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DYANAVEL® XR SIDE EFFECTS AND SAFETY INFORMATION

The most serious risk information to know about DYANAVEL® XR

DYANAVEL XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DYANAVEL XR in a safe place to prevent misuse and abuse. Selling or giving away DYANAVEL XR may harm others and is against the law. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines, or street drugs.
DYANAVEL XR should not be taken if you or your child are allergic to amphetamine, or any of the ingredients in DYANAVEL XR, or are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.

Serious side effects to know about DYANAVEL XR

The following have been reported with the use of amphetamine and other stimulant medicines:

  • 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
  • Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with DYANAVEL XR
  • Mental (psychiatric) problems:
  • New or worse behavior and thought problems
  • New or worse bipolar illness
  • May cause new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon):
  • Fingers or toes may feel numb, cool, painful, or may change color from pale, to blue, to red

Call your healthcare provider right away if you or your child have any:

  • Heart-related symptoms such as chest pain, shortness of breath, or fainting
  • New or worsening mental (psychiatric) symptoms or new manic symptoms
  • Signs of unexplained wounds appearing on fingers or toes while taking DYANAVEL XR
  • Symptoms of serotonin syndrome:
  • Agitation, hallucinations, coma, or changes in mental status; problems controlling movements or muscle twitching, stiffness, or tightness; fast heartbeat; sweating or fever; nausea, vomiting or diarrhea. Call your doctor or go to the emergency room if symptoms occur. Serotonin syndrome may occur if DYANAVEL XR is taken with certain medicines and may be life-threatening
  • Slowing of growth (height and weight) in children:
  • Your child should have his or her height and weight checked often while taking DYANAVEL XR for Attention-Deficit/Hyperactivity Disorder (ADHD). The doctor may stop treatment if a problem is found during these check-ups.

Children should have their height and weight checked often while taking DYANAVEL XR. DYANAVEL XR treatment may be stopped if a problem is found during check-ups.

Who should not take DYANAVEL XR

DYANAVEL® XR (amphetamine) should not be taken if you or your child:
  • Are allergic to amphetamine, or any of the ingredients in DYANAVEL XR. See the end of the Medication Guide for a complete list of ingredients in DYANAVEL XR
  • Are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor, or MAOI

If you or your child have other health conditions...

DYANAVEL® XR (amphetamine) may not be right for you or your child. Before starting DYANAVEL XR tell your or your child’s healthcare provider 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 and toes
  • Are pregnant or plan to become pregnant. It is not known if DYANAVEL XR will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
  • Are breastfeeding or plan to breastfeed. DYANAVEL XR passes into your breast milk. You and your healthcare provider should decide if you will take DYANAVEL XR or breastfeed

If you or your child are taking other medications...

Tell your healthcare provider about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. DYANAVEL® XR (amphetamine) 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 DYANAVEL XR.

Your healthcare provider will decide whether DYANAVEL XR can be taken with other medicines.

Especially tell your healthcare provider if you or your child takes:
  • Antidepression medicines including MAOIs
  • Cold or allergy medicines that contain decongestants
  • Know the medicines that you or your child takes. Keep a list of your medicines with you to show your healthcare provider and pharmacist
Do not start any new medicine while taking DYANAVEL XR without talking to your healthcare provider first.

Additional information you should know about DYANAVEL XR

  • Your healthcare provider may often ask you to stop taking DYANAVEL XR for some time to check your ADHD symptoms
  • Your healthcare provider may check your blood, heart, and blood pressure while you are taking DYANAVEL XR
  • Children should have their height and weight checked often. If a problem is found, your healthcare provider may ask you to stop taking DYANAVEL XR
  • In case of poisoning, immediately call 1-800-222-1222, or go to the nearest hospital emergency room
  • If you miss a dose of DYANAVEL XR, be sure to speak with your healthcare provider

Possible side effects of DYANAVEL XR

  • Painful and prolonged erections, known as priapism, have occurred with methylphenidate. If they occur, seek medical help right away. Because priapism can cause lasting damage, it should be checked by a healthcare provider right away
  • The most common side effects of DYANAVEL XR include decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, fast heart beat, increased blood pressure
  • These are not all the possible side effects of DYANAVEL XR

Call your healthcare provider for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

For more information about the possible side effects of DYANAVEL XR, see full Prescribing Information.

Important Safety Information & Approved Use

DYANAVEL XR, Quillivant XR, and QuilliChew ER are federally controlled substances (CII) because they can be abused or lead to dependence. Keep these medicines in a safe place to prevent misuse and abuse. Selling or giving away these medicines may harm others and is against the law. Tell your doctor if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

See Additional Important Safety Information.