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

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

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Metadate ER may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Call your doctor right away if you have: signs of heart problems--chest pain, feeling light-headed or short of breath; or signs of psychosis--paranoia, aggression, new behavior problems, seeing or hearing things that are not real.

Metadate ER may be habit-forming. Tell your doctor if you have a history of drug or alcohol addiction. Keep the medication where others cannot get to it.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Metadate ER may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

Most brands of methylphenidate are taken 1 or 2 times during the day. Jornay PM is for use only at night between 6:30 and 9:30 pm.

You may take Metadate ER with or without food, but take it the same way each time.

Swallow the extended-release capsule or tablet whole and do not crush, chew, or break it.

If you cannot swallow an extended-release capsule whole, open it and mix the medicine with soft food such as applesauce, pudding or yogurt. Swallow the mixture right away without chewing.

You must chew the chewable tablet before you swallow it.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Allow the orally disintegrating tablet to dissolve in your mouth without chewing.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often.

Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

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

• 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).

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

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

Do not use Metadate ER 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 Metadate ER could cause a serious condition called serotonin syndrome.

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

• 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 Adhansia) and allergy to aspirin or yellow food dye.

Also, tell your doctor if you have ever had:

• problems with the esophagus, stomach, or intestines; or

• seizures, epilepsy, or an abnormal brain wave test (EEG).

Becoming dependent on Metadate ER 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.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Metadate ER could be fatal.

Overdose symptoms may include nausea, dry mouth, vomiting, diarrhea, anxiety, agitation, restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.

Avoid drinking alcohol.

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

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

Metadate ER may cause serious side effects. Call your doctor at once if you have:

• 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.

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.

Metadate ER 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.

Common side effects of Metadate ER may include:

• 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.

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.

Tell your doctor about all your other medicines, especially:

• a blood thinner--warfarin, Coumadin, Jantoven;

• blood pressure medication;

• an antidepressant;

• seizure medication; or

• cold or allergy medications that contain decongestants.

This list is not complete. Other drugs may affect Metadate ER, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.