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|Methylphenidate Chewable Tablets

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Methylphenidate Chewable Tablets

Generic Name: Methylphenidate Chewable Tablets (meth-ill-FEN-ih-date)
Brand Name: Methylin

Methylphenidate should be given with caution to patients with a history of substance abuse or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with abuse of injections. Careful supervision is required during withdrawal from abusive use because depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Methylphenidate Chewable Tablets is used for:

Treating attention deficit hyperactivity disorder (ADHD) and uncontrollable sleep attacks (narcolepsy). It may also be prescribed for other conditions as determined by your doctor.

Methylphenidate Chewable Tablets is a central nervous system stimulant. It works by blocking 2 chemicals in the brain. The exact way Methylphenidate Chewable Tablets works is unknown.

Do NOT use Methylphenidate Chewable Tablets if:

you are allergic to any ingredient in Methylphenidate Chewable Tablets
you have severe anxiety, agitation, or tension
you have glaucoma
you have motor tics, Tourette syndrome, or a family history of Tourette syndrome
you are currently taking or have taken a monoamine oxidase (MAO) (eg, phenelzine) inhibitor in the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Methylphenidate Chewable Tablets:

Some medical conditions may interact with Methylphenidate Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of bizarre behavior, mood swings, fatigue, agitation, anxiety, tension, depression, psychosis, or abnormal thoughts or visions
if you have a history of seizures, convulsions, or abnormal electroencephalograms (EEGs)
if you have difficulty swallowing
if you have high blood pressure, have had a recent heart attack, or have other heart problems
if you have high thyroid hormone levels or a history of substance abuse or alcoholism
if you have phenylketonuria

Some MEDICINES MAY INTERACT with Methylphenidate Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Guanethidine because the effectiveness may be decreased by Methylphenidate Chewable Tablets
MAO inhibitors (eg, phenelzine) because the actions and side effects of Methylphenidate Chewable Tablets may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methylphenidate Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Methylphenidate Chewable Tablets:

Use Methylphenidate Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Methylphenidate Chewable Tablets comes with an additional patient leaflet. Read it carefully.
Methylphenidate Chewable Tablets should be taken, preferably 30 to 45 minutes before meals, with at least 8 ounces of liquid to prevent choking.
If you miss a dose of Methylphenidate Chewable Tablets and you take one dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Methylphenidate Chewable Tablets.

Important safety information:

Methylphenidate Chewable Tablets may cause dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Methylphenidate Chewable Tablets. Using Methylphenidate Chewable Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
If choking, chest pain, vomiting, or difficulty breathing occurs after taking Methylphenidate Chewable Tablets, seek medical attention immediately.
Methylphenidate Chewable Tablets should not be used to treat depression or prevent or treat normal tiredness.
Do not drink alcohol while taking Methylphenidate Chewable Tablets.
There have been very rare reports of neuroleptic malignant syndrome (NMS). It is uncertain whether these cases were caused by Methylphenidate Chewable Tablets alone or by some other combination factors. Notify your doctor if you experience fever, excessive sweating, shortness of breath, inability to control bladder, muscle rigidity, tremors, or unusual muscle movements.
Phenylketonuria patients - Methylphenidate Chewable Tablets contains phenylalanine.
LAB TESTS, such as complete blood cell counts and platelet counts, may be needed to monitor for side effects. Keep all doctor and laboratory appointments.
Methylphenidate Chewable Tablets may reduce weight gain or growth in CHILDREN. Your health care provider will watch weight and height carefully. Your doctor may stop treatment if growing or gaining weight are not as your doctor expects. Contact your health care provider if you do not see improvement in symptoms within 1 month. Methylphenidate Chewable Tablets is not recommended for use in CHILDREN younger than 6 years of age; safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Methylphenidate Chewable Tablets during pregnancy. It is unknown if Methylphenidate Chewable Tablets is excreted in breast milk. If you are or will be breast-feeding while using Methylphenidate Chewable Tablets, contact your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, Methylphenidate Chewable Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Methylphenidate Chewable Tablets stops working well. Do not take more than prescribed.

Abuse of Methylphenidate Chewable Tablets can lead to DEPENDENCE. Tell your doctor or health care provider if you have ever abused or had dependence on alcohol or drugs, or if you are now abusing or dependent on alcohol or substances.

Possible side effects of Methylphenidate Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased appetite (more severe in children); diarrhea; dizziness; drowsiness; dry mouth; fever; hair loss; headache; itching; joint pain; loss of appetite; nervousness; sleeplessness; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bruising; changes in heart rate (fast or slow); changes in mood or personality; chest pain or pounding in the chest; confusion; convulsions or seizures; depression; involuntary muscle movements; joint pain; psychosis (abnormal thinking or hallucinations, hearing abnormal sounds); seizures; sore throat and fever; vision changes or blurred vision; weight loss; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include dilated pupils; fast heartbeat; flushing; hallucinations; loss of consciousness; muscle twitching; nervousness; seizures; severe or persistent headache; sweating; tremors; twitching; vomiting.

Proper storage of Methylphenidate Chewable Tablets:

Store Methylphenidate Chewable Tablets between 68 and 77 degrees (20 and 25 degrees C) away from heat, moisture, and light. Do not store in the bathroom. Keep Methylphenidate Chewable Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Methylphenidate Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
Methylphenidate Chewable Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Methylphenidate Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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