Generic Name: METHYLPHENIDATE - ORAL
Pronounced: (meth-ill-FEN-eh-date)

Ritalin Oral Warning

Misuse or abuse of methylphenidate may result in serious (possibly fatal) heart and blood pressure problems.

Methylphenidate should be given cautiously to emotionally unstable patients, especially if there is a history of alcohol or drug abuse. These patients may be more likely to unnecessarily increase their doses or take this medication too often. Long-term overuse of this medication may lead to reduced drug effect, drug dependence, and abnormal behavior.

Take this medication only by mouth. Serious mental/mood changes (e.g., psychosis) may occur, especially if this drug is abused.

If methylphenidate must be stopped, it should be stopped gradually over time. Follow your doctor's instructions on how to gradually lower the dose. In some patients, long-term monitoring may be required after the medication is stopped.

Ritalin Oral Side Effects

Headache, stomach pain, loss of appetite, trouble sleeping, dizziness, nausea, vomiting, lightheadedness, irritability, nervousness, blurred vision, dry mouth, constipation or (rarely) drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• uncontrolled movements (motor tics or tremor)
• verbal tics (e.g., Tourette's syndrome)
• weight loss
• fast/pounding/irregular heartbeat
• mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, abnormal thoughts)
• difficulty urinating

Tell your doctor immediately if any of these rare but very serious side effects occur:

• signs of infection (e.g., fever, persistent sore throat)
• easy bruising/bleeding

Seek immediate medical attention if any of these rare but very serious side effects occur:

• shortness of breath
• chest pain
• jaw/left arm pain
• fainting
• seizures
• sudden vision changes
• weakness on one side of the body
• slurred speech
• confusion

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Ritalin Oral Precautions

Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

• severe anxiety/tension
• certain mental/mood conditions (e.g, agitation, psychosis)
• heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy)
• problems with heart structure (e.g., valve problems)
• history of heart attack or stroke
• glaucoma
• motor tics

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• high blood pressure (hypertension)
• family history of sudden death/irregular heartbeat/rhythm
• family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts)
• overactive thyroid (hyperthyroidism)
• seizures
• verbal tics (diagnosis or family history of Tourette's syndrome)

This drug may make you dizzy, lightheaded, (rarely) drowsy, or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Though uncommon, depression itself can lead to thoughts or attempts of suicide. If you are being treated for depression, tell your doctor immediately if you have any suicidal thoughts, or other mental/mood changes. Keep all medical appointments so your doctor can monitor your progress closely.

Children younger than 6 years may be at greater risk for the side effects of this medication.

This drug may affect your child's growth rate, weight, and final adult height, especially in children younger than 6 years. To reduce the risk, the doctor may recommend temporarily stopping the medication from time to time. Check your child's weight and height, and consult your doctor or pharmacist for more details.

Methylphenidate should be used during pregnancy only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if methylphenidate passes into breast milk. Consult your doctor before breast-feeding.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.