Apo-Methylphenidate: Uses, Side Effects and Dosage

Serious warnings and precautions box

What APO-METHYLPHENIDATE is used for:

APO-METHYLPHENIDATE is used in children 6 years of age and older, adolescents and adults to treat:

• narcolepsy (a type of sleep disorder). This disorder causes excessive sleepiness during the day and frequent and uncontrollable episodes of falling asleep.
• Attention Deficit Hyperactivity Disorder (ADHD). Treatment with APO-METHYLPHENIDATE should be combined with other measures such as psychological counselling, educational and social measures, as part of a total treatment program.

APO-METHYLPHENIDATE is NOT recommended for use in children under 6 years of age.

How APO-METHYLPHENIDATE works:

APO-METHYLPHENIDATE belongs to a group of medicines called central nervous system stimulants. It is thought to work by raising the levels of chemicals in the brain called dopamine and norepinephrine. This helps to:

• increase alertness and wakefulness in patients with narcolepsy
• increase attention and decrease impulsiveness and hyperactivity in patients with ADHD

The ingredients in APO-METHYLPHENIDATE are:

Medicinal ingredient: Methylphenidate hydrochloride

Non-medicinal ingredients: 5 mg tablet: anhydrous lactose, magnesium stearate, sunset yellow aluminum lake 40%.

Abuse, misuse, and addiction

Like other stimulants, APO-METHYLPHENIDATE has the potential to be abused and misused. This can lead to you developing a substance use disorder, also known as addiction.

Misusing APO-METHYLPHENIDATE may cause serious heart problems and even sudden death.

10 mg tablet: anhydrous lactose, D&C Yellow #10, FD&C Blue #1, magnesium stearate.

20 mg tablet: anhydrous lactose, D&C Yellow #10, magnesium stearate.

APO-METHYLPHENIDATE comes in the following dosage forms:

Tablets: 5 mg, 10 mg and 20 mg.

Do not use APO-METHYLPHENIDATE if:

• You are allergic to methylphenidate hydrochloride or any of the other ingredients in APO-METHYLPHENIDATE.
• You have ever had heart problems such as a heart attack, irregular heartbeat, chest pain (angina), heart failure, heart disease or were born with a heart problem.
• You have moderate to severe high blood pressure (hypertension) or narrowing of the blood vessels (arterial occlusive disease that can cause pain in the arms and legs).
• You have advanced arteriosclerosis (hardened arteries).
• You have an overactive thyroid gland.
• You have anxiety, tension, or agitation.
• You have increased eye pressure (glaucoma).
• You have or have a family history of, motor tics (hard to control, repeat twitching of any parts of the body), verbal tics (hard to control, repeating of sounds or words) or Tourette’s syndrome.
• You are taking or have recently taken (in the last 14 days) any medications from a group called monoamine oxidase inhibitors.
• You have a tumor of the adrenal gland called pheochromocytoma.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-METHYLPHENIDATE. Talk about any health conditions or problems you may have, including if you:

• Have structural heart abnormalities, cardiomyopathy, serious heart rhythm abnormalities or other serious heart problems.
• Have a family history of sudden death or death related to heart problems.
• Have any other current or previous heart problems.
• Do high intensity exercise or activities.
• Take other stimulant drugs.
• Have a history of drug or alcohol addiction.
• Have had seizures or abnormal EEGs (measure of brainwave activity).
• Have mild high blood pressure.
• Take blood pressure medications.
• Have an abnormal heart rate or rhythm.
• Have or have had any disorder of the blood vessels in the brain such as weakening of blood vessels (aneurysm), stroke, inflammation of blood vessels (vasculitis).
• Have aggressive behaviour, are anxious or agitated, or feel more aggressive, anxious or agitated than usual.

• Have mental problems or have a family history of mental health problems, including:

  • psychosis,
  • mania,
  • bipolar disorder,
  • depression or
  • suicide.
• Are over 60 years of age.

• Are lactose intolerant or have one of the following rare hereditary diseases:

  • Galactose intolerance,
  • Lapp lactase deficiency,
  • Glucose-galactose malabsorption.

Because lactose is a non-medicinal ingredient in APO-METHYLPHENIDATE.

• Are pregnant, think you are pregnant or are planning to become pregnant.

• Are breastfeeding or plan to breastfeed. APO-METHYLPHENIDATE can pass through your breast milk. You should talk to your healthcare professional to determine if you should stop breastfeeding or stop taking APO-METHYLPHENIDATE.

Other warnings you should know about:

Abuse, misuse, and addiction: Like other stimulants, APO-METHYLPHENIDATE has the potential to be abused and misused. This can lead to you developing a substance use disorder, also known as addiction. Even if you take APO-METHYLPHENIDATE as directed by your healthcare professional, you may develop tolerance with long-term treatment. This means that you may need a higher dose of APO-METHYLPHENIDATE to treat your narcolepsy or ADHD. Talk to your healthcare professional:

• if you have a history of drug or alcohol addiction
• if you have questions or concerns about abuse, misuse, addiction, or tolerance

Do not change your dose or stop taking APO-METHYLPHENIDATE without first talking to your healthcare professional. If you stop taking APO-METHYLPHENIDATE, you will need careful supervision because you may feel very depressed.

Heart-related problems: The following heart related problems have been reported in people taking medication to treat ADHD, like APO-METHYLPHENIDATE:

• sudden death in patients who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate

Sudden death has been reported in association with stimulant drugs for ADHD treatment in children with structural heart abnormalities. APO-METHYLPHENIDATE generally should not be used in children, adolescents or adults with known structural heart abnormalities.

Tell your healthcare professional if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your healthcare professional will check:

• you for heart problems before starting APO-METHYLPHENIDATE
• your blood pressure and heart rate regularly during treatment with APO-METHYLPHENIDATE

Seek immediate medical help if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking APO-METHYLPHENIDATE.

Mental health problems: The following mental health problems have been reported in people taking medicine to treat ADHD like APO-METHYLPHENIDATE:

• new or worse thoughts or feelings related to suicide (thinking about or feeling like killing yourself) and suicide actions (including suicide attempt, suicidal ideation and completed suicide)
• new or worse bipolar disorder (extreme mood swings, with periods of impulsiveness or unusual excitement, switching between periods of sadness)
• new or worse aggressive behaviour or hostility
• new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms

These new or worse mental problems may be more likely to occur if you/your child have mental disorders that you may or may not know about. Tell your healthcare professional about any mental problems or about any personal or family history of suicide, bipolar illness, or depression you or your child have.

A small number of patients taking ADHD drugs may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of suicide, self-harm or harm to others. Those suicidal thoughts or behaviors may occur at any time during treatment, particularly at the start or during dose changes, and also after stopping APO-METHYLPHENIDATE. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your healthcare professional immediately. Close observation by a healthcare professional is necessary in this situation.

Serotonin toxicity (also known as serotonin syndrome): Serotonin toxicity is a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take APO-METHYLPHENIDATE with certain antidepressants or migraine medications.

Serotonin toxicity symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma

Raynaud’s Phenomenon: Stimulants used to treat ADHD, such as APO-METHYLPHENIDATE, are associated with Raynaud’s Phenomenon. During treatment with APO-METHYLPHENIDATE, your healthcare professional may check for problems with the circulation in your fingers and toes, including numbness, feeling cold or pain.

Growth in children: Slower growth (weight gain and/or height) has been reported with long-term use of methylphenidate hydrochloride in children. Your healthcare professional will carefully watch your child’s height and weight. If your child is not growing or gaining weight as expected, your healthcare professional may stop treatment.

Driving and using machines: APO-METHYLPHENIDATE may cause dizziness, drowsiness, blurred vision, hallucination or other side effects which can affect concentration. If you feel dizzy, drowsy, have blurred vision or hallucinations do not drive, use machines, or do other activities that require mental alertness or physical coordination.

Testing and check-ups: Your healthcare professional may do tests before you start and during treatment with APO-METHYLPHENIDATE. These tests may include:

• tests that check for problems in the heart or brain
• tests that check your blood pressure and heart rate
• blood tests to check complete blood count, platelet counts and liver enzymes.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious drug interactions:

Serious drug interactions with APO-METHYLPHENIDATE include:

• monoamine oxidase inhibitors (MAOIs). You MUST NOT take APO-METHYLPHENIDATE if you are taking or have recently taken (within the last 14 days) any MAOIs as it may cause serious side effects.
• clonidine, a medicine used to treat high blood pressure. You MUST NOT take APO-METHYLPHENIDATE if you are taking clonidine as it may cause serious side effects, including sudden death.

The following may also interact with APO-METHYLPHENIDATE:

• alcohol.
• medicines used to increase blood pressure.
• medicines used to lower blood pressure.
• other stimulant medications.
• cold and allergy medicines.
• certain medicines used to treat depression, such as tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs).
• certain medicines used to treat migraine.
• certain medicines used to prevent nausea and vomiting.
• certain medicines used to prevent seizures, such as phenobarbital, diphenylhydantoin and primidone.
• medicines used to prevent blood clots (commonly called “blood thinners”), such as warfarin.
• medicines used to treat Parkinson’s disease.
• medicines used to manage psychosis (antipsychotics).
• anesthetics on the day of an operation, as there is a chance of a sudden rise in blood pressure and heart rate during the operation.
• tests used to detect amphetamines, such as testing used in sports. APO-METHYLPHENIDATE may give a false-positive test result.

How to take APO-METHYLPHENIDATE:

• Your healthcare professional will decide on the dose that is right for you. Always follow the directions of your healthcare professional and never change the dose or stop taking APO-METHYLPHENIDATE without first discussing it with your healthcare professional.

• Take APO-METHYLPHENIDATE tablets by mouth with or without food. Taking APO-METHYLPHENIDATE with food may reduce stomach discomfort.

• If you are having trouble sleeping while taking APO-METHYLPHENIDATE, take your last dose

  • before 6 pm.

Usual dose:

Take APO-METHYLPHENIDATE exactly as prescribed. Your healthcare professional may adjust the dose until it is right for you. From time to time, your healthcare professional may interrupt your treatment to check your symptoms while you are not taking the medicine.

Overdose:

The symptoms of overdose include:

• vomiting,
• agitation,
• headache,
• tremors,
• muscle twitching,
• irregular heart beat,
• flushing,
• fever,
• sweating,
• dilated pupils,
• difficulty breathing,
• confusion,
• hallucinations,
• seizures,
• high blood pressure,
• muscle spasms, red-brown coloured urine which could be possible signs of abnormal breakdown of muscles (rhabdomyolysis).

If you think you, or a person you are caring for, have taken too much APO-METHYLPHENIDATE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If you miss a dose, take it as soon as possible. Take the remaining doses for that day at regularly spaced times. Do not take a double dose to make up for the missed dose.

Possible side effects from using APO-METHYLPHENIDATE:

These are not all the possible side effects you may have when taking APO-METHYLPHENIDATE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• decreased appetite
• decreased weight
• feeling nervous or jittery
• difficulty in falling asleep and staying asleep
• stomach pain, nausea, vomiting
• dry mouth
• difficulty opening the mouth (trismus)
• excessive sweating
• muscle or joint pain
• headache
• dizziness
• tiredness or sleepiness
• trembling
• swelling of the breasts in boys or men
• bedwetting in children during the night (enuresis)
• obsessive-compulsive disorder
• double vision
• dilated pupils
• nosebleed

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Protect APO-METHYLPHENIDATE from moisture and heat. Store between 15°C-30°C.

Do not take APO-METHYLPHENIDATE after the expiry date shown on the package label. Remember to take back unused medicine to your pharmacist.

Keep out of reach and sight of children.

If you want more information about APO-METHYLPHENIDATE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Date of Authorization: 2026-07-03