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APO-MODAFINIL is a brand name for Modafinil, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-MODAFINIL (modafinil) is indicated for: • The symptomatic treatment of excessive sleepiness in adult patients with narcolepsy. In narcolepsy, APO-MODAFINIL has no significant effect on cataplexy. • The symptomatic treatment of excessive sleepiness in adult patients with obstructive sleep apnea (OSA). In OSA,…
Verbatim from this product's HC label. Tap a section to expand.
06/2023 7 WARNINGS AND PRECAUTIONS, Alcohol Consumption, Risk of stroke 06/2023 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS ...............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 4 1 INDICATIONS ...................................................................................................................
1 Pediatrics ................................................................................................................... 2 Geriatrics ...................................................................................................................
5 2 CONTRAINDICATIONS ....................................................................................................... 5 4 DOSAGE AND ADMINISTRATION .......................................................................................
1 Dosing Considerations ............................................................................................... 2 Recommended Dose and Dosage Adjustment .......................................................... 5 Missed Dose ..............................................................................................................
7 5 OVERDOSAGE ................................................................................................................... 7
1 Adverse Reaction Overview The most commonly observed adverse events (≥5%) associated with the use of modafinil tablets and observed more frequently than placebo treated patients in the placebo controlled clinical studies in primary disorders of sleep and wakefulness were headache, nausea, rhinitis, nervousness, diarrhea, back pain, anxiety, dizziness, dyspepsia, and insomnia.
The adverse event profile was similar across these studies. In the placebo controlled clinical trials, 74 of the 934 patients (8%) who received modafinil discontinued due to an adverse experience compared to 3% of patients that received placebo.
The most frequent reasons for discontinuation that occurred at a higher rate for modafinil than placebo patients were headache (2%), anxiety (1%), nervousness (1%), agitation, chest pain, confusion, depression, dizziness, insomnia, and nausea (each <1%).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The following table presents the adverse experiences that occurred at a rate of 1% or more and were more frequent in adult patients treated with modafinil than in placebo-treated patients in the principal, placebo-controlled clinical trials.
Table 2:
Incidence of Treatment-Emergent Adverse Experiences in Parallel-Group, Placebo- controlled Clinical Trials1 with Modafinil in Adults with Narcolepsy and Obstructive Sleep Apnea and Circadian Rhythm Sleep Disorder, Shift Work Type (Shift Work Disorder) (200 mg, 300 mg and 400 mg)* Product Monograph APO-MODAFINIL (Modafinil Tablets) Page 17 of 48 Modafinil n=934 (%) Placebo n=567 (%) Body as Whole Headache Back Pain Flu Syndrome Chest Pain Chills Neck Rigidity 34% 6% 4% 3% 1% 1% 23% 5% 3% 1% 0% 0% Cardiovascular Hypertension Tachycardia Palpitation Vasodilatation 3% 2% 2% 2% 1% 1% 1% 0% Digestive Nausea Diarrhea Dyspepsia Dry Mouth Anorexia Constipation Abnormal Liver Function2 Flatulence Mouth Ulceration Thirst 11% 6% 5% 4% 4% 2% 2% 1% 1% 1% 3% 5% 4% 2% 1% 1% 1% 0% 0% 0% Hemic/Lymphatic Eosinophilia 1% 0% Metabolic/Nutritional Edema 1% 0% Product Monograph APO-MODAFINIL (Modafinil Tablets) Page 18 of 48 Modafinil n=934 (%) Placebo n=567 (%) Nervous Nervousness Insomnia Anxiety Dizziness Depression Paresthesia Somnolence Hypertonia Dyskinesia3 Hyperkinesia Agitation Confusion Tremor Emotional Lability Vertigo 7% 5% 5% 5% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 1% 3% 1% 1% 4% 1% 0% 1% 0% 0% 0% 0% 0% 0% 0% 0% Respiratory Rhinitis Pharyngitis Lung Disorder Epistaxis Asthma 7% 4% 2% 1% 1% 6% 2% 1% 0% 0% Skin/Appendages Sweating Herpes Simplex 1% 1% 0% 0% Special Senses Amblyopia Abnormal Vision Taste Perversion Eye Pain 1% 1% 1% 1% 0% 0% 0% 0% Urogenital Urine Abnormality Hematuria Pyuria 1% 1% 1% 0% 0% 0% * Six double-blind, placebo controlled clinical studies in narcolepsy (200 and 400 mg), OSA (200 and 400 mg) and SWD (200 mg and 300 mg).
, Alcohol Consumption, Risk of stroke 06/2023 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................... 1 Pediatrics ...................................................................................................................
2 Geriatrics ................................................................................................................... 5 2 CONTRAINDICATIONS .......................................................................................................
5 4 DOSAGE AND ADMINISTRATION ....................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment .......................................................... 5 Missed Dose .............................................................................................................. 7 5 OVERDOSAGE ...................................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING....................................... 8 7 WARNINGS AND PRECAUTIONS ........................................................................................ 1 Special Populations..................................................................................................
APO-MODAFINIL is contraindicated: • In patients who are hypersensitive to modafinil, armodafinil (the R- enantiomer of modafinil; not marketed in Canada) or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • In patients in agitated states and in patients with severe anxiety. • In women who are pregnant or may become pregnant. 1 Pregnant Women).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 Events reported by at least 1% of patients treated with modafinil tablets that were more frequent than in the placebo group are included; incidence is rounded to the nearest 1%. The adverse experience terminology is coded using a standard modified COSTART Dictionary.
Events for which the modafinil tablets incidence was at least 1%, but equal to or less than Product Monograph APO-MODAFINIL (Modafinil Tablets) Page 19 of 48 placebo are not listed in the table. These events included the following: abdominal pain, abnormal electrocardiogram, accidental injury, allergic reaction, arthritis, asthenia, bronchitis, cataplexy, conjunctivitis, dysmenorrhea4, dyspnea, ear pain, ecchymosis, fever, increased appetite, increased cough, infection, hyperglycemia, hypotension, hypothermia, leg cramps, migraine, myalgia, neck pain, pain, periodontal abscess, peripheral edema, rash, sinusitis, sleep disorder, thinking abnormality, tooth disorder, weight gain, weight loss, urinary tract infection, viral infection, vomiting.
2 Elevated liver enzymes. 3 Oro-facial dyskinesias. 4 Incidence adjusted for gender. 1 Clinical Trial Adverse Reactions – Pediatrics In the controlled and open-label clinical studies of pediatric patients with narcolepsy, transient leucopenia, which resolved without medical intervention, was observed.
In the controlled clinical study, 3 of 38 girls, ages 12 or older, treated with modafinil experienced dysmenorrhea compared to 0 of 10 girls who received placebo. Neuropsychiatric treatment-emergent adverse events have been reported in clinical trials of pediatric patients with narcolepsy, obstructive sleep apnea (OSA) or ADHD (see 7 WARNINGS AND PRECAUTIONS, Psychiatric).
Cases of serious skin reactions resulting in treatment discontinuation have been reported during clinical trials with pediatric patients (age < 17 years) (see 7 WARNINGS AND PRECAUTIONS, Skin). 7%). 0%). 0%). 7%). 3%). 3%). 3%). 3%). 3%). 3%).
Special […]
1 Pregnant Women ..................................................................................................... 2 Breast-feeding .........................................................................................................
3 Pediatrics ................................................................................................................. 4 Geriatrics ..................................................................................................................
16 8 ADVERSE REACTIONS ...................................................................................................... 1 Adverse Reaction Overview .....................................................................................
2 Clinical Trial Adverse Reactions ............................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics ............................................................ 3 Less Common Clinical Trial Adverse Reactions ........................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .................................................................................................... 5 Post-Market Adverse Reactions ..............................................................................
21 9 DRUG INTERACTIONS ...................................................................................................... 2 Drug Interactions Overview .....................................................................................
3 Drug-Behavioural Interactions................................................................................. 4 Drug-Drug Interactions ............................................................................................ 5 Drug-Food Interactions............................................................................................
6 Drug-Herb Interactions ............................................................................................ 7 Drug-Laboratory Test Interactions........................................................................... 25 10 CLINICAL PHARMACOLOGY .............................................................................................
1 Mechanism of Action ............................................................................................... 2 Pharmacodynamics .................................................................................................
3 Pharmacokinetics .................................................................................................... 27 11 STORAGE, STABILITY AND DISPOSAL ...............................................................................
29 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................ 29 PART II: SCIENTIFIC INFORMATION ........................................................................................
30 13 PHARMACEUTICAL INFORMATION ................................................................................. 30 14 CLINICAL TRIALS ..............................................................................................................
1 Clinical Trials by Indication ...................................................................................... 2 Comparative Bioavailability Studies......................................................................... 34 15 MICROBIOLOGY ..............................................................................................................
35 16 NON-CLINICAL TOXICOLOGY ........................................................................................... 35 17 […]