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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