place and properly dispose of any unused medicine. See “How should I store Adderall®?” 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 treatment with Adderall®. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

Call your healthcare provider right away or go to the nearest hospital emergency room 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 Adderall®.

• 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 Adderall®.

• 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 during treatment with Adderall®, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What is Adderall®?

Adderall® is a central nervous system stimulant (CNS) prescription medicine used for the treatment of:

• Attention-Deficit Hyperactivity Disorder (ADHD) in children 3 to 17 years of age. Adderall® may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
• a sleep disorder called Narcolepsy in people 6 years and older.

It is not known if Adderall® is safe and effective in children with ADHD under 3 years of age.

It is not known if Adderall® is safe and effective in children with Narcolepsy under 6 years of age.

Adderall® is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Adderall® in a safe place to protect it from theft. Never give your Adderall® to anyone else because it may cause death or harm them. Selling or giving away Adderall® may harm others and is against the law.

Do not take Adderall® if you or your child:

• are allergic to amphetamine products or any of the ingredients in Adderall®. See the end of this Medication Guide for a complete list of ingredients in Adderall®.
• 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.

Before taking Adderall®, tell your healthcare provider about all of your or your child’s medical conditions,  including if you or your child:

• have heart problems, heart disease, 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 kidney problems, including end stage renal disease (ERSD)
• have seizures or have had an abnormal brain wave test (EEG)
• have circulation problems in fingers or toes
• have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
• are pregnant or plan to become pregnant. It is not known if Adderall® will harm the unborn baby. Tell your healthcare provider if you or your child become pregnant during treatment with Adderall®.
• are breastfeeding or plan to breastfeed. Adderall® passes into breast milk. You or your child should not breastfeed during treatment with Adderall®. Talk to your healthcare provider about the best way to feed the baby during treatment with Adderall®.

Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Adderall® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with Adderall®.

Your healthcare provider will decide if Adderall® can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

• selective serotonin reuptake inhibitors (SSRIs)
• medicines used to treat migraine headaches called triptans
• lithium
• tramadol
• buspirone
• serotonin norepinephrine reuptake inhibitors (SNRIs)
• tricyclic antidepressants
• fentanyl
• tryptophan
• St. John’s Wort

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

Do not start any new medicine during treatment with Adderall® without talking to your healthcare provider first.

How should Adderall® be taken?

• Take Adderall® exactly as prescribed by your or your child’s healthcare provider.
• Your healthcare provider may change the dose if needed.
• The first dose of the day is usually taken when you first wake up.
• Adderall® can be taken with or without food.
• Your healthcare provider may sometimes stop Adderall® treatment for a while to check ADHD symptoms.

If you or your child take too much Adderall®, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

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

What are possible side effects of Adderall®?

Adderall® may cause serious side effects, including:

• See “What is the most important information I should know about Adderall®?”
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Adderall®. Your healthcare provider may stop your child’s Adderall® treatment if they are not growing or gaining weight as expected.
• Seizures. Your healthcare provider may stop treatment with Adderall® if you or your child have a seizure.
• 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 right away if you have or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Adderall®.

• Serotonin syndrome. This problem may happen when Adderall® is taken with certain other medicines and may be life-threatening. Stop taking Adderall® and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome:

• agitation, hallucinations, coma

• fast heartbeat

• flushing

• seizures
• loss of coordination

• confusion
• dizziness
• changes in blood pressure
• sweating or fever
• nausea, vomiting, or diarrhea
• muscle stiffness or tightness
• high body temperature (hyperthermia)

• New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with Adderall®.

The most common side effects of Adderall® include:

• stomach ache
• decreased appetite
• nervousness

Talk to your doctor if you or your child have side effects that are bothersome or do not go away.

These are not all the possible side effects of Adderall®.

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 Adderall®?

• Store Adderall® at room temperature between 68° to 77°F (20° to 25°C).
• Protect Adderall® from light.
• Store Adderall® in a safe place, like a locked cabinet.
• Dispose of remaining, unused, or expired Adderall® 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 Adderall® 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 Adderall® in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Keep Adderall® and all medicines out of the reach of children.

General information about the safe and effective use of Adderall®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Adderall® for a condition for which it was not prescribed. Do not give Adderall® 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 Adderall® that is written for healthcare professionals.

What are the ingredients in Adderall®?

Active Ingredient: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate.

Inactive Ingredients: colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium.  The 5 mg is a white to off-white tablet, which contains no color additives.  The 7.5 mg and 10 mg also contain FD&C Blue #1 Aluminum Lake as a color additive. The 12.5 mg, 15 mg, 20 mg and 30 mg also contain FD&C Yellow #6 Aluminum Lake as a color additive.

Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054

For more information about Adderall®, please contact Teva at 1-888-838-2872.