Details for: FOQUEST
Company: ELVIUM LIFE SCIENCES
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02470292 | FOQUEST | METHYLPHENIDATE HYDROCHLORIDE | 25 MG | CAPSULE (CONTROLLED RELEASE) | ORAL |
| 02470306 | FOQUEST | METHYLPHENIDATE HYDROCHLORIDE | 35 MG | CAPSULE (CONTROLLED RELEASE) | ORAL |
| 02470314 | FOQUEST | METHYLPHENIDATE HYDROCHLORIDE | 45 MG | CAPSULE (CONTROLLED RELEASE) | ORAL |
| 02470322 | FOQUEST | METHYLPHENIDATE HYDROCHLORIDE | 55 MG | CAPSULE (CONTROLLED RELEASE) | ORAL |
| 02470330 | FOQUEST | METHYLPHENIDATE HYDROCHLORIDE | 70 MG | CAPSULE (CONTROLLED RELEASE) | ORAL |
| 02470349 | FOQUEST | METHYLPHENIDATE HYDROCHLORIDE | 85 MG | CAPSULE (CONTROLLED RELEASE) | ORAL |
| 02470357 | FOQUEST | METHYLPHENIDATE HYDROCHLORIDE | 100 MG | CAPSULE (CONTROLLED RELEASE) | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
FOQUEST is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.
FOQUEST is one part of your or your child’s treatment program. Your or your child’s healthcare professional can help you find the counselling and support that is needed for a complete treatment program.
What it does
FOQUEST contains methylphenidate hydrochloride, which belongs to a group of medicines called central nervous system stimulants. It works by changing the levels of certain chemicals in the brain. This helps to increase attention and decrease impulsivity and hyperactivity in patients with ADHD.
What is Attention Deficit Hyperactivity Disorder (ADHD)?
Patients with ADHD have problems with attention, hyperactivity and impulse control. These symptoms interfere with the patient’s daily life. Some patients have symptoms related to hyperactivity and impulse control while others have symptoms related to inattention. Some patients have both types of symptoms. Many people have symptoms like these from time to time, but patients with ADHD have these symptoms more than others their age.
Symptoms of inattention include:
- Not paying attention
- Making careless mistakes
- Not listening
- Not finishing tasks
- Not following directions
- Having difficulty with organization
- Avoiding or disliking tasks that require a lot of thinking
- Losing things
- Being forgetful
- Being easily distracted
Symptoms of hyperactivity and impulsivity include:
- Fidgeting
- Having difficulty remaining seated
- Feeling restlessness
- Having difficulty with quiet activities
- Often being “on the go”
- Talking excessively
- Having difficulty waiting or taking turns
- Interrupting others
When it should not be used
- are allergic to methylphenidate hydrochloride, any other central nervous system stimulants, or any of the other ingredients in FOQUEST.
- have ever had heart problems such as a heart attack, irregular heartbeat, chest pain, heart failure, heart disease or were born with a heart problem.
- have glaucoma (increased eye pressure).
- have moderate to severe high blood pressure.
- have hardened arteries.
- have an overactive thyroid gland.
- are taking or have taken within the past 14-days medications from a group called monoamine oxidase (MAO) inhibitors.
- have a history of drug abuse.
What the medicinal ingredient is
methylphenidate hydrochloride
What the non-medicinal ingredients are
ammonio methacrylate copolymer dispersion (type B), anionic copolymer (consisting of methyl acrylate, methyl methacrylate and methacrylic acid), glyceryl monostearate, hypromellose, poylethylene glycol, polysorbate, silicon dioxide, sodium hydroxide, sodium lauryl sulfate, sorbic acid, sugar spheres, triethyl citrate
| Strength (mg) | Non-Medicinal Ingredients |
|---|---|
| 25 mg | FD&C Blue No. 1 |
| 35 mg | FD&C Yellow No. 6, Titanium Dioxide |
| 45 mg | FD&C Yellow No. 5, Titanium Dioxide |
| 55 mg | FD&C Blue No. 1, Yellow Iron Oxide, Titanium Dioxide |
| 70 mg | Black Iron Oxide, Titanium Dioxide |
| 85 mg | Titanium Dioxide |
| 100 mg | Yellow Iron Oxide, Red Iron Oxide, Titanium Dioxide |
What dosage form it comes in
Controlled release capsules: 25 mg (blue), 35 mg (orange), 45 mg (yellow), 55 mg (light green), 70 mg (iron gray), 85 mg (white), 100 mg (cream)
Warnings and precautions
Serious Warnings and Precautions
Drug Dependence
Abuse of FOQUEST can lead to dependence. Tell your or your child’s healthcare professional if you or your child have ever abused or been dependent on alcohol or drugs, or are now abusing or dependent on alcohol or drugs.
- have mild high blood pressure, heart problems or heart defects.
- have a family history of sudden cardiac death.
- have thyroid problems.
- have had seizures or abnormal EEGs (measure of brainwave activity).
- do high-intensity exercise or activities.
- have mental health problems or family history of mental health problems, including:
- anxiety
- psychosis
- mania
- bipolar disorder
- depression
- aggression
- suicide
- drink alcohol or have a history of alcohol abuse. You or your child should not drink alcohol while taking FOQUEST.
- have circulation problems in fingers and toes, including numbness, feeling cold or pain (this is also known as Raynaud’s phenomenon).
- are pregnant or plan to become pregnant. FOQUEST should not be used during pregnancy.
- are breastfeeding or plan to breastfeed. FOQUEST can pass through breast milk. You should consult with your or your child’s healthcare professional to determine whether to stop breast-feeding or discontinue FOQUEST.
- take other drugs for ADHD or depression.
- have tics (movements or sounds that you cannot control) or Tourette’s syndrome, or if someone in your family has tics or Tourette’s syndrome.
Other warnings you should know about
Driving and Using Machines
FOQUEST can affect the ability to drive and use potentially dangerous tools or machinery. You or your child should not drive or use tools or machinery until you know how you or your child respond to FOQUEST.
Dependence and Tolerance
Like other stimulants, FOQUEST has the potential to be abused if not taken correctly which can lead to dependence and tolerance. If you or your child have a history of drug or alcohol abuse, discuss this with your or your child’s healthcare professional. Do not change the dose or stop taking FOQUEST without first discussing this with your or your child’s healthcare professional.
Heart Related Problems
The following heart related problems have been reported in people taking medicine to treat ADHD like FOQUEST:
- Sudden death in patients who have heart problems or heart defects
- Stroke and heart attack
- Increased blood pressure
- Increased heart rate
Your or your child’s healthcare professional will check carefully for heart problems before starting FOQUEST and will check blood pressure and heart rate regularly during treatment with FOQUEST.
Seek immediate medical help if you or your child have any signs of heart problems such as chest pain, difficulty breathing or fainting while taking FOQUEST.
Mental Health Problems
The following mental health problems have been reported in people taking medicine to treat ADHD like FOQUEST:
- New or worse thoughts or feelings of suicide (thinking about or feeling like killing yourself) and suicide attempt
- New or worse bipolar disorder (extreme mood swings, with periods of 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)
These new or worse mental health problems may be more likely to happen if you or your child have mental health conditions. These symptoms can happen at any time during treatment but are more likely to occur when you or your child first start taking FOQUEST, when the dose changes, or after stopping FOQUEST treatment.
A small number of patients taking ADHD drugs may have feelings of:
- agitation
- hostility
- anxiety, or
- have thoughts of suicide, self-harm or harm to others.
Seek immediate medical help if you or your child have any mental health symptoms while taking FOQUEST.
Tell your healthcare professional about all the medicines you or your child take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
- Alcohol should be avoided, including any medications containing alcohol, such as some cough syrups, while taking FOQUEST
- Clonidine used to treat ADHD
- Certain medicines used to treat or prevent blood clot, such as warfarin
- Certain medicines used to treat seizures, such as phenobarbital, phenytoin, or primidone
- Certain medicines for depression and mood disorders, such as Tricyclic Antidepressants (e.g. amitriptyline) and Selective Serotonin Reuptake Inhibitors (SSRIs). Do not take FOQUEST with monoamine oxidase (MAO) inhibitors or if you or your child have taken MAO inhibitors in the last 14-days before treatment with FOQUEST.
- Certain medicines used to treat high blood pressure
- Your or your child’s healthcare professional will decide the dose that is right. Always follow the directions of the healthcare professional and never change the dose or stop taking FOQUEST without first discussing it with your or your child’s healthcare professional.
- FOQUEST should be taken once-a-day, with or without food, as soon as possible in the morning as the effects of FOQUEST can last late into the evening and may affect sleep.
- FOQUEST capsules should be swallowed whole with a full glass of water and must never be crushed or chewed.
- For patients unable to swallow the capsule, the capsule may be opened and the entire contents sprinkled onto applesauce, ice cream or yogurt. Do not sprinkle in liquids.
To sprinkle FOQUEST onto food
- Measure a tablespoon of applesauce, ice cream or yogurt.
- Open the capsule.
- Sprinkle the entire contents (beads) onto the tablespoon.
- Take the entire mixture immediately or within 10 minutes.
- Do not chew the capsule contents (beads).
- Rinse your or your child’s mouth with water and swallow the water.
- Do not keep any of the food/medicine mixture for another dose.
- Throw out any food/medicine mixture if:
- it has been more than 10 minutes since you sprinkled the capsule onto the food.
- you do not remember when you sprinkled the capsule onto the food.
- you do not remember which food you sprinkled the capsule onto.
Usual Dose
- Take the dose prescribed by your or your child’s healthcare professional.
- The starting dose will depend on whether you or your child have already been taking a medication that contains methylphenidate (the ingredient in FOQUEST).
- The healthcare professional may adjust the amount of medicine until it is right for you or your child.
- From time to time, the healthcare professional may interrupt treatment with FOQUEST to check for symptoms while you or your child are not taking the medicine.
The maximum daily dose for children and adolescents (6 to <18 years old) is 70 mg.
The maximum daily dose for adults (≥18 years old) is 100 mg.
Overdose
If you think you or your child have taken too much FOQUEST, contact your or your child’s healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you or your child forget to take the 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.
These are not all the possible side effects that you or your child may feel when taking FOQUEST. If you or your child experience any side effects not listed here, contact your or your child’s healthcare professional.
Side effects may include:
- Loss of appetite
- Headache
- Insomnia, sleep disorder
- Abdominal pain and discomfort
- Dry mouth
- Diarrhea, nausea, vomiting
- Fatigue, drowsiness
- Feeling jittery
- Weight loss, weight gain
- Sinus infection, common cold
- Heart rate increase
- Dizziness
- Irritability
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Very Common | |||
Mental Health Problems:
|
✔ | ||
| Common | |||
| Heart Problems: fast heartbeat, palpitations, chest pain, difficulty breathing, fainting | ✔ | ||
| Eye Problems: blurred vision, abnormal blinking or eyelid spasms | ✔ | ||
| Unknown | |||
| Suicidal Behaviour: thoughts or feelings about harming yourse | ✔ | ||
| Raynaud’s Phenomenon: discoloration of the fingers and toes, pain, sensations of cold and/or numbness | ✔ | ||
| Seizures or Convulsions: loss of consciousness with uncontrollable shaking (fit) | ✔ | ||
| Serious Allergic Reaction: itching, skin rash, swelling of the mouth, face, lips, or tongue, trouble swallowing, trouble breathing | ✔ | ||
| Priapism: long-lasting (greater than 4 hours in duration) and painful erection of the penis | ✔ | ||
| Bladder Infection: increased need to urinate, pain when urinating, blood in the urine | ✔ | ||
| Tourette’s Syndrome: motor tics (hard-to-control, repeated twitching of any part of your body) and verbal tics (hard-to-control repeating of sounds or words) | ✔ | ||
| Edema: swollen hands, ankles or feet | ✔ | ||
If you or your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with daily activities, talk to your or your child’s healthcare professional.
Keep unused or expired FOQUEST in a secure place to prevent theft, misuse or accidental exposure. Keep FOQUEST out of sight and reach of children and pets.
Store at room temperature (15°C to 30°C). Protect from moisture.
Disposal:
FOQUEST should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.
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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
- Talk to your or your child’s healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.elvium.ca, or by calling 1-800-387-4501
This leaflet was prepared by Elvium Life Sciences.
FOQUEST® and MLR® are registered trademarks of Elvium Life Sciences
Last Revised: August 20, 2020
Interactions with this medication
- Alcohol should be avoided, including any medications containing alcohol, such as some cough syrups, while taking FOQUEST
- Clonidine used to treat ADHD
- Certain medicines used to treat or prevent blood clot, such as warfarin
- Certain medicines used to treat seizures, such as phenobarbital, phenytoin, or primidone
- Certain medicines for depression and mood disorders, such as Tricyclic Antidepressants (e.g. amitriptyline) and Selective Serotonin Reuptake Inhibitors (SSRIs). Do not take FOQUEST with monoamine oxidase (MAO) inhibitors or if you or your child have taken MAO inhibitors in the last 14-days before treatment with FOQUEST.
- Certain medicines used to treat high blood pressure
Proper use of this medication
- Your or your child’s healthcare professional will decide the dose that is right. Always follow the directions of the healthcare professional and never change the dose or stop taking FOQUEST without first discussing it with your or your child’s healthcare professional.
- FOQUEST should be taken once-a-day, with or without food, as soon as possible in the morning as the effects of FOQUEST can last late into the evening and may affect sleep.
- FOQUEST capsules should be swallowed whole with a full glass of water and must never be crushed or chewed.
- For patients unable to swallow the capsule, the capsule may be opened and the entire contents sprinkled onto applesauce, ice cream or yogurt. Do not sprinkle in liquids.
To sprinkle FOQUEST onto food
- Measure a tablespoon of applesauce, ice cream or yogurt.
- Open the capsule.
- Sprinkle the entire contents (beads) onto the tablespoon.
- Take the entire mixture immediately or within 10 minutes.
- Do not chew the capsule contents (beads).
- Rinse your or your child’s mouth with water and swallow the water.
- Do not keep any of the food/medicine mixture for another dose.
- Throw out any food/medicine mixture if:
- it has been more than 10 minutes since you sprinkled the capsule onto the food.
- you do not remember when you sprinkled the capsule onto the food.
- you do not remember which food you sprinkled the capsule onto.
Usual Dose
- Take the dose prescribed by your or your child’s healthcare professional.
- The starting dose will depend on whether you or your child have already been taking a medication that contains methylphenidate (the ingredient in FOQUEST).
- The healthcare professional may adjust the amount of medicine until it is right for you or your child.
- From time to time, the healthcare professional may interrupt treatment with FOQUEST to check for symptoms while you or your child are not taking the medicine.
The maximum daily dose for children and adolescents (6 to <18 years old) is 70 mg.
The maximum daily dose for adults (≥18 years old) is 100 mg.
Overdose
If you think you or your child have taken too much FOQUEST, contact your or your child’s healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you or your child forget to take the 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.
Side effects and what to do about them
These are not all the possible side effects that you or your child may feel when taking FOQUEST. If you or your child experience any side effects not listed here, contact your or your child’s healthcare professional.
Side effects may include:
- Loss of appetite
- Headache
- Insomnia, sleep disorder
- Abdominal pain and discomfort
- Dry mouth
- Diarrhea, nausea, vomiting
- Fatigue, drowsiness
- Feeling jittery
- Weight loss, weight gain
- Sinus infection, common cold
- Heart rate increase
- Dizziness
- Irritability
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Very Common | |||
Mental Health Problems:
|
✔ | ||
| Common | |||
| Heart Problems: fast heartbeat, palpitations, chest pain, difficulty breathing, fainting | ✔ | ||
| Eye Problems: blurred vision, abnormal blinking or eyelid spasms | ✔ | ||
| Unknown | |||
| Suicidal Behaviour: thoughts or feelings about harming yourse | ✔ | ||
| Raynaud’s Phenomenon: discoloration of the fingers and toes, pain, sensations of cold and/or numbness | ✔ | ||
| Seizures or Convulsions: loss of consciousness with uncontrollable shaking (fit) | ✔ | ||
| Serious Allergic Reaction: itching, skin rash, swelling of the mouth, face, lips, or tongue, trouble swallowing, trouble breathing | ✔ | ||
| Priapism: long-lasting (greater than 4 hours in duration) and painful erection of the penis | ✔ | ||
| Bladder Infection: increased need to urinate, pain when urinating, blood in the urine | ✔ | ||
| Tourette’s Syndrome: motor tics (hard-to-control, repeated twitching of any part of your body) and verbal tics (hard-to-control repeating of sounds or words) | ✔ | ||
| Edema: swollen hands, ankles or feet | ✔ | ||
If you or your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with daily activities, talk to your or your child’s healthcare professional.
How to store
Keep unused or expired FOQUEST in a secure place to prevent theft, misuse or accidental exposure. Keep FOQUEST out of sight and reach of children and pets.
Store at room temperature (15°C to 30°C). Protect from moisture.
Disposal:
FOQUEST should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.
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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
- Talk to your or your child’s healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.elvium.ca, or by calling 1-800-387-4501
This leaflet was prepared by Elvium Life Sciences.
FOQUEST® and MLR® are registered trademarks of Elvium Life Sciences
Last Revised: August 20, 2020