Relexxii is used to treat attention deficit hyperactivity disorder (ADHD) in people who are at least 6 years old.

Some brands of methylphenidate extended-release tablet can only be used to treat attention deficit disorder in adults under 65 years old and children at least 6 years old.

Some brands of Relexxii are also used in the treatment of a sleep disorder called narcolepsy.

Relexxii 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.

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

Call your doctor right away if you have: chest pain, feeling light-headed, seeing or hearing things that are not real, decreased need for sleep, being agitated, unexplained wounds on your fingers or toes.

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.

Relexxii may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away Relexxii 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 to 3 times during the day. Jornay PM is for use only in the evening. Do not use this medicine more often than prescribed.

Take with a full glass of water.

You may take Relexxii with or without food, but take it the same way each time. Some brands of methylphenidate need to be taken 30 to 45 minutes before a meal.

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

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

Part of an extended release tablet shell may appear in your stool but this will not make the medicine less effective.

You must chew the chewable tablet before you swallow it.

Shake the oral suspension (liquid) for at least 10 seconds. Measure liquid medicine (solution or suspension) with the supplied measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package with dry hands only when you are ready to use the medicine. Allow the orally disintegrating tablet to dissolve in your mouth without chewing.

Tell your doctor if you have a planned surgery.

Your doctor will need to check your progress on a regular basis and you may need medical tests to check your heart function. Tell any doctor who treats you that you are using this medicine.

Your treatment may also include counseling or other treatments.

Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. 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.

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

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

• glaucoma;

• a personal or family history of tics (muscle twitches) or Tourette's syndrome;

• trouble swallowing, problems with the stomach, or intestines;

• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse);

• an inability to digest certain types of sugar; or

• if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

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

• heart problems or defects;

• high blood pressure; or

• a family history of heart disease or sudden death.

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 fingers or toes or peripheral vascular disease such as Raynaud's syndrome;

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

• phenylketonuria;

• alcoholism or drug addiction; or

• an allergy to aspirin or yellow food dye (tartrazine).

It is not known if Relexxii will harm an unborn baby. 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 agitation, insomnia, feeding problems, and reduced weight gain in the nursing baby.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. If you take Jornay PM, skip the missed dose and take your next dose at the regular time. 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 Relexxii could be fatal.

Avoid drinking alcohol.

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

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

Stimulants have caused stroke, heart attack, and sudden death in certain people. Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, or feeling short of breath.

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

• signs of heart or blood circulation problems --chest pain, uneven heart rate, trouble breathing, numbness, cold feeling, or pale appearance of your fingers or toes;

• signs of mania or psychosis-- seeing or hearing things that are not real, aggression, paranoia, decreased need for sleep, risk-taking behavior, being agitated or talkative;

• a seizure, muscle twitches (tics), changes in your vision, blurry vision; or

• a painful erection that lasts 4 hours or longer.

Relexxii can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects of Relexxii may include:

• sweating, increased blood pressure;

• mood changes, anxiety, irritability, sleep problems (insomnia);

• restlessness, nervousness;

• fast or uneven heart rate;

• loss of appetite, weight loss;

• dry mouth, nausea, vomiting, stomach pain, upset stomach; 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;

• an antacid;

• an antidepressant;

• seizure medication; or

• cold or allergy medications that contain decongestants.

This list is not complete and many other drugs may affect Relexxii. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.