Methylphenidate is a stimulant medicine used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.

Methylphenidate may also be used for purposes not listed in this medication guide.

You should not use methylphenidate if you are allergic to it, or if you have:

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

Becoming dependent on this medicine during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of methylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine. If you are breastfeeding, tell your doctor if you notice symptoms in the baby such as agitation, sleep problems, feeding problems, or reduced weight gain.

Not approved for use by anyone younger than 6 years old.

• glaucoma;
• severe high blood pressure or a heart problem;
• overactive thyroid;
• a personal or family history of tics (muscle twitches) or Tourette's syndrome; or
• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• blood circulation problems in the hands or feet;
• alcoholism or drug addiction; or
• (if you take ) and allergy to aspirin or yellow food dye. Adhansia

• problems with the esophagus, stomach, or intestines; or
• seizures, epilepsy, or an abnormal brain wave test (EEG).

Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you also use opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with methylphenidate could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

Also, tell your doctor if you have ever had:

Use Cotempla XR-ODT (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have hives; difficulty breathing; swelling of your face, lips, tongue, or throat. signs of an allergic reaction:

Call your doctor at once if you have:

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Methylphenidate can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer.

• sweating, increased blood pressure;
• mood changes, anxiety, feeling nervous or irritable, trouble sleeping;
• fast heart rate, pounding heartbeats or fluttering in your chest;
• loss of appetite, weight loss;
• dry mouth, nausea, vomiting, stomach pain, indigestion; or
• headache, dizziness.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.