Prolert 100 & 200 100 mg or 200 mg Tablets

    Prolert 100 & 200 100 mg or 200 mg Tablets

    S5
    PDF Leaflet Revision Date: 06.2023

    API: Modafinil | Company: Abex Pharmaceutica

    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Improves wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

    Dosage (summary)

    200 mg once daily in the morning; consider dose reduction in elderly and hepatic impairment.

    Special Populations

    • Elderly
    • Hepatic impairment
    • Renal impairment

    Pregnancy & Breastfeeding

    Not recommended during pregnancy or breastfeeding; may reduce effectiveness of contraceptives.

    Key Drug Interactions

    • Anticonvulsants
    • Steroidal contraceptives
    • Antidepressants
    • Anticoagulants

    Contraindications

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

    Common side effects

    • Headache
    • Nausea
    • Insomnia
    • Anxiety
    • Dizziness

    Counselling Points

    • Monitor for rash and psychiatric symptoms
    • Maintain good sleep hygiene
    • Use effective contraception

    Serious warnings

    • Serious rash (SJS, TEN, DRESS)
    • Psychiatric symptoms
    • Cardiovascular risks
    • Potential for abuse
    Important Disclaimer

    The Prolert 100 & 200 100 mg or 200 mg Tablets professional information leaflet below is the property of Abex Pharmaceutica 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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