Focalin XR, Focalin

Dexmethylphenidate Extended-Release Capsules

(dex METH il FEN i date)

Focalin XR

This drug has a risk of abuse and misuse. Use this drug only as you were told by your doctor. Tell your doctor if you have ever abused or been addicted to any drugs or alcohol.

It is used to treat attention deficit problems with hyperactivity. It may be given to you for other reasons. Talk with the doctor.

If you have an allergy to dexmethylphenidate, methylphenidate, or any other part of this drug. If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. 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 any of these health problems: Glaucoma, agitation, anxiety, or overactive thyroid. If you have ever had a stroke. If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen. If you are taking any of these drugs: Linezolid or methylene blue. This is not a list of all drugs or health problems that interact with this drug. 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 drug 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 drug. 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 drug affects you. If you have been taking this drug for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this drug stops working well. Do not take more than ordered. You may need to have some heart tests before starting this drug. If you have questions, talk with your doctor. This drug may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this drug. This drug may cause high blood pressure. Check blood pressure and heart rate as the doctor has told you. Heart attacks, strokes, and sudden deaths have happened in adults taking this drug. Sudden deaths have also happened in children with some heart problems or heart defects. Call your doctor right away if you have a fast, slow, or abnormal heartbeat; weakness on 1 side of the body; 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 severe dizziness or passing out. If you are taking this drug and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and some natural products or aids. Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this drug may cause nervousness, shakiness, and a fast heartbeat. Avoid drinking alcohol while taking this drug. A severe and sometimes deadly problem called serotonin syndrome may happen if you take this drug with 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; severe diarrhea, upset stomach, or throwing up; or severe headache. Rarely, low blood cell counts have happened with this drug. Call your doctor right away if you have any unexplained bruising or bleeding; signs of infection like fever, chills, or sore throat; or feel very tired or weak. This drug 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 drug 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight. 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. Joint pain. Purple patches on the skin or mouth. Change in eyesight. Seizures. Shakiness. Trouble controlling body movements. Sweating a lot. Restlessness. 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. Change in sex interest. 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 drug. Tell your doctor if you or a family member have any mental or mood problems like depression or bipolar illness, or if a family member has committed suicide. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like depression, thoughts of suicide, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Dizziness. Feeling sleepy. Feeling nervous and excitable. Stomach pain or heartburn. Headache. Weight loss. Not hungry. Trouble sleeping. Dry mouth. Upset stomach or throwing up. Throat pain. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take with or without food. If taken with food, this drug may take longer to work. Take this drug early in the day to prevent sleep problems. Swallow whole. Do not chew or crush. If you cannot swallow this drug whole, you may sprinkle the contents on applesauce. If you do this, swallow the mixture right away without chewing.

Skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.

Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom. Store this drug in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep this drug safe. Keep all drugs away from pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

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. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.