CONCERTA Oral

Warnings 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.

Uses Methylphenidate is used to treat attention disorders (attention deficit hyperactivity disorder, or ADHD) as part of a total treatment plan including psychological, educational and social measures. When used to treat ADHD, patients may find they have increased attention, decreased impulsiveness, and decreased hyperactivity (see also Notes section). This medication is a mild stimulant that works by affecting the levels of chemicals (neurotransmitters) in the nervous system. This medication should not be used to treat simple fatigue symptoms.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used in patients who have narcolepsy (a disorder of sleep regulation) or be used in combination with other medications to treat certain mood disorders (certain cases of depression).

How to use CONCERTA Oral Read the Medication Guide provided by your pharmacist before you start using methylphenidate and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth, once daily in the morning, with or without food, or as directed by your doctor. Swallow this medication whole with a full glass of liquid (e.g., water, milk, juice). Do not crush, chew, or break the tablets; doing so can destroy the long action of the drug and may increase side effects. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. It may take up to two weeks to notice an improvement while on this drug. Use this medication exactly as prescribed. Dosage is based on your medical condition and response to therapy. Your doctor may instruct you to gradually increase or decrease your dose. Do not increase your dose, use it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for a long period of time, do not suddenly stop using this without first consulting your doctor. This medication may cause dependence, especially if it has been used regularly for an extended period of time, or if it has been used in high doses. In such cases, if you suddenly stop this drug, withdrawal reactions may occur. Such reactions can include severe depression and chronic overactivity. Report to your doctor immediately any such reactions. When stopping extended, regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details. Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted. When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. Inform your doctor if your condition persists or worsens.

Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. 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/heart disease (e.g., heart failure, recent heart attack, abnormal heart rhythm), overactive thyroid (hyperthyroidism), family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), seizures, esophagus/stomach/intestine problems (e.g., narrowing of the gut, gut motility disorders), verbal tics (diagnosis or family history of Tourette's syndrome). This drug may make you dizzy, lightheaded, (rarely) drowsy or cause blurred vision; use caution engaging in activities requiring alertness or clear vision such as driving or using machinery. Limit alcoholic beverages. Before having surgery, tell your doctor or dentist that you are taking this medication. The tablet shells may be visible on an X-ray. Make sure X-ray personnel know that you use this drug. 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. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Overdose If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: confusion, agitation, sweating, flushing, wide pupils, persistent tremor, muscle twitching, hallucinations, severe headache, severe vomiting, seizures, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law. Laboratory and/or medical tests (e.g., blood pressure, growth monitoring in children requiring long-term therapy) should be performed periodically to monitor your progress or check for side effects. Other laboratory tests (blood counts, platelets) may also be performed to check for side effects. Consult your doctor for more details. Methylphenidate may help lessen inattention and hyperactivity ADHD symptoms such as not paying attention, making careless mistakes, not listening, being easily distracted, fidgeting, talking excessively, or interrupting others. There are different brands and forms of this medication available. Not all have identical effects. Do not change brands or forms without consulting your doctor or pharmacist.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the US product in a safe place at room temperature 77 degrees F (25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Store the Canadian product in a safe place at room temperature between 59-86 degrees F (15-30 degrees C). Store away from moisture and sunlight. Do not store in the bathroom. Keep all medicines away from children and pets. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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.
Inactive parts of this drug may be passed in your stool as a harmless soft mass that may look like the original tablet. This is normal for this drug.
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, blurred vision, 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, 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.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks before or after treatment with this medication. In some cases, a serious, possibly fatal, drug interaction may occur. If you are currently using any of these medications, tell your doctor or pharmacist before starting this medication. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), clonidine, guanethidine, phenylbutazone, drugs that can increase blood pressure (e.g., phenylephrine), anti-seizure drugs (e.g., phenobarbital, phenytoin, primidone), tricyclic antidepressants (e.g., imipramine, desipramine), SSRI antidepressants (e.g., fluoxetine, sertraline). Also report the use of drugs which might increase seizure risk when combined with this medication such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details. Check the labels on all your medicines/herbal products (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure (e.g., pseudoephedrine, phenylephrine, ephedra/ma huang). Ask your pharmacist about the safe use of these products. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.