Methylphenidate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat attention deficit hyperactivity disorder (ADHD). Take it exactly as directed.
• Keep all appointments for checkups to see how this medicine affects you.
• This medicine may cause serious or life-threatening heart problems, or new or worsening mental or behavioral symptoms. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: stimulant

Generic and brand names: methylphenidate, oral; Concerta; Metadate CD; Metadate ER; Methylin; Methylin ER; QuilliChew ER; Quillivant XR; Ritalin; Ritalin LA; Ritalin-SR

What is this medicine used for?

This medicine is taken by mouth to treat attention deficit hyperactivity disorder (ADHD) in children and adults. It may be used along with therapy and education to treat this condition. This medicine is also used to treat narcolepsy (the uncontrollable need to sleep).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you or members of your family have ever had:

• An allergic reaction to any medicine
• Problems with alcohol or drug abuse
• Epilepsy, tics, Tourette syndrome, or other seizure disorder
• Glaucoma
• Heart attack, heart problems, or a heart defect
• High blood pressure
• Mental health problems such as anxiety, schizophrenia, depression or bipolar disorder
• Peripheral neuropathy (numbness, tingling, pain, or burning feelings in your feet or hands)
• Phenylketonuria (PKU). The chewable tablet contains phenylalanine.
• Problems with your digestive system
• Seizures
• Thyroid problems

Tell your provider if you have taken an MAO inhibitor antidepressant in the past 2 weeks.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Do not take the medicine for any other conditions without your healthcare provider's approval.

Check the label on the medicine for directions about your specific dose. Take it exactly as prescribed. Do not take more or less or take it longer than prescribed. Taking too much of this medicine can be habit-forming.

Check with your healthcare provider before using this medicine in children under age 6.

This medicine comes in different forms. Do not break, crush, or chew the extended-release tablets or capsules. Swallow them whole. Your pharmacist can tell you if you have the extended-release tablets or capsules and when you should take them.

If you have trouble swallowing, the capsule may be opened and the beads sprinkled on cold applesauce. Do not chew or crush beads.

Always take the chewable tablet with a full (8 ounce) glass of water, milk, or juice. Taking the chewable tablet without enough liquid may cause choking. Take the chewable tablet in the morning. If you take the regular chewable tablet, take the last dose of the day no later than 6 PM to avoid interrupting your sleep at night. If you take QuilliChew ER, take it only once per day in the morning.

If you have the liquid form of this medicine, shake it well before using. Use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct.

Your healthcare provider may ask you to stop taking this medicine for a while to see if you still need to take it. However, do not stop taking this medicine without your healthcare provider's approval. You may have to gradually reduce your dosage.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: vomiting, restlessness, tremors, twitching, seizures, confusion, hallucinations, sweating, fast or pounding heartbeat, blurred vision, dry mouth or nose, fainting.

What should I watch out for?

Your healthcare provider should check blood pressure and heart rate regularly during treatment with this medicine. Call your healthcare provider right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking this medicine.

Call your healthcare provider right away if you notice any new or worsening mental symptoms or problems while taking this medicine, especially:

• More outgoing or aggressive behavior than normal
• Hallucinations (seeing or hearing things that are not real)
• Psychosis (believing things that are not real)
• Paranoia (unusually suspicious)

Do not drink alcohol while taking this medicine. Alcohol causes this medicine to be absorbed too quickly.

This medicine is a controlled substance. It is illegal to give this medicine to anyone else.

Do not use this medicine for normal tiredness or as a stimulant. It can be habit-forming.

This medicine should be given by an adult when prescribed for a child. This medicine may slow growth in children. Talk to your healthcare provider about this.

Some forms of this medicine may not completely dissolve when you take them. You may see tablet shells in your bowel movement. This is normal and not a cause for concern.

Rarely, this medicine may cause problems with the blood vessels in your fingers or toes. Contact your healthcare provider right away if your fingers or toes feel numb, cool, painful, or change color from pale, to blue, to red, or if you have unexplained wounds or sores on your hands or feet while taking this medicine.

Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If you have an erection lasting more than 4 hours, get medical care right away. It can lead to permanent erectile dysfunction if not treated.

This medicine may cause blurred vision or dizziness. Do not drive or operate machinery unless you are fully alert and can see clearly.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); seizures (may be followed by coma); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): New or worsening mood or behavior changes; chest pain; fainting; joint pain; fast or irregular heartbeat; unusual or ongoing muscle pain, tenderness, or weakness, especially if you also have a fever or unusual tiredness; yellowing of your skin or eyes; light-colored bowel movements; dark urine; rapid weight loss; severe rash; blistering or peeling skin; hallucinations (seeing or hearing things that are not there); sweating; numbness; pain; or skin color changes in fingers or toes; unexplained sores on fingers or toes.

Other: Loss of appetite, nervousness, dizziness, drowsiness, headache, nausea, trouble sleeping, stomach pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Allergy, cold, or cough medicines that contain phenylephrine (Neo-Synephrine, Sudafed PE) or pseudoephedrine (Sudafed)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antacids that contain aluminum or magnesium, such as Gaviscon, Maalox, and Mylanta
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), and sertraline (Zoloft)
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), pimozide (Orap), and thioridazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Atomoxetine (Strattera)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Caffeine
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Clonidine (Catapres, Kapvay)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), torsemide (Demadex), triamterene (Dyrenium), and triamterene/hydrochlorothiazide (Dyazide, Maxzide)
• Doxepin (Silenor)
• Ephedrine
• Epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen)
• Linezolid (Zyvox)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and ranitidine (Zantac)
• Medicines to treat breathing or lung problems such as albuterol (ProAir, Proventil, Ventolin), aminophylline, arformoterol (Brovana), fluticasone/salmeterol (Advair), formoterol (Perforomist), metaproterenol, mometasone/formoterol (Dulera), salmeterol (Serevent), terbutaline, and theophylline
• Natural remedies such as ephedra, guarana, St. John's wort, and yohimbe
• Other stimulants and diet pills such as armodafinil (Nuvigil), benzphetamine (Regimex), dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), diethylpropion (Tenuate), doxapram (Dopram), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), modafinil (Provigil), phendimetrazine, and phentermine (Adipex-P, Suprenza)
• Parkinson’s disease medicines such as apomorphine (Apokyn), bromocriptine (Cycloset, Parlodel), levodopa/carbidopa (Duopa, Rytary, Sinemet), pramipexole (Mirapex), and ropinirole (Requip)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rasagiline (Azilect)
• Warfarin (Coumadin)

Do not drink alcohol while taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.