Consumer Information for: APO-METHYLPHENIDATE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


PART III: CONSUMER INFORMATION
 

APO-METHYLPHENIDATE

(Methylphenidate Hydrochloride Tablets USP)

APO-METHYLPHENIDATE SR

(Methylphenidate Hydrochloride Extended-Release Tablets USP)

This leaflet is part III of a three-part “Product Monograph” published when APO-METHYLPHENIDATE / APO-METHYLPHENIDATE SR was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about APO-METHYLPHENIDATE / APO-METHYLPHENIDATE SR. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION

This information for patients or their parents or caregivers is about APO-METHYLPHENIDATE and APO-METHYLPHENIDATE SR, a medication intended for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) or narcolepsy for adults and children over 6 years of age. It is very important that ADHD be accurately diagnosed and that the need for medication be carefully assessed. It is important to remember that APO-METHYLPHENIDATE is only part of the overall management of ADHD. Parents, teachers, healthcare professionals and other professionals are part of a team that must work together.

What the medication is used for:

APO-METHYLPHENIDATE belongs to a group of medicines called central nervous system stimulants. It is used for the treatment of ADHD and narcolepsy. APO-METHYLPHENIDATE tablets contain methylphenidate hydrochloride, the active ingredient in the treatment of ADHD and narcolepsy.

  1.  When used in ADHD, APO-METHYLPHENIDATE improves behaviour by reducing restlessness and increasing attention. APO-METHYLPHENIDATE, however, will not cure ADHD. Treatment with APO-METHYLPHENIDATE or other stimulants should always be combined with other treatment measures, such as psychological counseling and educational tutoring by skilled and experienced therapists.

Children and/or adolescents treated with APO-METHYLPHENIDATE do not seem to become addicted or abuse drugs later in life. However, central nervous stimulants, including APO-METHYLPHENIDATE, should only be given under close medical supervision to patients whose condition has been properly diagnosed.

About ADHD

ADHD is a disorder characterized by symptoms of inattentiveness and/or hyperactivity-impulsivity inappropriate to the patient’s age, which interfere with functioning in two or more settings (e.g., school and home). Symptoms of inattention may include not paying attention, making careless mistakes, not listening, not finishing tasks, not following directions, and being easily distracted. Symptoms of hyperactivity-impulsiveness may include fidgeting, talking excessively, running around at inappropriate times, and interrupting others. Some patients have more symptoms of hyperactivity and impulsiveness while others have more symptoms of inattentiveness. Some patients have both types of symptoms. Symptoms must be present for at least 6 months to be certain of the diagnosis.

  1. When used in narcolepsy, APO-METHYLPHENIDATE may relieve the inappropriate daytime sleepiness; however, many people suffering from narcolepsy need additional treatment aimed at other aspects of this condition.

About Narcolepsy

Persons who suffer from narcolepsy experience attacks of sleepiness during the day although they may have enough sleep at night. These attacks usually occur in unusual situations such as standing, eating or the middle of a conversation. Some people find their head falling forward, jaw dropping, knees buckling or even falling to the ground while they are conscious. These attacks may be brought on by emotional situations such as hearty laughter, excitement, sadness or anger.

What it does:

ADHD

APO-METHYLPHENIDATE works by improving the activity of certain parts of the brain, which are underactive. APO-METHYLPHENIDATE improves attention (attention span) and concentration, and reduces impulsive behaviour.

Narcolepsy

APO-METHYLPHENIDATE relieves excessive daytime sleepiness in patients suffering from narcolepsy.

When it should not be used:

APO-METHYLPHENIDATE or APO-METHYLPHENIDATE SR should not be used if you or your child:

  • 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.

  • 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).

  • Have arteriosclerosis (hardened arteries)

  • Have any thyroid problems

  • Have significant anxiety, tension, or agitation since APO-METHYLPHENIDATE may make these conditions worse.

  • Are allergic to methylphenidate or any of the other ingredients in APO-METHYLPHENIDATE (see What the non-medicinal ingredients are). If you think you may be allergic, talk to your doctor for advice.

  • Have increased eye pressure (glaucoma).

  • Have Tourette’s syndrome, including uncontrolled speech (verbal tics) and body movements (motion tics) or a family history of Tourette’s syndrome.

  • Are taking a medicine called a monoamine oxidase inhibitor (MAOI) used for depression, or have taken an MAOI in the last 14 days (see Interactions with this medication).

  • Have a tumor of the adrenal gland called pheochromocytoma.

What the medicinal ingredient is:

Methylphenidate hydrochloride

What the important non-medicinal ingredients are:

APO-METHLYPHENIDATE 5 mg Tablets: Anhydrous lactose, magnesium stearate and sunset yellow aluminum lake 40%.

APO-METHYLPHENIDATE 10 mg Tablets: Anhydrous lactose, D&C yellow #10, FD&C blue #1 and magnesium stearate.

APO-METHYLPHENIDATE 20 mg Tablets: Anhydrous lactose, D&C yellow #10 and magnesium stearate.

APO-METHYLPHENIDATE SR 20 mg Tablets: Colloidal silicon dioxide, hydroxypropyl methylcellulose and magnesium stearate.

What dosage forms it comes in:

APO-METHYLPHENIDATE tablets are available in 5 mg, 10 mg and 20 mg strengths. APO-METHYLPHENIDATE SR tablets are available in 20 mg strength.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Drug Abuse and Dependence

Abuse of APO-METHYLPHENIDATE can lead to dependence. Tell your doctor if you have ever abused or been dependent on alcohol or drugs, or if you are now abusing or dependent on alcohol or drugs.

The following have been reported with use of methylphenidate hydrochloride and other medicines used to treat ADHD:

1. Heart-related problems:

  • 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 with drugs used for ADHD treatment in children/adolescents with structural heart abnormalities or other serious heart problems. Although some serious heart problems alone can carry an increased risk of sudden death, APO-METHYLPHENIDATE and APO-METHYLPHENIDATE SR generally should not be used in children, adolescents or adults with known structural heart abnormalities or other serious heart disease or conditions.

 

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

Your doctor may wish to check you or your child carefully for heart problems before starting APO-METHYLPHENIDATE.

Your doctor may wish to check your or your child’s blood pressure and heart rate regularly during treatment with APO-METHYLPHENIDATE.

 

Call your doctor right away 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 (Psychiatric) problems:

  • 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 illness, characterized by extreme mood swings, with periods of mania (unusually excited, over-active or un-inhibited) alternating with periods of depression (feelings of sadness, worthlessness or hopelessness)

  • new or worse aggressive behaviour or hostility

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are 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 doctor 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-METHYLPHANIDATE. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking APO-METHYLPHENIDATE, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Tell your doctor immediately if you experience abnormally sustained or frequent and painful erections of the penis on APO-METHYLPHENIDATE treatment or after treatment discontinuation. This can occur in any age group and may need urgent medical treatment.

 

Serotonin toxicity (also known as Serotonin syndrome): APO-METHYLPHENIDATE can cause serotonin toxicity, 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 anti-depressants 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

BEFORE you or your child uses APO-METHYLPHENIDATE talk to your doctor or pharmacist if you or your child:

  • Have structural heart abnormalities.

  • Have a family history of sudden death or death related to heart problems.

  • Have any other current or previous heart problems

  • Do strenuous exercise.

  • Take other stimulant drugs.

  • Have a history of drug or alcohol abuse

  • Have motion tics or if any other family members suffer from tics. Signs of tics that are hard to control, repeated twitching of any parts of the body or repeating sounds and words.

  • Have someone in your family with Tourette’s syndrome.

  • Have had fits (convulsions, epilepsy, seizures) or abnormal EEGs (electroencephalograms).

  • Have mild high blood pressure.

  • Have an abnormal heart rate or rhythm.

  • Have or have had any disorder of the blood vessels in the brain, e.g. weakening of blood vessels (aneurysm), stroke, inflammation of blood vessels (vasculitis).

  • Have aggressive behaviour.

  • Have any suicidal thoughts or behaviour.

  • Have mental problems or family history of mental problems, including psychosis, mania, bipolar illness, depression or suicide.

  • Have circulation problems in fingers and toes, including numbness, feeling cold or pain. (This is also known as Raynaud’s).

  • 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 nonmedicinal ingredient in APO-METHYLPHENIDATE.

Tell your doctor immediately if you develop any of the above conditions or symptoms while taking APO-METHYLPHENIDATE. The doctor will decide if you can start or continue taking APO-METHYLPHENIDATE.

Before taking APO-METHYLPHENIDATE, tell your doctor if you are pregnant or plan for pregnancy (women and men).

 

If you take APO-METHYLPHENIDATE, it can be in your breast milk. Do not breast-feed during your treatment with APO-METHYLPHENIDATE. Tell your doctor if you are nursing a baby. APO-METHYLPHENIDATE may cause dizziness, drowsiness, blurred vision, hallucination or other central nervous system side effects, which can affect concentration. If you experience such symptoms, do not drive or use machines, or do other activities that need quick reactions until you know how this medication affects you.

Monitoring during treatment with APO-METHYLPHENIDATE

To see if APO-METHYLPHENIDATE is having any unwanted effects, the doctor will check from time to time the patient’s health conditions (e.g. blood pressure, heart rate) and will also monitor the growth of children taking APO-METHYLPHENIDATE. Blood tests will be carried out to monitor the amount of blood cells (white blood cells, red blood cells and platelets) if a patient takes APO-METHYLPHENIDATE for a long time.

APO-METHYLPHENIDATE should not be used in children under 6 years of age.

INTERACTIONS WITH THIS MEDICATION

Both your doctor and your pharmacist should also be informed of all medicines you are taking, including herbal medicines or drugs are not taken on a regular basis and are available without prescription.

 

Do not take APO-METHYLPHENIDATE if you are taking

  • A medicine called a monoamine oxidase inhibitor (MAOI, used to treat depression), or have taken an MAOI in the last 14 days. Taking a MAOI with APO-METHYLPHENIDATE may cause a sudden increase in your blood pressure (see When it should not be used).

 

APO-METHYLPHENIDATE may change the way your body reacts to certain medicines. It is important that you tell your doctor or pharmacist if you are taking any of these medicines, it may be necessary to change the dose or in some cases to stop one of the medicines. These include:

  • medicines that increase blood pressure,

  • phenylbutazone (used to treat pain or fever),

  • alpha-2 agonists like clonidine (used to treat high blood pressure),

  • medicines used to treat depression,

  • medicines used to prevent seizures,

  • medicines used to prevent blood clots, e.g. coumarin anticoagulants (commonly called “blood thinners”),

  • medicines that influence the level of dopamine in the body (dopaminergic medicines used to treat Parkinson’s disease or psychosis).,

  • medicines that raise the level of serotonin in the body (serotonergic medicines, for example those used to treat depression like sertraline and venlafaxine).

 

Having an Operation

If you are going to have an operation, tell the doctor that you are on treatment with APO-METHYLPHENIDATE. You should not take APO-METHYLPHENIDATE on the day of your operation if a

certain type of anesthetic is used. This is because there is a chance of a sudden rise in blood pressure and heartbeat during the operation.

 

Taking APO-METHYLPHENIDATE with food and drink

Do not drink alcohol while taking APO-METHYLPHENIDATE. Alcohol may make the side effects of APO-METHYLPHENIDATE worse. Remember that some foods and medicines contain alcohol.

 

Drug testing

APO-METHYLPHENIDATE may give a false positive result when testing for drug use. This includes testing used in sport.

PROPER USE OF THIS MEDICATION
Usual dose:

APO-METHYLPHENIDATE comes in tablets to be taken by mouth. The doctor determines how much and how often you should take APO-METHYLPHENIDATE according to your individual needs. In order for you to receive the most benefits from APO-METHYLPHENIDATE, it is important that APO-METHYLPHENIDATE be taken only as directed by the doctor. Take only the amount of medication at the time intervals and for the time period that the doctor has prescribed.

Children should not take more than 60 mg of APO-METHYLPHENIDATE per day.

If APO-METHYLPHENIDATE SR (extended-release) tablets have been prescribed, these tablets must be swallowed whole and never be crushed or chewed.

Overdose:
If you think you, or a person you are caring for, have taken too much APO-METHYLPHENIDATE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

The symptoms of overdose are vomiting, agitation, headache, tremors, muscle twitching, irregular heart beat, flushing, fever, sweating, dilated pupils, breathing difficulties, confusion, and fits; muscle spasms, fever, red-brown coloured urine which could be possible signs of abnormal breakdown of muscles (rhabdomyolysis).

Missed Dose:

If a dose of APO-METHYLPHENIDATE is missed, you should take it as soon as possible. The remaining doses for that day should be taken at regularly spaced intervals. Do not take a double dose of APO-METHYLPHENIDATE to make up the missed dose. If you have any questions about this, check with the doctor.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, APO-METHYLPHENIDATE can have some side effects, although not everybody gets them. These are usually mild to moderate and generally do not last long.

Taking APO-METHYLPHENIDATE with food may reduce stomach discomfort.

APO-METHYLPHENIDATE may cause sleeplessness if taken too close to bedtime.

Slower growth (weight gain and/or height) has been reported with long-term use of methylphenidate in children. Your doctor will be carefully watching your height and weight. If you are not growing or gaining weight as your doctor expects, your doctor may stop your APO-METHYLPHENIDATE treatment.

Some side effects are very common:

These side effects may affect more than 1 in 10 patients.

  • sore throat and runny nose

  • decreased appetite

  • nervousness

  • difficulty in falling asleep

  • nausea, dry mouth

Some side effects are common:

These side effects may affect between 1 and 10 in every 100 patients.

  • excessive emotional distress, troubled, sleep disturbance, emotional excitement, restlessness

  • trembling, headache, dizziness, sleepiness

  • changes in blood pressure (usually an increase), abnormal heart rhythm, palpitation

  • cough

  • vomiting, stomach pain, upset stomach, indigestion, toothache

  • skin rash, itchy rash and hives (urticaria), fever, hair loss

  • excessive sweating

  • joint pain

  • decreased weight

  • feeling jittery

  • feeling depressed (depression)

  • feeling aggressive (aggression)

  • excessive teeth grinding (bruxism)

Some side effects are uncommon:

These side effects may affect between 1 and 10 in every 1000 patients.

  • spasm of the jaw muscles that makes it difficult to open the mouth (trismus).

Some side effects are rare:

These side effects may affect between 1 and 10 in every 10,000 patients.

  • slowing of growth (height and weight) during prolonged use in children

  • trouble seeing

Some side effects are very rare:

These side effects may affect less than 1 in every 10,000 patients.

  • low red blood cell count (anemia), low platelet count (thrombocytopenia)

  • unusually active, depressed mood

  • uncontrolled speech and body movements (Tourette’s syndrome)

  • abnormal liver function including liver coma

  • muscle cramps

Some other side effects (Frequency: Not Known):

  • irritated mood changes, abnormal behaviour or thinking, anger, excessive awareness of surroundings, feeling disorientated, changes in sex drive, lack of feeling or emotion, doing things over and over again, being obsessed with one thing, confusion, addiction

  • temporary muscle weakness, loss of skin sensation or other functions of the body due to a temporary lack of blood supply to the brain (reversible ischaemic neurological deficit), migraine

  • double vision, dilated pupils

  • stopped heartbeat, heart attack

  • shortness of breath

  • diarrhea, constipation

  • Other side effects not listed above may occur in some patients. If you notice any other effects, tell your doctor immediately.

    This is not a complete list of possible side effects. Ask your doctor about other side effects. If any side effects develop, talk to your doctor.

  • swelling of face and throat, redness of the skin, large red blotches on the skin appearing within a few hours of taking the medicine

  • muscle pain

  • blood in the urine

  • swelling of the breasts in men

  • tiredness

  • abnormal sounds from heart

  • stuttering (dysphemia)

  • bedwetting in children during the night (enuresis)

 

Other side effects not listed above may occur in some patients. If you notice any other effects, tell your doctor immediately.

This is not a complete list of possible side effects. Ask your doctor about other side effects. If any side effects develop, talk to your doctor.

 

 

 

Serious side effects and what to do about them

Symptom / effect

 

Talk to your healthcare professional

Stop taking

drug and get

immediate

medical help

 

Only if

severe

In all cases

Common

Heart problems: Fast or uneven heartbeat, chest pain, difficulty breathing, fainting

    

✓

Dyskinesia: uncontrollable twitching and jerking

    

✓
 

Raynaud’s Phenomenon: (episodes of reduced blood flow): cold feeling in fingers and toes (and sometimes nose, lips and ears), prickly or stinging feeling, change in skin colour to white then blue

    

✓

Very Rare

Allergic Reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat

    

✓

Cerebrovascular disorders (problems with the blood vessels in the brain): severe headaches, weakness or paralysis of any body part, or problems with coordination, vision, speaking, finding words or with your memory, stroke

     ✓
Neuroleptic Malignant Syndrome: sudden high fever, very high blood pressure and severe convulsions     ✓
Thrombocytopenic purpura: bleeding under the skin, bruising   ✓  

Muscle twitching or tics

 ✓    
Low white blood cell count: sore throat and fever or chills ✓    

Choreo-athetoid movements: uncontrollable writhing movements of the limb, face and/or trunk

   ✓  
Hallucinations : seeing or feeling things that are not really there     ✓
Seizures: fits convulsions, epilepsy     ✓

Exfoliative dermatitis: skin blisters or itching

     ✓
Erythema multiforme: red blotches on the skin   ✓  
Rare Blurred vision   ✓  
Unknown

New Psychotic or Manic Symptoms:- Paranoia, delusions Hallucinations: seeing, feeling or hearing things that are not real Mania: feeling unusually excited, overactive, or uninhibited

   ✓  

Aggressive Behaviour or Hostility

   ✓  
Suicidal Behaviour: Thoughts or actions about suicide or hurting yourself (including completed suicide).     ✓
Priapism: long-lasting (greater than 4 hours in duration) and painful erection of the penis     ✓

Rhabdomyolysis

(breakdown of damaged muscle): muscle weakness, muscle pain, muscle spasms, red-brown coloured urine

   ✓  

 This is not a complete list of side effects. For any unexpected effects while taking APO-METHYLPHENIDATE contact your doctor or pharmacist

​​
HOW TO STORE IT

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

 

APO-METHYLPHENIDATE tablets should not be used 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

Reporting Side Effects

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

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

MORE INFORMATION

If you want more information about APO-METHYLPHENIDATE:

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Date of Revision: October 5, 2023

Report a problem or mistake on this page
Please select all that apply:
Date modified: