Adhansia XR

What is Adhansia XR?

Adhansia XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Adhansia XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if Adhansia XR is safe and effective in children under 6 years of age.

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

What is the most important information I should know about Adhansia XR?

Adhansia XR can cause serious side effects, including:

• Abuse and dependence. Adhansia XR, other methylphenidate containing medicines, and amphetamines 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 Adhansia XR.
  • 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 children 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 treatment with Adhansia XR. Tell your healthcare provider if you or your child have any heart problems, heart defects, high blood pressure, or have a family history of these problems.
    
    Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with Adhansia XR.
    
    Call your healthcare provider 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 Adhansia XR.
• 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 Adhansia XR, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

Who should not take Adhansia XR?

Do not take Adhansia XR if you or your child are:

• allergic to methylphenidate hydrochloride or any of the ingredients in Adhansia XR. See the end of this Medication Guide for a complete list of ingredients in Adhansia XR.
• taking, or have stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

What should I tell my healthcare provider before taking Adhansia XR?

Before taking Adhansia XR tell 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
• are pregnant or plan to become pregnant. It is not known if Adhansia XR will harm the unborn baby.
  • There is a pregnancy registry for females who are exposed to Adhansia XR during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Adhansia XR and their baby. If you or your child becomes pregnant during treatment with Adhansia XR, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.
• are breastfeeding or plan to breastfeed. Adhansia XR passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Adhansia XR.

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.

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

Especially tell your healthcare provider if you or your child take a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Know the medicines that you or your child take. Keep a list of the medicines with you to show your healthcare provider and pharmacist. Do not start any new medicine during treatment with Adhansia XR without talking to your healthcare provider first.

How should I take Adhansia XR?

• Take Adhansia XR exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose if needed.
• Take Adhansia XR by mouth 1 time each day in the morning.
• Adhansia XR can be taken with or without food, but take it the same way each time.
  • Swallow Adhansia XR capsules whole. If Adhansia XR capsules cannot be swallowed whole, the capsules may be opened and sprinkled onto a tablespoonful of applesauce or yogurt. Make sure to sprinkle all the medicine onto the applesauce or yogurt. The Adhansia XR dose should not be divided.
    • swallow all the applesauce or yogurt and medicine mixture without chewing right away or within 10 minutes
    • do not chew the applesauce or yogurt
    • do not store applesauce or yogurt and medicine mixture
• Your healthcare provider may sometimes stop Adhansia XR treatment for a while to check ADHD symptoms.
• If a dose of Adhansia XR is missed do not take the dose later in the day or take an extra dose to make up for the missed dose, wait until the next morning to take the next scheduled dose.

In case of poisoning call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking Adhansia XR?

Avoid drinking alcohol during treatment with Adhansia XR. This may cause a faster release of the Adhansia XR medicine.

What are the possible side effects of Adhansia XR?

Adhansia XR can cause serious side effects, including:

• See “What is the most important information I should know about Adhansia XR?”
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.
• 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 or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
  Call your healthcare provider right away if your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Adhansia XR.
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often while taking Adhansia XR. Adhansia XR treatment may be stopped if your child is not growing or gaining weight.
• FD&C Yellow No. 5. Adhansia XR 45 mg capsules contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.

The most common side effects in adults include trouble sleeping, dry mouth, and decreased appetite.
The most common side effects of Adhansia XR in children include decreased appetite, trouble sleeping, and decreased weight.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Adhansia XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Adhansia XR for a condition for which it was not prescribed. Do not give Adhansia XR to other people, even if they have the same symptoms. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about Adhansia XR that was written for healthcare professionals.

How should I store Adhansia XR?

• Store Adhansia XR at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Adhansia XR in a safe place, like a locked cabinet. Protect from light and moisture.
• Dispose of remaining, unused, or expired Adhansia XR by a medication 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 Adhansia XR 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 Adhansia XR in the household trash.

Keep Adhansia XR and all medicines out of the reach of children.

What are the ingredients in Adhansia XR?

Active Ingredient: methylphenidate hydrochloride

Inactive Ingredients: ammonio methacrylate copolymer dispersion (type B), anionic copolymer (consisting of methyl acrylate, methyl methacrylate and methacrylic acid), glyceryl monostearate, hypromellose, poylethylene glycol, polysorbate, silicon dioxide, sodium hydroxide, sodium laurylsulfate, sorbic acid, sugar spheres, triethyl citrate

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.