Methylphenidate Extended-Release Oral-Disintegrating Tablets

• If you have an allergy to methylphenidate or any other part of this medicine (methylphenidate extended-release oral-disintegrating tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
• If you or a family member have any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette's syndrome or tics.
• If you have ever had any of these health problems: Drug abuse or stroke.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Famotidine, omeprazole, or sodium bicarbonate.

This is not a list of all drugs or health problems that interact with this medicine (methylphenidate extended-release oral-disintegrating tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine (methylphenidate extended-release oral-disintegrating tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Heart attacks, strokes, and sudden deaths have happened in adults taking this medicine (methylphenidate extended-release oral-disintegrating tablets). Sudden deaths have also happened in children with very bad heart problems or heart defects. Call your doctor right away if you have a change in strength on 1 side that is greater than the other, trouble speaking or thinking, change in balance, drooping on 1 side of the face, change in eyesight, chest pain or pressure, shortness of breath, or very bad dizziness or passing out.
• You may have some heart tests before starting this medicine. Talk with your doctor.
• If you have seizures, talk with your doctor.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• Avoid drinking alcohol while taking this medicine (methylphenidate extended-release oral-disintegrating tablets).
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (methylphenidate extended-release oral-disintegrating tablets) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Joint pain.
• Purple patches on the skin or mouth.
• Blurred eyesight.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Very bad headache.
• Very upset stomach or throwing up.
• Seizures.
• Fever or chills.
• Sore throat.
• Shakiness.
• Trouble controlling body movements.
• Sweating a lot.
• Feeling very tired or weak.
• Change in color of hands or feet from pale to blue or red.
• Numbness, pain, tingling, or cold feeling of the hands or feet.
• Any sores or wounds on the fingers or toes.
• Not able to pass urine or change in how much urine is passed.
• Muscle pain or weakness.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
• New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this medicine (methylphenidate extended-release oral-disintegrating tablets). Tell your doctor if you or a family member have any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (methylphenidate extended-release oral-disintegrating tablets) is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017