Ingredient Name: METHYLPHENIDATE (meth-ill-FEN-i-date)
Drug Manufacturer: MALLINCKRODT PHARM
Common Uses: This medicine is a central nervous system (CNS) stimulant used to treat attention-deficit disorder (ADD) and uncontrollable periods of daytime sleep (narcolepsy). It may also be used to treat other conditions as determined by your doctor.
Before Using This Medicine: WARNING: USE THIS MEDICINE WITH CAUTION IF YOU HAVE A HISTORY OF EMOTIONAL PROBLEMS, OR ALCOHOL OR SUBSTANCE ABUSE. Abuse of this medicine may cause it to not work as well. Abuse may also lead to addiction and severe mental changes. Do not suddenly stop using this medicine. Depression and other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it. SOME MEDICINES MAY INTERACT with this medicine. DO NOT TAKE THIS MEDICINE if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days. TELL YOUR HEALTH CARE PROVIDER if you are taking any other medicines, especially any of the following: clonidine, anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), tricyclic antidepressants (eg, imipramine), or medicines for high blood pressure (eg, guanethidine, metoprolol). This may not be a complete list of all interactions that may occur. Ask your health care provider if this medicine may interact with other medicines you take. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of seizures or abnormal electroencephalograms (EEGs); overactive thyroid; chronic fatigue; cystic fibrosis; stomach or bowel problems (eg, blockage, inflammation, narrowing); allergies; pregnancy; or breast-feeding. Tell your doctor if you have a history of high blood pressure, heart problems (eg, heart failure, fast or irregular heartbeat), or a recent heart attack, or if a family member has a history of irregular heartbeat or sudden death. Tell your doctor if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension); abnormal thoughts; hallucinations; suicidal thoughts or attempts; alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe anxiety, agitation, or tension; glaucoma; serious heart problems (eg, heart defect, irregular heartbeat); or motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome. Use of this medicine in children under age 6 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE by mouth 30 to 45 minutes before eating unless otherwise directed by your doctor. YOU MAY EXPERIENCE trouble sleeping while taking this medicine. If this occurs, taking your last dose before 6 p.m. may help. Talk with your doctor if your sleeping problems continue. DO NOT CHANGE the way you take this medicine without talking with your doctor first. STORE THIS MEDICINE at room temperature, at 77 degrees (25 degrees C), away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Cautions: DO NOT TAKE THIS MEDICINE if you are allergic to it or to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. If using this medicine for an extended period of time, DO NOT SUDDENLY STOP taking this medicine without your doctor's approval. When used for an extended period of time, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well. Laboratory and/or medical tests, including heart function, liver function, blood pressure, complete blood counts, and platelet counts may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. SERIOUS EFFECTS including heart attack, stroke and sudden death have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious heart problem, talk with your doctor about other therapies to treat your condition. This medicine may cause drowsiness or dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. CHECK WITH YOUR DOCTOR before drinking alcohol while taking this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. THIS MEDICINE MAY AFFECT growth rate and weight gain in children and teenagers. They may need regular growth and weight checks while taking this medicine. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN because they may be more sensitive to the effects of the medicine especially loss of appetite, stomach pain, trouble sleeping and fast heartbeat. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast-milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are taking this medicine, check with your doctor or pharmacist to discuss the risks to your baby.
Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include: dizziness; drowsiness; headache; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping. If they continue or are bothersome, check with your doctor. SEEK MEDICAL ATTENTION RIGHT AWAY if any of these SEVERE side effects occur: behavior changes (eg, aggression, hostility, restlessness); blurred vision or other vision problems; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, anxiety, depression, irritability, panic attacks, persistent crying, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; tremor; uncontrolled speech or muscle movements; yellowing of the eyes or skin. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; joint pain; purple or brownish red spots on the skin. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include confusion; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; muscle twitching; seizures; severe or persistent headache; tremors; unusual sweating; vomiting.
Additional Information: If your symptoms do not improve within 1 month or if they become worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.