Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

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

Methylphenidate should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Tell your doctor if you have had problems with drug or alcohol abuse.

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

Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

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

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

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

Tell your doctor if you have a history of drug or alcohol addiction. Keep the medication where others cannot get to it.

Methylphenidate comes as an immediate-release tablet, a chewable tablet, a solution (liquid), a long-acting (extended-release) suspension (liquid), an intermediate-acting (extended-release) tablet, a long-acting (extended-release) capsule, a long-acting (extended-release) tablet, a long-acting (extended-release) chewable tablet, and a long-acting (extended-release) orally disintegrating tablet (tablet that dissolves quickly in the mouth). The long-acting tablet, orally disintegrating tablets, and capsules supply some medication right away and release the remaining amount as a steady dose of medication over a longer time. All of these forms of methylphenidate are taken by mouth. The regular tablets, chewable tablets (Methylin), and solution (Methylin) are usually taken two to three times a day by adults and twice a day by children, preferably 35 to 40 minutes before meals. Adults who are taking three doses should take the last dose before 6:00 pm, so that the medication will not cause difficulty in falling asleep or staying asleep. The intermediate-acting tablets are usually taken once or twice a day, in the morning and sometimes in the early afternoon 30 to 45 minutes before a meal. The long-acting capsule (Metadate CD) is usually taken once a day before breakfast; the long-acting tablet (Concerta), long-acting chewable tablet (Quillichew ER), long-acting suspension (Quillivant XR), and long-acting capsules (Aptensio XR, Ritalin LA) are usually taken once a day in the morning with or without food. The long-acting suspension (Quillivant XR) will begin to work sooner if it is taken with food. The long-acting orally disintegrating tablet (Cotempla XR-ODT) and the long-acting capsule (Adhansia XR) is usually taken once daily in the morning and should be taken consistently, either always with food or always without food. The long-acting capsule (Jornay PM) is usually taken once daily in the evening (between 6:30 pm and 9:30 pm),and should be taken consistently, at the same time every evening and either always with food or always without food.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take methylphenidate exactly as directed.

Do not try to push the extended-release orally disintegrating tablet (Cotempla XR-ODT) through the blister pack foil. Instead, use dry hands to peel back the foil packaging. Immediately take out the tablet and place it in your mouth. The tablet will quickly dissolve and can be swallowed with saliva; no water is needed to swallow the tablet.

You should thoroughly chew the immediate-release chewable tablets and then drink a full glass (at least 8 ounces [240 milliliters]) of water or other liquid. If you take the immediate-release chewable tablet without enough liquid, the tablet may swell and block your throat and may cause you to choke. If you have chest pain, vomiting, or trouble swallowing or breathing after taking the chewable tablet, you should call your doctor or get emergency medical treatment immediately.

Swallow the intermediate-acting and long-acting tablets and capsules whole; do not split, chew, or crush them. However, if you cannot swallow the long-acting capsules (Aptensio XR, Jornay PM, Metadate CD, Ritalin LA), you may carefully open the capsules and sprinkle the entire contents on a tablespoon of cool or room temperature applesauce, or for long-acting capsules (Adhansia XR), you may open the capsules and sprinkle the entire contents on a tablespoon of applesauce or yogurt. Swallow (without chewing) this mixture immediately after preparation (within 10 minutes if taking Adhansia XR) and then drink a glass of water to make sure you have swallowed all of the medicine. Do not store the mixture for future use.

If you are taking the long-acting chewable tablet (Quillichew ER) and your doctor has told you to take part of the tablet to get the correct amount of your dose, break the 20 mg or 30 mg long-acting chewable tablet carefully along the lines that have been scored into it. However, the 40 mg long-acting chewable tablet is not scored and cannot be divided or split.

If you are taking the long-acting suspension (Quillivant XR), follow these steps to measure the dose:

1. Remove the bottle of medication and dosing dispenser from the box. Check to be sure that the bottle contains liquid medication. Call your pharmacist and do not use the medication if the bottle contains powder or if there is no dosing dispenser in the box.
2. Shake the bottle up and down for at least 10 seconds to mix the medication evenly.
3. Remove the bottle cap. Check that the bottle adapter has been inserted into top of the bottle.
4. If the bottle adapter has not been inserted into the top of the bottle, insert it by placing the bottom of the adapter into the opening of the bottle and pressing down firmly on it with your thumb. Call your pharmacist if the box does not contain a bottle adapter. Do not remove the bottle adapter from the bottle once it is inserted.
5. Insert the tip of the dosing dispenser into the bottle adapter and push the plunger all the way down.
6. Turn the bottle upside down.
7. Pull the plunger back to withdraw the amount of oral suspension prescribed by your doctor. If you are not sure how to correctly measure the dose your doctor has prescribed, ask your doctor or pharmacist.
8. Remove the dosing dispenser and slowly squirt the oral suspension directly into your mouth or your child's mouth.
9. Replace the cap on the bottle and close tightly.
10. Clean the dosing dispenser after each use by placing it in the dishwasher or by rinsing with tap water.

Your doctor may start you on a low dose of methylphenidate and gradually increase your dose, 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.

Your doctor may tell you to stop taking methylphenidate from time to time to see if the medication is still needed. Follow these directions carefully.

Some methylphenidate products may not be able to be substituted for another. Ask your pharmacist if you have any questions about the type of methylphenidate product your doctor has prescribed.

Take methylphenidate exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Methylphenidate 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 methylphenidate 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 methylphenidate 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 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:

• 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 - an allergy to aspirin or yellow food dye.

To make sure methylphenidate is safe for you, tell your doctor if you have::

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

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

Becoming dependent on methylphenidate 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.

methylphenidate is 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 methylphenidate 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from light and excess heat and moisture (not in the bathroom). Store methylphenidate in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules or how much liquid is left so you will know if any medication is missing.

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.

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

Avoid drinking alcohol.

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

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

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.

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.

Common methylphenidate side effects 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 interact with methylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

If you are taking methylphenidate long-acting tablets (Concerta), you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.

Keep all appointments with your doctor and the laboratory. Your doctor may check your blood pressure and heart rate and order certain lab tests to check your response to methylphenidate.

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.