Patient Medication Information: uses, side effects, how to take - Teva-Lisdexamfetamine (Teva Canada, 10 mg, ..., 60 mg)

Serious warnings and precautions box

Drug dependence: Like other stimulants, Teva-Lisdexamfetamine has the potential to be abused. This can lead to you becoming dependent on Teva-Lisdexamfetamine or feeling like you need to take more of it over time.

Misusing Teva-Lisdexamfetamine may cause serious heart problems and even sudden death.

What Teva-Lisdexamfetamine is used for:

Teva-Lisdexamfetamine is used to treat:

Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age or older, adolescents and adults. Treatment with Teva-Lisdexamfetamine for ADHD should be combined with other measures, such as psychological counselling, educational and social measures, as part of a total treatment program. Teva-Lisdexamfetamine is NOT recommended for use in children with ADHD under 6 years of age.
moderate to severe Binge Eating Disorder (BED) in adults. Teva-Lisdexamfetamine is NOT recommended for use in children with BED under 18 years of age.

Use of other stimulant medicines for weight loss has been associated with serious heart-related problems. It is not known if Teva-Lisdexamfetamine is safe and effective for weight loss.

How Teva-Lisdexamfetamine works:

Teva-Lisdexamfetamine belongs to a group of medicines called central nervous system stimulants. Teva-Lisdexamfetamine is a prodrug, which means that the medicinal ingredient lisdexamfetamine dimesylate is inactive until the body breaks it down into its active form called dextroamphetamine. It works by raising the levels of chemicals in the brain called dopamine and norepinephrine.

This helps to increase attention and decrease impulsiveness and hyperactivity in patients with ADHD;
This may help to reduce the number of binge eating days in adults with BED.

The ingredients in Teva-Lisdexamfetamine are:

Medicinal ingredient: Lisdexamfetamine dimesylate

Nonmedicinal ingredients:

Colloidal Silicon Dioxide, Croscarmellose Sodium, Guar Gum, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Sucralose and Strawberry Flavour.

Strawberry Flavour includes artificial flavours, corn syrup, medium chain triglycerides and modified corn starch

Teva-Lisdexamfetamine comes in the following dosage forms:

Chewable Tablets: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg

Do not use Teva-Lisdexamfetamine if:

you are allergic to amphetamines, the medicinal ingredient lisdexamfetamine dismesylate or its active form (i.e., dextroamphetamine) or any of the other ingredients in Teva-Lisdexamfetamine.
you are sensitive to, allergic to or had a reaction to other stimulant medicines.
you have advanced arteriosclerosis (hardened arteries).
you have symptoms of heart disease.
you have moderate to severe high blood pressure.
you are agitated.
you have glaucoma (an eye disease with increased pressure in the eye).
you have hyperthyroidism (an overactive thyroid gland).
you have a condition called pheochromocytoma (a rare tumour that usually grows in the adrenal glands, above your kidneys).
you are taking or have recently taken (in the past 14 days) any medications from the group called monoamine oxidase inhibitors (MAOIs).
you have a history of drug abuse.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Teva-Lisdexamfetamine. 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 cardiac death or death related to heart problems.
have mild high blood pressure.
do strenuous exercise.
have a history of seizures (convulsions, epilepsy) or have had abnormal brainwave tests (electroencephalogram; EEGs).
have or have a family history of tics (movements or sounds that you cannot control) or Tourette’s syndrome.
take other medications for ADHD.
take blood pressure medications or other medicines that can affect blood pressure.
have or have a family history of mental health problems, including:
- psychosis,
- mania,
- bipolar disorder
- depression, or
- suicide.
have severe kidney problems, including if you are undergoing dialysis.
have a history of drug abuse or alcoholism.
are pregnant, think you are pregnant or are planning to become pregnant.
are breastfeeding or plan to breastfeed.

Other warnings you should know about:

Dependence and tolerance:

Amphetamines, such as Teva-Lisdexamfetamine, have the potential to cause drug abuse and misuse.
Abuse of amphetamines can lead to dependence, tolerance, social disorders and possibly serious heart problems and death.
Long term misuse of amphetamines may cause:
- skin disease;
- sleeping problems;
- personality changes;
- anxious and distressful feelings;
- rash, uncontrolled behaviour;
- psychosis;
- schizophrenia.

Healthcare professional supervision is needed when you stop taking Teva-Lisdexamfetamine. Suddenly ending treatment when taking higher doses of Teva-Lisdexamfetamine for a long period of time can cause

extreme fatigue;
depression;
changes in sleep patterns.
Teva-Lisdexamfetamine should only be given under close medical supervision to patients whose condition has been properly diagnosed.

Driving and using machines: Teva-Lisdexamfetamine can affect your ability to drive and use tools or machinery. You should not drive or use tools or machinery until you know how you respond to Teva-Lisdexamfetamine.

Pregnancy and breastfeeding:

Taking Teva-Lisdexamfetamine during pregnancy can harm your unborn baby. It should not be used during pregnancy unless your healthcare professional has determined the potential benefits outweigh the potential risks to your baby. Your healthcare professional will discuss these risks with you. If you discover that you are pregnant while taking Teva-Lisdexamfetamine, tell your healthcare professional right away.
Teva-Lisdexamfetamine can pass through your breast milk and may harm your baby. You should consult with your healthcare professional to determine if you should stop breastfeeding or discontinue Teva-Lisdexamfetamine.

The following have been reported with use medicines used to treat ADHD such as Teva-Lisdexamfetamine:

Growth in children: Slower growth (in weight and/or height) has been reported with the use of lisdexamfetamine dimesylate in children. This risk increases as the dose of Teva-Lisdexamfetamine increases. The healthcare professional will be monitoring the child’s height and weight while they are taking Teva-Lisdexamfetamine. If the child is not growing or gaining weight as expected, the healthcare professional may stop treatment.

Heart-related problems: The following heart related problems have been reported in people taking medications to treat ADHD, like Teva-Lisdexamfetamine:

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 medicines for ADHD treatment in children and adolescents with structural heart abnormalities. Teva-Lisdexamfetamine generally should not be used in children, adolescents or adults with known structural heart abnormalities. There may be additional heart-related risks if you are overweight or obese.

Tell your healthcare professional if you 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 Teva-Lisdexamfetamine.
your blood pressure and heart rate before and regularly during treatment with Teva-Lisdexamfetamine.

Seek immediate medical help if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Teva-Lisdexamfetamine.

Mental health problems: The following mental health problems have been reported in people taking stimulant medicines like Teva-Lisdexamfetamine:

New or worse thoughts or feelings related to suicide (thinking about or feeling like killing yourself) and suicidal actions (suicide attempt, suicidal ideation and completed suicide).
New or worse symptoms of bipolar disorder (extreme mood swings, with periods of impulsiveness or unusual excitement, switching between periods of sadness).
New or worse aggressive behavior or hostility.
New psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new mania (unusually excited, over-active or un-inhibited).

These new or worse mental symptoms may be more likely to occur if you 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 have.

A small number of patients taking ADHD medicines 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 behaviours may occur at any time during treatment, particularly at the start or during dose changes, and also after stopping Teva-Lisdexamfetamine. 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 Teva-Lisdexamfetamine 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.

Raynaud’s phenomenon (episodes of reduced blood flow): Stimulant medicines, such as Teva-Lisdexamfetamine, are associated with Raynaud’s phenomenon. During treatment with Teva-Lisdexamfetamine, your healthcare professional may check for problems with the circulation in your fingers and toes, including numbness, feeling cold or pain.

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 Teva-Lisdexamfetamine include:

any monoamine oxidase inhibitors (MAOIs) such as phenelzine, tranylcypromine, or moclobemide as it may have serious side effects. Do not take Teva-Lisdexamfetamine if you are taking or have recently taken (in the last 14 days) any MAOIs.

The following may interact with Teva-Lisdexamfetamine:

other medications used to treat ADHD, such as guanfacine.
medicines used to treat depression or anxiety such as:
- certain tricyclic antidepressants,
- selective serotonin reuptake inhibitors (SSRIs), and
- serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine.
certain medicines used to treat migraines such as sumatriptan, rizatriptan or zolmitriptan.
medicines used to manage psychotic symptoms such as pimozide, haloperidol and chlorpromazine.
medicines that make the urine more acidic such as ammonium chloride and sodium acid phosphate, as well as the dietary supplement ascorbic acid (vitamin C).
medicines that make urine more alkaline such as sodium bicarbonate, acetazolamide and thiazides.
blood pressure medications or other medicines that can affect blood pressure such as beta blockers and norepinephrine.
opioid medicines, used to relieve pain.
lithium, used to treat manic episodes in bipolar disorder.
modafinil, used to treat sleepiness due to narcolepsy.
certain radioactive agents (used for diagnostic tests). This can cause false-positive test results and your healthcare professional may ask you to stop taking Teva-Lisdexamfetamine for a short period before the diagnostic test.
St John’s Wort, a herbal remedy.

How to take Teva-Lisdexamfetamine:

Take Teva-Lisdexamfetamine once each day in the morning, with or without food.
Avoid taking Teva-Lisdexamfetamine in the afternoon as it may cause insomnia.
If you were prescribed Teva-Lisdexamfetamine chewable tablets, you must chew the tablet thoroughly before swallowing. The entire tablet should be taken. Do not divide the dose.
As with all medicines, never share Teva-Lisdexamfetamine with anyone else.

Usual dose:

To treat Attention Deficit Hyperactivity Disorder (ADHD) (children 6 years of age or older, adolescents and adults):
Your healthcare professional will decide the dose that is right for you. Always follow the directions of your healthcare professional and never change the dose or stop taking Teva-Lisdexamfetamine without discussing it with your healthcare professional first.
The usual dose is 20 mg to 60 mg once a day. Take Teva-Lisdexamfetamine in the morning exactly as prescribed. Your healthcare professional may adjust the dose until it is right for you. The maximum daily dose is 60 mg.
From time to time, your healthcare professional may interrupt your treatment to check your symptoms while you are not taking the medicine.
To treat moderate to severe Binge Eating Disorder (BED) (adults):
The recommended starting dose is 30 mg once a day in the morning. Your healthcare professional will then gradually increase your daily dose by 20 mg each week. They will do this until you’re taking 50 mg to 70 mg once a day in the morning. The maximum daily dose is 70 mg.

Overdose:

If you think you, or a person you are caring for, have taken too much Teva-Lisdexamfetamine, 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 forget to take your dose in the morning, wait until the next day and take the usual dose at the usual time in the morning. Do not take an afternoon dose. Do not double the dose to make up for the missed dose.

Possible side effects from using Teva-Lisdexamfetamine:

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

Side effects with Teva-Lisdexamfetamine may include:

headache, dizziness, feeling like your environment is moving or spinning (vertigo)
dry mouth, decreased appetite, anorexia (eating disorder)
trouble sleeping or falling asleep, feeling sleepy
upper abdominal pain, constipation or diarrhea, vomiting or nausea, indigestion
numbness, or pricking or tingling sensations in the hands, arms, legs or feet
fever, upper respiratory tract infection, stuffy nose or sore throat
feeling irritable, anxious or jittery, lack or abundance of energy, rapid and sometimes exaggerated changes in mood
decreased sex drive, inability to get or keep an erection
bladder infection
skin rash, hives, itchy skin
ringing in the ears
unusual dilation or widening of the pupils
weight changes
changes in taste
excessive sweating
nightmares
clenching of teeth
hair loss
memory problems
muscle aches and pain

Serious side effects and what to do about them

Serious side effects and what to do about them
Frequency/Side Effect/effect	Talk to your healthcare professional			Stop taking this drug and get immediate medical help
Frequency/Side Effect/effect	Talk to your healthcare professional			Stop taking this drug and get immediate medical help
	Only if severe		In all cases
	Only if severe		In all cases
Common
Anxiety		✓
New or worsening tics: movements or sounds that you cannot control			✓
Slowing of growth (height and weight) in children			✓
Palpitation (fast-beating, fluttering or pounding heart)			✓
Uncommon
Aggressive behaviour or hostility			✓
Allergic reaction: difficulty swallowing or breathing, and throwing up, swelling of the face, lips, tongue or throat, hives or rash					✓
Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family gatherings and activities with friends, reduced libido (sex drive) and thoughts of death or suicide. If you have a history of depression, your depression may become worse			✓
New or worsening mental health problems: paranoia, delusions, hallucinations (seeing, feeling or hearing things that are not there), mania (feeling unusually excited, over-active, or uninhibited), compulsions			✓
Vision problems: changes in vision or blurry vision			✓
Unknown
Epistaxis and contusion: unexplained nosebleeds or bruising		✓
Heart attack: severe, crushing chest pain that can radiate into the arm and/or jaw, upper back or neck, palpitation, shortness of breath, nausea, vomiting,					✓
sweating, indigestion, heartburn, dizziness, extreme fatigue, upper body discomfort
Seizures (fits): uncontrollable shaking with or without loss of consciousness					✓
Intestinal ischemia (blood flow to your intestines decreases due to a narrowed or blocked blood vessel): sudden or worsening abdominal pain (usually severe), urgent need to have a bowel movement, frequent, forceful bowel movements, nausea, vomiting, diarrhea, blood in your stool, confusion in older adults					✓
Liver disorder: yellowing of the skin or whites of the eyes (jaundice), dark urine and pale stools, abdominal pain, nausea, vomiting, loss of appetite					✓
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			✓
Stevens-Johnson syndrome (SJS) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands					✓
Suicidal behaviour: thoughts or actions about hurting or killing yourself					✓
Serotonin toxicity (also known as serotonin syndrome): feeling of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (above 38°C), rigid muscles					✓
Cerebrovascular disorders (problems with the blood vessels in the brain, stroke): severe headaches, weakness or paralysis of any body part, or problems with coordination, vision, speaking, finding words or with your memory					✓
Rhabdomyolysis (breakdown of damaged muscle): muscle weakness, muscle pain, muscle spasms, red-brown coloured urine			✓
Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or fast or uneven heartbeat.		✓

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

Store Teva-Lisdexamfetamine Chewable Tablets at 15 to 30°C. Keep this medication out of the sight and reach of children.

If you want more information about Teva-Lisdexamfetamine:

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 website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.tevacanada.com), or by calling 1-800-268-4127 ext. 3; or email email druginfo@tevacanada.com.

Date of Authorization: 2026-03-27

Teva-Lisdexamfetamine (Teva Canada, 10 mg, ..., 60 mg): Uses, Side Effects and Dosage