Concerta

What is Concerta?

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

Concerta is used to treat attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD). It is indicated for use in children 6 years of age and older, adolescents, and adults up to the age of 65. Concerta should be used as an integral part of a treatment program that includes psychological, educational, and social measures.

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

Important information

You should not use Concerta if you have glaucoma, tics or Tourette's syndrome, or severe anxiety, tension, or agitation.

Do not use Concerta if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Concerta may be habit forming. Never share methylphenidate with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Before taking this medicine

Do not use Concerta if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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

• glaucoma;

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

• severe anxiety, tension, or agitation (methylphenidate can make these symptoms worse).

Tell your doctor if you have any heart problems. Some stimulants have caused sudden death in people with serious heart problems or congenital heart defects.

Tell your doctor if you have:

• heart disease, heart rhythm disorder;

• coronary artery disease (hardened arteries); or

• history of heart attack.

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

• high blood pressure;

• a personal or family history of mental illness, psychotic disorder, bipolar illness, depression, or suicide attempt;

• peripheral vascular disease such as Raynaud's syndrome;

• epilepsy or other seizure disorder;

• tics (muscle twitches) or Tourette's syndrome;

• a stomach disorder; or

• a history of drug or alcohol addiction.

Concerta may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction.

FDA pregnancy category C. It is not known whether Concerta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

Methylphenidate can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Long-term use of Concerta can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Do not give Concerta to a child younger than 6 years old without a doctor's advice.

How should I take Concerta?

Take Concerta exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Concerta can be taken with or without food.

To prevent sleep problems, take this medication in the morning.

If you need surgery, tell the surgeon ahead of time that you are using Concerta. You may need to stop using the medicine for a short time.

Store Concerta at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Concerta is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is later than 6:00 p.m. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid?

Concerta may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid drinking alcohol. Alcohol may cause methylphenidate to be released into the bloodstream too fast.

Concerta side effects

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

Stop taking Concerta and call your doctor at once if you have:

• new or worsening symptoms such as mood swings, aggression, hostility, or changes in personality or behavior;

• panic, delusion, extreme fear, hallucinations, unusual behavior, motor tics (muscle twitches);

• chest pain, fast or slow heart rate, pounding heartbeats or fluttering in your chest, feeling like you might pass out;

• numbness, pain, unexplained wounds, cold feeling, or skin color changes (pale, red, or blue appearance) in your fingers or toes;

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• easy bruising, purple spots on your skin;

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• penis erection that is painful or lasts 4 hours or longer (rare); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Common Concerta side effects may include:

• feeling nervous or irritable, sleep problems (insomnia);

• loss of appetite, weight loss;

• headache, dizziness, drowsiness; or

• stomach pain, nausea, vomiting, upset stomach.

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.

See also: Side effects (in more detail)

What other drugs will affect Concerta?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Concerta, especially:

• clonidine;

• guanethidine;

• a blood thinner such as warfarin, Coumadin;

• an antidepressant--amitriptyline, citalopram, doxepin, fluoxetine, nortriptyline, paroxetine, sertraline, and others;

• cold or allergy medicine that contains a decongestant;

• medications to treat high or low blood pressure;

• seizure medicine--phenobarbital, phenytoin, primidone; or

• stimulant medications or diet pills.

This list is not complete. Other drugs may interact with Concerta, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.