Methylphenidate (meth-il-FEN-i-date)

Treats ADHD.

Brand Name(s):

Aptensio XR, Metadate CD, Ritalin LA

When This Medicine Should Not Be Used:

How to Use This Medicine:

Immediate/Long Acting 30/70 Capsule, Immediate/Long Acting 40/60 Capsule, Immediate/Long Acting 50/50 Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Extended-release capsule:
  • Aptensio XR™ or Ritalin LA®: Take your medicine in the morning before breakfast. Swallow it whole with water or other liquid. If you cannot swallow the capsule whole, you may open it and mix the medicine with a tablespoon of applesauce. Swallow this mixture right away, and then drink some water. Do not chew or crush the mixture.
• If you take the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• Use only the brand of medicine your doctor prescribed. Other brands may not work the same way.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Drop off any unused medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) within the past 14 days.
• Some medicines can affect how methylphenidate works. The specific medicines and foods of concern are different for different brands of methylphenidate. Tell your doctor if you are using any of the following:
  • Guanethidine, phenylbutazone
  • Antacid or other stomach medicine (including esomeprazole, famotidine, omeprazole, pantoprazole, sodium bicarbonate)
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • Halogenated anesthetic medicine
  • Medicine to treat depression (including clomipramine, desipramine, imipramine)
  • Medicine to treat seizures (including phenobarbital, phenytoin, primidone)
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart or blood vessel disease, heart rhythm problems, high blood pressure, circulation problems, phenylketonuria, thyroid problems, asthma, or a history of seizures, heart attack, or stroke. Tell your doctor if you or anyone in your family has a history of depression, suicide, bipolar disorder, mental health problems, or drug or alcohol abuse.
• This medicine may cause the following problems:
  • Serious heart or blood vessel problems, including heart attack and stroke (especially in people who already have heart problems)
  • High blood pressure
  • Prolonged and painful erection
  • Peripheral vasculopathy (a blood circulation problem), including Raynaud's phenomenon
  • Slow growth and weight loss in children
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may make you dizzy or cause blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• If you need surgery, tell the doctor who treats you that you are using this medicine. Medicines used during surgery can increase your blood pressure when used with this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or vision changes
• Chest pain that may spread, trouble breathing, nausea, unusual sweating
• Extreme energy or restlessness, confusion, agitation, unusual moods or behaviors
• Fast, slow, pounding, or uneven heartbeat
• Lightheadedness, dizziness, fainting
• Numb, cold, pale, or painful fingers or toes
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Painful erection or an erection that lasts longer than 4 hours
• Seeing, hearing, or feeling things that are not there
• Seizures
• Slow growth or weight loss in children

If you notice these less serious side effects, talk with your doctor:

• Dry mouth, nausea, stomach pain
• Loss of appetite, weight loss
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088