Jamp Modafinil: Uses, Side Effects and Dosage

What is JAMP Modafinil used for?

JAMP Modafinil is used to treat adults who are very sleepy due to one of the following medical conditions:

• Narcolepsy: A sleep disorder characterized by sudden attacks of sleep that cannot be controlled.
• Obstructive Sleep Apnea (OSA): A disorder where the muscles in the throat temporarily relax causing breathing problems during sleep. JAMP Modafinil is used along with other medical treatments for this sleep problem. JAMP Modafinil is not a replacement for other treatments that have been prescribed for OSA. It is important that you continue to use these treatments as prescribed by your healthcare professional.
• Shift Work Disorder (SWD): A circadian rhythm sleep disorder characterized by very strong feelings of sleepiness when working long hours or irregular schedules outside the normal sleep period.

JAMP Modafinil is not approved for use in children for any medical condition. How does JAMP Modafinil work?

JAMP Modafinil belongs to a group of medicines called central nervous system (CNS) stimulants. The exact way that JAMP Modafinil works is not known. However, it is thought to stimulate your brain to promote mental and physical processes.

What are the ingredients in JAMP Modafinil?

Medicinal ingredient: Modafinil.

Non-medicinal ingredients: Crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mannitol and povidone.

JAMP Modafinil comes in the following dosage forms:

Tablets; 100 mg of modafinil.

Do not use JAMP Modafinil if:

• you are allergic to modafinil, armodafinil, or to any other ingredient in JAMP Modafinil.
• you have severe anxiety (feel very worried, nervous, or stressed) or are very agitated.
• you are pregnant or plan to become pregnant.

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

• are using a hormonal birth control method (e.g., birth control pills, shots, implants,

  intrauterine devices (IUDs), or patches).

• have high blood pressure.
• have or have had heart or blood vessel problems (e.g., coronary artery disease, heart attacks, unstable angina, and irregular heart beat or rhythm).
• have liver problems.
• have kidney problems.
• have or had a mental health problem.
• have ever had a problem with substance use, including prescribed or illegal drugs, or stimulants (e.g., methylphenidate, amphetamine, or cocaine).

• have one of the following rare genetic conditions:

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

Lactose is a non-medicinal ingredient in JAMP Modafinil.

• have had an allergic reaction to other medicines.
• are breastfeeding or plan to breastfeed. JAMP Modafinil can be passed into breast milk.
• are over the age of 65 years old.

• are drinking or plan to drink alcohol. Avoid consuming alcohol while taking JAMP Modafinil. It is not known how drinking alcohol will affect you when taking JAMP Modafinil.

Other warnings you should know about:

Taking JAMP Modafinil can cause the following:

• Arrhythmia (abnormal heart beats): This can include arrhythmia caused by atrial fibrillation and premature ventricular contractions.
• Hypertension (high blood pressure)

• Myocardial ischemia (lack of blood flow to the heart which can lead to heart attack): It is more likely to develop myocardial ischemia if you:

  • have coronary artery disease,
  • have had a recent heart attack, or
  • have unstable angina (not enough oxygen to the heart muscle).
• Stroke (bleeding or blood clot in the brain)
• Mental and behavioural changes: This can include worsening of emotional or behaviour problems, psychotic episodes, mania, delusions, hallucinations, suicidal ideation and aggression. It is more likely to develop mental and behavioural changes if you have had a previous mental health problem.
• Severe allergic reactions: This can include swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; or a hoarse voice. In severe cases the allergic reaction may affect multiple organs, which can be potentially life-threatening. If any type of allergic reaction is suspected, stop taking JAMP Modafinil right away.
• Severe skin reactions: This can include Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS). These are rare, but serious and potentially fatal skin reactions that may require hospitalization.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Abuse and misuse: Taking JAMP Modafinil can put you at risk for abuse and misuse, especially if you have a history of substance abuse or a history of mental health problems. Your healthcare professional will monitor your risk for these behaviours. However, if you notice any signs of abuse or misuse (e.g., if you have a craving for JAMP Modafinil), tell you healthcare professional right away.

Sleepiness: JAMP Modafinil may help to treat your sleepiness, but it may not stop all of your sleepiness. Discuss your level of sleepiness with your healthcare professional during each visit.

Pregnancy:

• Do not take JAMP Modafinil if you are pregnant as it can harm your unborn baby. If you get pregnant or think you are pregnant while taking JAMP Modafinil or within two months after stopping JAMP Modafinil, tell your healthcare professional right away.
• If you are able to get pregnant you must take a pregnancy test before starting JAMP Modafinil. A negative pregnancy result should be obtained at least a week prior to starting your treatment with JAMP Modafinil. It is recommended that you take pregnancy tests throughout your treatment to allow the early detection of pregnancy.
• JAMP Modafinil can reduce the effects of certain hormonal birth control methods used to prevent pregnancy. These methods can include birth control pills, shots, implants, intrauterine devices (IUDs), or patches. Talk to your healthcare professional to find about the appropriate methods of contraception.

Driving and using machines: JAMP Modafinil can cause over-stimulation and overconfidence. Before you drive or do tasks that require special attention, wait until you are certain that JAMP Modafinil does not affect your ability to engage in these activities.

Monitoring and testing: Your healthcare professional will perform various tests, such as an electrocardiogram (ECG), to monitor your health before, during and after your treatment. This will tell your healthcare professional about your heart, blood profile, blood pressure, and heart rate. They will use this information to determine if JAMP Modafinil is right for you and how it is affecting you.

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

The following may interact with JAMP Modafinil:

• antidepressants used to treat depression (such as clomipramine, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants, and monoamine oxidase (MAO) inhibitors).
• antipyrine, used to treat ear infection pain.
• cyclosporine, used to suppress the immune system.
• other central nervous system (CNS) stimulants used to stimulate the brain (such as dextroamphetamine, methylphenidate, and amphetamines).
• oral birth control (“the pill”).
• anticonvulsants used to prevent or treat seizures (such as phenytoin, S-mephenytoin, and diazepam).
• medicines that belong to a group of medicines called sympathomimetics.
• propranolol, used to treat heart problems.
• warfarin, used to thin the blood and prevent blood clots.
• triazolam, used to treat insomnia (sleep disorder that makes it hard to fall asleep).

How to take JAMP Modafinil:

• Take JAMP Modafinil by mouth exactly as prescribed by your healthcare professional. Do not change your dose or the time of day you take JAMP Modafinil without talking to your healthcare professional.
• JAMP Modafinil does not take the place of getting enough sleep. Follow your healthcare professional’s advice about good sleeping habits.
• You may not feel like JAMP Modafinil is working right away. It may take an hour or so before you feel the effects.

Usual dose:

Your healthcare professional will determine the right dose and time of day for you depending on your condition. Check with them if you are not sure.

The usual adult daily doses are as follows:

• Narcolepsy: One to two tablets (100 mg to 200 mg) in the morning and one to two tablets (100 mg to 200 mg) at noon.
• Obstructive Sleep Apnea (OSA): Two tablets (200 mg) in the morning, in addition to the other prescribed medical treatment(s) for OSA.
• Shift Work Disorder (SWD): Two tablets (200 mg) about 1 hour before the start of the work shift.

It is not recommended to take more than three tablets (300 mg) at one time or four tablets (400 mg) a day.

Overdose:

An overdose with JAMP Modafinil can cause:

• trouble sleeping;
• feeling restless or agitated;
• feeling disoriented;
• feeling confused;
• feeling anxious;
• feeling excited;
• hearing, seeing, feeling or sensing things that are not really there (hallucination);
• nausea;
• diarrhea;
• fast or slow heartbeat;
• increase in blood pressure;
• chest pain.

Missed Dose:

If you forget or miss a dose of JAMP Modafinil, take the dose as soon as you remember unless it is close to the time of your next dose. If it is close to the time of your next dose, skip the missed dose and take the next dose at the usual scheduled time. Taking JAMP Modafinil in the evening or the late afternoon may prevent from falling asleep at usual bedtime, and should, therefore, be avoided. If you are unsure what to do, talk to your healthcare professional.

What are possible side effects from using JAMP Modafinil?

These are not all the possible side effects you may have when taking JAMP Modafinil. If you experience any side effects not listed here, contact your healthcare professional.

Common side effects may include:

• back pain,
• diarrhea,
• difficulty falling asleep,
• drowsiness,
• nervousness,
• sleepiness,
• stuffy nose, or
• upset stomach.

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

Serious side effects and what to do about them

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.

Storage

• Store JAMP Modafinil tablets at room temperature (15°C to 30°C). Protect from moisture.
• Do not use expired medication.
• Keep JAMP Modafinil in a safe place to prevent misuse or abuse.
• Keep out of reach and sight of children.

If you want more information about JAMP Modafinil:

• Talk to your 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html), or by calling 1-866-399-9091.

JAMP Pharma Corporation

1310 rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Last revised: JUN 26, 2024

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/health-canada/services/drugs-health-products/medeffect-canada/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.