IMPORTANT SAFETY INFORMATION

PLEASE READ Medication Information: MOD Alert (Modafinil, and Caffeine)

Modafinil + Caffeine by MOD is used for:

• Shift Work Sleep Disorder- Related Excessive Daytime Sleepiness

Do NOT take this medication if you:

• Have an allergy to modafinil, including symptoms like rash, hives, itching, shortness of breath, wheezing, cough, swelling of the face, lips, tongue, or throat, or any other signs of an allergic reaction.
• Have a history of mitral valve prolapse syndrome with CNS stimulants.
• Are under 21 years old.
• Are biologically female.

IMPORTANT

• Do NOT drink alcohol while taking this medication, as it can make the medication less effective and increase potential side effects.
• Do NOT consume grapefruit or grapefruit juice while taking this medication. Grapefruit can interfere with how your body processes the medication, causing higher levels to stay in your system longer, which may lead to unwanted side effects.
• Do NOT share this medication with others. It is prescribed specifically for you and may be harmful or fatal if used by someone else. Store it in a safe place to prevent misuse or abuse.
• Avoid activities that require full alertness, such as driving or operating heavy machinery, until you understand how this medication affects you.
• Experiencing a heightened mood or energy boost could lead to misuse or dependence, especially in individuals with a history of substance abuse.
• Inform all your healthcare providers—including doctors, nurses, pharmacists, and dentists—that you are taking this medication.
• This medication does not replace getting enough sleep.
• STOP treatment and notify us immediately if you begin taking any new medications.
• STOP treatment and notify us immediately if you develop any new medical conditions.

CONSIDERATIONS

• This treatment is not recommended for patients with certain cardiovascular or psychiatric conditions/history.
• Modafinil does not treat the underlying causes of sleep disorders (e.g., obstructive sleep apnea). It is important to continue your current treatments as directed. Do not stop or change them unless your healthcare provider advises you to do so.
• Modafinil stays active in the body for around 15 hours, so taking it later in the day could interfere with your ability to sleep at night.
• Individual responses to caffeine can vary. Even if you normally tolerate caffeine well, you may still experience temporary effects such as jitteriness, restlessness, shaking, digestive changes, anxiety, or nervousness. If these symptoms become concerning, discontinue the medication and contact us.
• Caffeine may impact sleep. If you notice it keeps you awake, avoid taking caffeine-containing treatments within 6 hours of bedtime.
• This medication may be taken with or without food.
• Staying well-hydrated can help minimize potential side effects of the medication.

Common Side Effects of Modafinil

• Headache
• Nausea
• Diarrhea
• Dizziness
• Runny nose
• Back pain
• Indigestion
• Nervousness
• Palpitations
• Increased heart rate
• Increased blood pressure

When to Seek Emergency Medical Help

Stop taking the medication and seek IMMEDIATE medical attention if you experience:

• Chest pain
• A heartbeat that does not feel normal
• Trouble breathing that is new or worse
• Swelling in the face, lips, arms, or legs
• Signs of a serious skin reaction (such as rash, blistering, or peeling skin)
• Fever
• Persistent sleepiness
• New onset of mania
• Agitation or confusion
• Delusions, hallucinations, or psychosis
• Suicidal thoughts

Allergic Reaction

• Seek emergency medical help right away if you have signs of a severe allergic reaction, including hives, itching, red or swollen skin, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
• Also seek emergency care if you develop symptoms of a serious skin reaction, such as Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN), including rash, blistering, or peeling skin, with or without fever.

Overdose

• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

PLEASE READ Medication Information: MOD FOCUS (Modafinil, Atomoxetine, and Caffeine)

Modafinil + Atomoxetine + Caffeine by MOD is used for:

• Shift Work Sleep Disorder- Related Excessive Daytime Sleepiness

Do NOT take this medication if you:

• Have an allergy to modafinil or atomoxetine, including symptoms like rash, hives, itching, shortness of breath, wheezing, cough, swelling of the face, lips, tongue, or throat, or any other signs of an allergic reaction.
• Are allergic and/or hypersensitive to armodafinil, caffeine, or any component of these formulations.
• Are taking a monoamine oxidase inhibitor (MAOI) or have taken one within the past 14 days (e.g., isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, rasagiline, safinamide, selegiline, tranylcypromine)
• Have a history of:
  • Mitral valve prolapse syndrome with CNS stimulants
  • Narrow-angle glaucoma
  • Pheochromocytoma
  • Severe cardiac or vascular disorders
• Are under 21 years old.
• Are biologically female.

IMPORTANT

• Do NOT take with other stimulants as it can lead to an increased risk of adverse effects, especially in the cardiovascular system.
• Do NOT drink alcohol while taking this medication, as it can make the medication less effective and increase potential side effects.
• Do NOT consume grapefruit or grapefruit juice while taking this medication. Grapefruit can interfere with how your body processes the medication, causing higher levels to stay in your system longer, which may lead to unwanted side effects.
• Do NOT share this medication with others. It is prescribed specifically for you and may be harmful or fatal if used by someone else. Store it in a safe place to prevent misuse or abuse.
• Inform all your healthcare providers—including doctors, nurses, pharmacists, and dentists that you are taking this medication.
• Avoid activities that require full alertness, such as driving or operating heavy machinery, until you understand how this medication affects you.
• Experiencing a heightened mood or energy boost could lead to misuse or dependence, especially in individuals with a history of substance abuse.
• Modafinil and Atomoxetine do NOT replace getting enough sleep.
• STOP treatment and notify us immediately if you begin taking any new medications.
• STOP treatment and notify us immediately if you develop any new medical conditions.

CONSIDERATIONS

• This treatment is not recommended for patients with certain cardiovascular or psychiatric conditions/history.
• Modafinil does not treat the underlying causes of sleep disorders (e.g., obstructive sleep apnea). It is important to continue your current treatments as directed. Do not stop or change them unless your healthcare provider.
• Modafinil stays active in the body for about 15 hours, while Atomoxetine can stay active in the body for up to 24 hours, so taking the medication later in the day could potentially interfere with your ability to sleep.
• Individual responses to caffeine can vary. Even if you normally tolerate caffeine well, you may still experience temporary effects such as jitteriness, restlessness, shaking, digestive changes, anxiety, or nervousness. If these symptoms become concerning, discontinue the medication and contact us.
• Caffeine may impact sleep. If you notice it keeps you awake, avoid taking caffeine-containing treatments within 6 hours of bedtime.
• This medication may be taken with or without food.
• Staying well-hydrated can help minimize potential side effects of the medication.

Common Side Effects

Modafinil

• Headache
• Nausea
• Diarrhea
• Dizziness
• Runny nose
• Back pain
• Indigestion
• Nervousness
• Palpitations
• Increased heart rate
• Increased blood pressure

Atomoxetine

• Headache
• Dizziness
• Fatigue
• Abdominal pain
• Decreased appetite
• Nausea
• Vomiting
• Dry mouth
• Erectile dysfunction
• Excessive sweating
• Increased heart rate
• Increased blood pressure

When to Seek Emergency Medical Help

Stop taking the medication and seek IMMEDIATE medical attention if you experience:

Modafinil

• Chest pain
• A heartbeat that does not feel normal
• Trouble breathing that is new or worse
• Swelling in the face, lips, arms, or legs
• Signs of a serious skin reaction (such as rash, blistering, or peeling skin)
• Fever
• Persistent sleepiness
• New onset of mania
• Agitation or confusion
• Delusions, hallucinations, or psychosis
• Suicidal thoughts

Atomoxetine

• Chest pain
• A heartbeat that does not feel normal
• Persistent dizziness or passing out
• Trouble breathing that is new or worse
• Swelling in the face, lips, arms, or legs
• Symptoms of serious skin reactions, such as rash, blistering, peeling skin
• Fever
• Persistent sleepiness
• New onset mania
• Agitation or confusion
• Hostility or irritability
• Delusions, hallucinations, or psychosis
• Suicidal thoughts
• Dark urine or yellowing of the skin or eyes
• Inability to pass urine

Allergic Reaction

• Seek emergency medical help right away if you have signs of a severe allergic reaction, including hives, itching, red or swollen skin, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
• Also seek emergency care if you develop symptoms of a serious skin reaction, such as Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN), including rash, blistering, or peeling skin, with or without fever.

Overdose

• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.