Provigil 100mg Tablet

    Provigil 100mg Tablet

    S5
    PDF Leaflet Revision Date: 5 October 2007

    API: Modafinil | Company: Litha Pharma

    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Improves wakefulness in excessive daytime sleepiness associated with narcolepsy.

    Dosage (summary)

    200 mg/day as a single morning dose; reduce in elderly and hepatic impairment.

    Onset of Action / Duration

    Onset: 2-4 hours, Duration: ~15 hours

    Special Populations

    • Elderly
    • Hepatic impairment
    • Renal impairment

    Pregnancy & Breastfeeding

    Safety not established; caution advised during pregnancy and lactation.

    Key Drug Interactions

    • CYP2C19 substrates (e.g., diazepam, phenytoin)
    • CYP3A4 substrates (e.g., hormonal contraceptives)
    • Tricyclic antidepressants

    Contraindications

    • Hypersensitivity to modafinil
    • Major anxiety
    • Children under 16
    • Severe renal impairment

    Common side effects

    • Headache
    • Nausea
    • Anxiety
    • Insomnia

    Counselling Points

    • Avoid alcohol while taking PROVIGIL
    • Notify doctor if pregnant or breastfeeding
    • Discuss all medications with doctor due to interaction potential

    Serious warnings

    • Monitor blood pressure in hypertensive patients
    • Risk of psychosis in predisposed individuals
    Important Disclaimer

    The Provigil 100mg Tablet professional information leaflet below is the property of Litha Pharma and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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