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METHYLPHENIDATE SUSTAINED-ACTION TABLET-ORAL (cont.)

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 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, chest pain, mental/mood changes, 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. 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. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: 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/agitation, glaucoma, motor tics. Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure (hypertension), heart disease (e.g., heart failure, recent heart attack, abnormal heart rhythm), overactive thyroid (hyperthyroidism), other mental/mood conditions (e.g., psychosis, severe depression), seizures, 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. 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. Prolonged use of stimulants like methylphenidate could possibly hinder growth (weight gain and height) in children. Monitor your child's height and growth rate regularly. 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.




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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