How does this medication work? What will it do for me?

Methylphenidate extended release belongs to the family of medications known as stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD). It helps to increase attention and decrease restlessness in children, adolescents, and adults who have been diagnosed with ADHD.

Other measures (e.g., psychological, educational, and social therapies) are used along with methylphenidate extended release as part of an overall treatment program for ADHD.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

18 mg
Each yellow, capsule-shaped, film-coated, extended release tablet, engraved with "N" on one side and "18" on the other side contains methylphenidate hydrochloride 18 mg. Nonmedicinal ingredients: hydroxypropyl methylcellulose, lactose monohydrate, microcrystalline cellulose, polyvinyl alcohol- polyethylene glycol copolymer and colloidal silica, simethicone, stearic acid, D&C Yellow No. 10 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

27 mg
Each grey, capsule-shaped, film-coated, extended release tablet, engraved with "N" on one side and "27" on the other side contains methylphenidate hydrochloride 27 mg. Nonmedicinal ingredients: hydroxypropyl methylcellulose, lactose monohydrate, microcrystalline cellulose, polyvinyl alcohol- polyethylene glycol copolymer and colloidal silica, simethicone, stearic acid, iron oxide black, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

36 mg
Each white to off-white, capsule-shaped, film-coated, extended release tablet, engraved with "N" on one side and "36" on the other side contains methylphenidate hydrochloride 36 mg. Nonmedicinal ingredients: hydroxypropyl methylcellulose, lactose monohydrate, microcrystalline cellulose, polyvinyl alcohol- polyethylene glycol copolymer and colloidal silica, simethicone, stearic acid, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

54 mg
Each brownish-red, capsule-shaped, film-coated, extended release tablet, engraved with "N" on one side and "54" on the other side contains methylphenidate hydrochloride 54 mg. Nonmedicinal ingredients: hydroxypropyl methylcellulose, lactose monohydrate, microcrystalline cellulose, polyvinyl alcohol- polyethylene glycol copolymer and colloidal silica, simethicone, stearic acid, iron oxide yellow, iron oxide red, polyethylene glycol, and titanium dioxide.

How should I use this medication?

The dose of methylphenidate extended release needs to be indvidualized according to the needs of the person taking the medication. The dose is usually started low and increased gradually to the dose that works best for the person.

For people who are not currently taking methylphenidate extended release, the usual starting dose is 18 mg once daily in the morning with or without food.

For people currently taking methylphenidate extended release, the starting dose depends on the current dose being taken. Doses above 72 mg daily are not recommended.

Swallow this medication whole with water or other liquids. Do not crush, chew, or split the tablets. This medication is designed to be released into the body over time. When the tablet is broken, the medication is released into the body faster than it should be and may cause serious side effects.

You may notice the methylphenidate extended release tablet in your stool. If your child is on this medication, you may notice the tablet in your child's stool. This is normal and occurs because the tablet does not completely dissolve after all the medication has been released in the body.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones above, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. Avoid taking this medication late in the day, as it may cause difficulty sleeping. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take methylphenidate extended release if you:

  • are allergic to methylphenidate or any ingredients of the medication
  • are taking a monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine) or have taken one in the last 14 days
  • have advanced hardening of the arteries
  • have anxiety, tension, or agitation
  • have glaucoma (increased pressure in the eye)
  • have heart disease
  • have moderate-to-severe high blood pressure
  • have motor tics, Tourette's syndrome, or a family history of Tourette's syndrome
  • have an overactive thyroid gland

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • agitation, nervousness, or anxiety
  • dizziness
  • drowsiness
  • dry mouth
  • headache
  • joint pain
  • loss of appetite
  • muscle cramps
  • nausea
  • skin rash or itching (mild)
  • stomach pain
  • trouble sleeping
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible any of the following side effects occur:

  • abnormal thoughts or behaviour
  • aggressive or hostile behaviour
  • confusion
  • fever
  • fainting
  • hallucinations (hearing, seeing, or feeling things that are not actually there)
  • increased blood pressure
  • muscle twitching or tics
  • symptoms of depression (e.g., losing interest in your usual activities, feeling sad, having thoughts of suicide)
  • symptoms of mania (e.g., decreased need for sleep, elevated or irritable mood, racing thoughts)
  • symptoms of Raynaud’s Phenomenon (discoloration of fingers and toes, pain, sensation of cold and/or numbness)
  • tics or symptoms of Tourette's syndrome (involuntary, sudden body movements, or uncontrolled vocal outbursts)
  • uncontrolled movements (twitching, jerking)
  • vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • convulsions (seizures)
  • long-lasting (greater than 4 hours) and painful erection of the penis
  • signs of a serious allergic reaction (difficulty breathing; hives; swelling of the face, lips, eyes, mouth, or throat)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
  • sudden signs of heart problems (e.g., fast heartbeat, palpitations, chest pain, shortness of breath, fainting)
  • thoughts of suicide or harming yourself

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

HEALTH CANADA ADVISORY

April 21, 2015

Health Canada has issued new information concerning the use of methylphenidate extended release. To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

A previous advisory on methylphenidate extended release was issued on March 30, 2015. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Behaviour or mood changes: There have been reports of agitation, hallucinations, symptoms of depression, and thoughts of self-harm in people taking this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Blood pressure: This medication can increase blood pressure. If you have high blood pressure or heart problems, talk to your doctor before taking this medication.

Drowsiness/reduced alertness: Methylphenidate extended release may cause dizziness, which could affect your ability to drive or operate machinery. Avoid activities requiring alertness until you have determined how this medication affects you.

Drug dependence: There does not appear to be an increased risk of dependence or addiction with the use of methylphenidate by children and adolescents. However, abuse of methylphenidate is possible by certain individuals. Regular, long-term abuse can lead to high levels of tolerance and psychological dependence, and a wide range of abnormal behaviours. If you have a history of drug or alcohol dependence, you should be closely monitored by your doctor while using this medication.

Drug holidays: It is sometimes helpful to stop methylphenidate to determine whether it is still needed to help the ADHD symptoms. Talk to your doctor about whether a drug holiday (not giving this medication during school holidays) might be appropriate for you or your child. Do not stop this medication without discussing it with your doctor first.

Exercise: If you participate in strenuous exercise or activities, consult your doctor before taking methylphenidate extended release. Strenuous exercise combined with the effects of methylphenidate of the heart and blood pressure may increase the risk of sudden death.

Heart problems and blood pressure: This medication can increase heart rate and blood pressure. It may also increase the risk of sudden death for people with heart problems. This medication should generally not be used by people with known structural heart abnormalities (such as abnormal size, missing or poorly functioning heart valves, or problems with blood vessels connected to the heart) or a family history of sudden or cardiac death. Methylphenidate may also increase the risk of stroke, particularly for people who have already had a stroke or are at risk of having a stroke.

People taking more than one stimulant medication for ADHD should be closely monitored by their doctor.

Misuse of methylphenidate may also be associated with sudden death and other serious heart-related effects.

Long-term use: If you will be using methylphenidate extended release for a long period of time, your doctor will want you to have regular heart checkups, blood pressure checks and lab tests to monitor your liver and blood.

Seizures: There is some evidence that methylphenidate extended release may increase the risk of seizures, particularly for people who have had seizures in the past. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stomach and intestinal problems: This medication should not be used by people with certain stomach or intestinal problems (e.g., narrowing of the intestines, "short gut" syndrome, a history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, or Meckels' diverticulum).

Stopping the medication: Check with your doctor before stopping this medication.

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Suppression of growth: Growth suppression (i.e., less increase in height or weight than usual) has been reported for children using stimulants such as methylphenidate for long periods of time. It is not known if methylphenidate extended release causes growth suppression in children (i.e., less increase in height or weight than usual). Children who need long-term treatment should be carefully monitored for growth. Their doctor may also recommend a "drug holiday," where the medication is not given on weekends or during school holidays.

Tics: This medication may cause tics or worsening of motor or verbal tics. If you have Tourette's syndrome or develop tics while on this medication, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication,

Vision: Rarely, people taking methylphenidate extended release have experienced vision changes. If you notice any changes in your vision, contact your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking methylphenidate extended release, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children less than 6 years of age. Methylphenidate extended release should not be used by children in this age group.

What other drugs could interact with this medication?

There may be an interaction between methylphenidate extended release and any of the following:

  • alcohol
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • antacids (aluminum hydroxide, calcium carbonate, magnesium hydroxide)
  • anti-Parkinson's medications (e.g., bromocriptine, levodopa, pramipexole, ropinirole
  • antipsychotics (e.g., chlorpromazine, haloperidol, quetiapine, risperidone)
  • appetite suppressants (e.g., phentermine)
  • atomoxetine
  • blood pressure-lowering medications
  • caffeine
  • carbamazepine
  • clonidine
  • decongestants (e.g., phenylephrine, pseudoephedrine)
  • dipivefrin
  • epinephrine
  • formoterol
  • fosphenytoin
  • guanfacine
  • indacaterol
  • linezolid
  • H2-antagonists (e.g., famotidine, ranitidine)
  • methyldopa
  • monoamine oxidase (MAO) inhibitors (e.g., moclobemide, phenelzine, selegiline, tranylcypromine)
  • other medications for ADHD
  • phenobarbital
  • phenytoin
  • primidone
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • pseudoephedrine
  • salbutamol
  • salmeterol
  • terbutaline
  • theophylline
  • tricyclic antidepressants (e.g., amitriptyline, imipramine, nortriptyline)
  • xylometazoline
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than the ones listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.