What is the most important information I should know about methylphenidate?

•

Use caution when driving, operating machinery, or performing other hazardous activities. Methylphenidate may cause dizziness, drowsiness, blurred vision, or impair your ability to concentrate. If you experience dizziness, drowsiness, blurred vision, or impaired concentration, avoid these activities.

•

Do not crush, chew, or break the sustained- or extended-release formulations of methylphenidate (Ritalin SR, Ritalin LA, Metadate ER, Metadate CD, Methylin ER, Concerta). Swallow these whole with water or another beverage. They are specially formulated to release medication slowly in the body. Alternatively, the Ritalin LA and Metadate CD capsules may be opened and the contents sprinkled onto a tablespoon of applesauce (not warm), and the mixture swallowed immediately. Do not save the mixture for later use. The capsule contents should be swallowed whole and not crushed or chewed.

What is methylphenidate?

•

Methylphenidate is a mild stimulant to the central nervous system (brain and nerves). The exact way that methylphenidate works is unknown.

•

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

•

Methylphenidate may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking methylphenidate?

•

Do not take methylphenidate if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

•

Do not take methylphenidate without first talking to your doctor if you have

     ·

an allergy to methylphenidate;

     ·

severe tension, agitation, or anxiety;

     ·

glaucoma;

     ·

motor tics or have been diagnosed with Tourette's syndrome;

     ·

depression;

     ·

a psychotic condition such as schizophrenia;

     ·

epilepsy or another seizure disorder;

     ·

high blood pressure (hypertension);

     ·

a history of alcohol or drug abuse; or

     ·

a narrowing or blockage of your gastrointestinal tract (esophagus, stomach, or intestines).

•

You may not be able to take methylphenidate, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

•

Methylphenidate is in the FDA pregnancy category C. This means that it is not known whether methylphenidate will be harmful to an unborn baby. Do not take methylphenidate without first talking to your doctor if you are pregnant or could become pregnant during treatment.

•

It is not known whether methylphenidate passes into breast milk. Do not take methylphenidate without first talking to your doctor if you are breast-feeding a baby.

How should I take methylphenidate?

•

Take methylphenidate exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain the instructions to you.

•

Take each dose with a full glass (8 ounces) of water.

•

Take each dose of Ritalin or Methylin 30 to 45 minutes before a meal.

•

The sustained-release forms of methylphenidate (Ritalin-SR, Metadate ER, Metadate CD, Methylin ER, Concerta) can be taken with or without food.

•

Do not crush, chew, or break the sustained- or extended-release formulations of methylphenidate (Ritalin SR, Ritalin LA, Metadate ER, Metadate CD, Methylin ER, Concerta). Swallow these whole with water or another beverage. They are specially formulated to release medication slowly in the body. Alternatively, the Ritalin LA and Metadate CD capsules may be opened and the contents sprinkled onto a tablespoon of applesauce (not warm), and the mixture swallowed immediately. Do not save the mixture for later use. The capsule contents should be swallowed whole and not crushed or chewed.

•

If you are taking Concerta, do not be alarmed if you see in your stool what looks like a tablet. This is the outer shell of the tablet, the medication has been absorbed by your body.

•

Store methylphenidate at room temperature away from moisture and heat.

What happens if I miss a dose?

•

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly schedule dose unless otherwise directed by your doctor. Do not take a double dose of this medication.

What happens if I overdose?

•

Seek emergency medical attention.

•

Symptoms of a methylphenidate overdose include agitation, tremors (shaking), muscle twitches, seizures, confusion, hallucinations, sweating, flushing, headache, fast or irregular heartbeat, large pupils, and dryness of the mouth and eyes.

What should I avoid while taking methylphenidate?

•

Use caution when driving, operating machinery, or performing other hazardous activities. Methylphenidate may cause dizziness, drowsiness, blurred vision, or impair your ability to concentrate. If you experience dizziness, drowsiness, blurred vision, or impaired concentration, avoid these activities.

What are the possible side effects of methylphenidate?

•

If you experience any of the following serious side effects, stop taking methylphenidate and seek emergency medical attention or contact your doctor immediately:

     ·

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

     ·

an irregular or fast heartbeat;

     ·

chest pains or very high blood pressure (blurred vision, severe headache, flushing);

     ·

unusual behavior or confusion; or

     ·

liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).

•

Other, less serious side effects may be more likely to occur. Continue to take methylphenidate and talk to your doctor if you experience

     ·

insomnia (difficulty sleeping);

     ·

nervousness;

     ·

drowsiness;

     ·

dizziness;

     ·

headache;

     ·

blurred vision;

     ·

tics (repetitive movements);

     ·

abdominal pain, nausea, or vomiting;

     ·

decreased appetite or weight loss; or

     ·

slower weight gain and/ or growth.

•

Methylphenidate may cause drug dependence.

•

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect methylphenidate?

•

Do not take methylphenidate if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

•

Before taking methylphenidate, tell your doctor if you are taking any of the following medicines:

     ·

warfarin (Coumadin);

     ·

phenytoin (Dilantin);

     ·

phenobarbital (Luminal, Solfoton);

     ·

primidone (Mysoline);

     ·

a tricyclic antidepressant such as nortriptyline (Pamelor), amitriptyline (Elavil, Endep), doxepin (Sinequan), desipramine (Norpramin), clomipramine (Anafranil), or imipramine (Tofranil);

     ·

a selective serotonin reuptake inhibitor such as fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft);

     ·

clonidine (Catapres); or

     ·

guanethidine (Ismelin).

•

You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

•

Drugs other than those listed here may also interact with methylphenidate. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

•

Your pharmacist has more information about methylphenidate written for health professionals that you may read.

•

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.