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

Methylphenidate controlled 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 6 years of age and older, adolescents, and adults who have been diagnosed with ADHD.

Other measures (e.g., psychological, educational, and social therapies) are used along with methylphenidate controlled 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 the ones 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?

10 mg
Each controlled release capsule with white body and light turquoise blue cap, imprinted with "Biphentin" and "10 mg", contains methylphenidate HCl 10 mg. Nonmedicinal ingredients: gelatin, hydroxypropyl methylcellulose, methyl acrylic acid copolymer, polyethylene glycol, sugar beads, talc, and triethyl citrate; capsule shell: FD&C Blue No. 1 and titanium dioxide.

15 mg
Each controlled release capsule with white body and orange cap, imprinted with "Biphentin" and "15 mg", contains methylphenidate HCl 15 mg. Nonmedicinal ingredients: gelatin, hydroxypropyl methylcellulose, methyl acrylic acid copolymer, polyethylene glycol, sugar beads, talc, and triethyl citrate; capsule shell: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, and titanium dioxide.

20 mg
Each controlled release capsule with white body and yellow cap, imprinted with "Biphentin" and "20 mg", contains methylphenidate HCl 20 mg. Nonmedicinal ingredients: gelatin, hydroxypropyl methylcellulose, methyl acrylic acid copolymer, polyethylene glycol, sugar beads, talc, and triethyl citrate; capsule shell: D&C Red No. 33, D&C Yellow No. 10, and titanium dioxide.

30 mg
Each controlled release capsule with white body and blue violet cap, imprinted with "Biphentin" and "30 mg", contains methylphenidate HCl 30 mg. Nonmedicinal ingredients: gelatin, hydroxypropyl methylcellulose, methyl acrylic acid copolymer, polyethylene glycol, sugar beads, talc, and triethyl citrate; capsule shell: FD&C Blue No. 1, FD&C Red No. 3, and titanium dioxide.

40 mg
Each controlled release capsule with white body and pink cap, imprinted with "Biphentin" and "40 mg", contains methylphenidate HCl 40 reg. Nonmedicinal ingredients: gelatin, hydroxypropyl methylcellulose, methyl acrylic acid copolymer, polyethylene glycol, sugar beads, talc, and triethyl citrate; capsule shell: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, and titanium dioxide.

50 mg
Each controlled release capsule with white body and light green cap, imprinted with "Biphentin" and "50 mg", contains methylphenidate HCl 50 mg. Nonmedicinal ingredients: gelatin, hydroxypropyl methylcellulose, methyl acrylic acid copolymer, polyethylene glycol, sugar beads, talc, and triethyl citrate; capsule shell: D&C Yellow No. 10, FD&C Green No. 3, and titanium dioxide.

60 mg
Each controlled release capsule with white body and iron grey cap, imprinted with "Biphentin" and "60 mg", contains methylphenidate HCl 60 mg. Nonmedicinal ingredients: gelatin, hydroxypropyl methylcellulose, methyl acrylic acid copolymer, polyethylene glycol, sugar beads, talc, and triethyl citrate; capsule shell: Black Iron oxide and titanium dioxide.

80 mg
Each controlled release capsule with white body and reddish orange cap, imprinted with "Biphentin" and "80 mg", contains methylphenidate HCl 80 mg. Nonmedicinal ingredients: gelatin, hydroxypropyl methylcellulose, methyl acrylic acid copolymer, polyethylene glycol, sugar beads, talc, and triethyl citrate; capsule shell: FD&C Red No. 40, FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.

How should I use this medication?

The dose of methylphenidate controlled release is determined according to the needs of the person taking the medication. The dose is usually started low and increased gradually at weekly intervals.

For people who are not already taking methylphenidate, the usual starting dose is 10 - 20 mg once daily in the morning, at breakfast.

For people already taking methylphenidate controlled release, the starting dose depends on the dose being taken. The maximum dose is 60 mg daily for children 6 years and older and 80 mg daily for adults.

Swallow this medication whole with water or other liquids. Do not crush or chew the capsules. This medication is designed to be released into the body over time. When the contents of the capsule are crushed, the medication is released into the body faster than it should be and may cause serious side effects.

If desired, the capsule may be opened and the contents of the capsule (the medication) may be sprinkled onto apple sauce, ice cream, or yogurt.

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 controlled 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 (arteriosclerosis)
  • 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
  • headache
  • loss of appetite
  • nausea
  • stomach pain
  • trouble sleeping
  • weight loss

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 if any of the following side effects occur:

  • abnormal thoughts or behaviour
  • aggressive or hostile behavior
  • blurred vision
  • confusion
  • hallucinations (hearing, seeing, or feeling things that are not actually there)
  • muscle twitching or tics
  • sudden high fever
  • symptoms of Raynaud’s Phenomenon (e.g., discolouration of the fingers and toes, pain, sensation of cold and/or numbness)
  • 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)
  • vomiting

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

  • convulsions (seizures)
  • long-lasting, painful erection (4 hours or longer)
  • 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)
  • suicidal thoughts or behavour

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 using 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 use this medication.

HEALTH CANADA ADVISORY

April 21, 2015

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

A previous advisory on methylphenidate controlled 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, aggression, hallucinations, and symptoms of depression 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 controlled 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 might be appropriate for you or your child. Do not stop this medication without discussing it with your doctor first.

Exercise: People participating in strenuous exercise or activities should consult their doctor before taking methylphenidate controlled 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. 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 controlled 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.

Prolonged Erections: Rarely, prolonged and painful erections (called priapism) have been reported by patients using methylphenidate. Priapism is a very rare condition that can affect children as well as adults. It may occur after increasing the dose or stopping the medication for a short period of time.

Patients who develop priapism should seek immediate medical attention to prevent potential long-term effects on the penis.

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.

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 this medication 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.

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, and whether any special monitoring is needed.

Vision: Rarely, people taking methylphenidate controlled 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 controlled 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 and should not be used by children less than 6 years of age.

What other drugs could interact with this medication?

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

  • alcohol
  • alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • alpha agonists (e.g., clonidine, methyldopa)
  • amphetamines (e.g., dextroamphetamine, lisdextroamphetamine)
  • angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
  • 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
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • fast acting bronchodilators (e.g., salbutamol, terbutaline)
  • long acting bronchodilators (e.g., formoterol, salmeterol)
  • caffeine
  • carbamazepine
  • decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
  • decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
  • dipivefrin
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • dobutamine
  • dopamine
  • epinephrine
  • fosphenytoin
  • guanfacine
  • H2-antagonists (e.g., famotidine, ranitidine)
  • methyldopa
  • methylphenidate
  • monoamine oxidase (MAO) inhibitors (e.g., moclobemide, phenelzine, selegiline, tranylcypromine)
  • norepinephrine
  • phenobarbital
  • phenytoin
  • primidone
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • pseudoephedrine
  • theophylline (e.g., aminophylline, oxtriphylline, theophylline)
  • tricyclic antidepressants (e.g., amitriptyline, imipramine, nortriptyline)
  • 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. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications 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.