Serdexmethylphenidate and Dexmethylphenidate

IMPORTANT WARNING:

The combination of serdexmethylphenidate and dexmethylphenidate can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor. If you take too much serdexmethylphenidate and dexmethylphenidate, you may continue to feel a need to take large amounts of the medication, and you may experience unusual changes in your behavior. You or your caregiver should tell your doctor immediately if you experience any of the following symptoms: fast, pounding, or irregular heartbeat; sweating; dilated pupils; abnormally excited mood; restlessness; irritability; difficulty falling sleeping or staying asleep; hostility; aggression; anxiety; loss of appetite; loss of coordination; uncontrollable movement of a part of the body; flushed skin; vomiting; stomach pain; or thinking about harming or killing oneself or others or planning or trying to do so.

Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications.

Do not stop taking serdexmethylphenidate and dexmethylphenidate without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression and extreme tiredness if you suddenly stop taking serdexmethylphenidate and dexmethylphenidate after overusing it. Your doctor may need to monitor you carefully after you stop taking serdexmethylphenidate and dexmethylphenidate, even if you have not overused the medication, because your symptoms may worsen when treatment is stopped.

Do not sell, give away, or let anyone else take your medication. Selling or giving away serdexmethylphenidate and dexmethylphenidate may harm others and is against the law. Store serdexmethylphenidate and dexmethylphenidate in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many capsules are left so you will know if any are missing.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with serdexmethylphenidate and dexmethylphenidate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

The combination of serdexmethylphenidate and dexmethylphenidate is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children 6 years of age and older. The combination of serdexmethylphenidate and dexmethylphenidate is in a class of medications called central nervous system stimulants. These medications work by changing the amounts of certain natural substances in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of serdexmethylphenidate and dexmethylphenidate comes as a capsule to take by mouth. It is usually taken once daily in the morning with or without food. Take serdexmethylphenidate and dexmethylphenidate at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take serdexmethylphenidate and dexmethylphenidate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not chew or crush them. If you are unable to swallow the capsule, you may open the capsule and sprinkle the entire contents into about 2 oz (50 mL) of water or onto 2 teaspoonsful of applesauce. Swallow or eat this mixture right away within 10 minutes of mixing. Do not store the medication mixture for future use.

Your doctor will probably start you on a low dose of serdexmethylphenidate and dexmethylphenidate and increase your dose gradually, not more often than once every week.

Your condition should improve during your treatment. Call your doctor if your symptoms worsen at any time during your treatment or do not improve after 1 month.

What SPECIAL PRECAUTIONS should I follow?

Before taking serdexmethylphenidate and dexmethylphenidate,

• tell your doctor and pharmacist if you are allergic to serdexmethylphenidate, methylphenidate, dexmethylphenidate, any other medications, or any of the ingredients in serdexmethylphenidate and dexmethylphenidate capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).

• some medications should not be taken with serdexmethylphenidate and dexmethylphenidate. Other medications may cause dosing changes or extra monitoring when taken with serdexmethylphenidate and dexmethylphenidate. Make sure you have discussed any medications you are currently taking or plan to take before starting serdexmethylphenidate and dexmethylphenidate with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking serdexmethylphenidate and dexmethylphenidate, please get the advice of your doctor or pharmacist.

• tell your doctor if anyone in your family has or has ever had an irregular heartbeat or has died suddenly. Also tell your doctor if you have recently had a heart attack and if you have or have ever had a heart defect, high blood pressure, an irregular heartbeat, hardening of the arteries, heart or blood vessel disease, or other heart problems. Your doctor will examine you to see if your heart and blood vessels are healthy. Your doctor will probably tell you not to take serdexmethylphenidate and dexmethylphenidate if you have a heart condition or if there is a high risk that you may develop a heart condition.

• tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), or has thought about or attempted suicide. Also tell your doctor if you have or have ever had mental illness, or circulation problems in your fingers or toes.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking serdexmethylphenidate and dexmethylphenidate, call your doctor.

• tell your doctor if you are breastfeeding. If you breastfeed while taking serdexmethylphenidate and dexmethylphenidate, monitor the breastfed infant carefully for agitation, weight loss, or poor feeding. Call your doctor immediately if the breastfed infant has any of these symptoms.

• you should know that serdexmethylphenidate and dexmethylphenidate should be used as part of a total treatment program for ADHD, which may include counseling and special education. Make sure to follow all of your doctor's and/or therapist's instructions.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Serdexmethylphenidate and dexmethylphenidate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weight loss
• nausea
• heartburn
• dizziness

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• rash
• hives
• itching
• depression
• believing things that are not true
• feeling unusually suspicious of others
• hallucinating (seeing things or hearing voices that do not exist)
• mania (frenzied or abnormally excited mood)
• paleness or blue color of fingers or toes
• pain, numbness, burning, or tingling in the hands or feet
• unexplained wounds appearing on fingers or toes
• blistering or peeling skin
• frequent, painful erections
• erection that lasts longer than 4 hours

Serdexmethylphenidate and dexmethylphenidate may cause sudden death in children and teenagers, especially children or teenagers with heart defects or serious heart problems. This medication also may cause sudden death, heart attack or stroke in adults, especially adults with heart defects or serious heart problems. Call your doctor right away if you or your child has any signs of heart problems while taking this medication including: chest pain, shortness of breath, or fainting. Talk to your doctor about the risks of taking this medication.

Serdexmethylphenidate and dexmethylphenidate may slow children's growth or weight gain. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is taking this medication. Talk to your child's doctor about the risks of giving serdexmethylphenidate and dexmethylphenidate to your child.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• vomiting
• diarrhea
• restlessness
• anxiety
• agitation
• tremors
• muscle twitching
• convulsions
• intense happiness
• confusion
• hallucinating (seeing things or hearing voices that do not exist)
• delirium
• sweating
• flushing
• headache
• fever
• fast or irregular heartbeat
• dilated pupils
• blurred vision
• muscle pain and weakness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood pressure and heart rate and order certain lab tests to check your body's response to serdexmethylphenidate and dexmethylphenidate.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.