Leaflet STIRIPENTOL BILLEV 250mg powder for oral suspension

Indicated for: epilepsy

Route of administration: oral

Substance: stiripentol (antiepileptic)

ATC: N03AX17 (Nervous system | Antiepileptics | Other antiepileptics)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Suicidal ideation / mental changes
Suicidal ideation / mental changes

Seek medical help if suicidal thoughts or major behavior changes occur.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Stiripentol is an antiepileptic medication used as adjunctive therapy for the treatment of Dravet syndrome, a rare form of epilepsy. It works by enhancing the effects of other antiepileptic drugs, such as clobazam and valproate, and by reducing neuronal excitability.

The medication is taken orally, as directed by a doctor, usually two or three times daily. It is important for patients to adhere to the treatment regimen and avoid abrupt discontinuation.

Patients should be aware of potential side effects, such as drowsiness, nausea, or decreased appetite. It is important to inform the doctor of any unusual symptoms.

Common side effects include drowsiness, nausea, and decreased appetite. In rare cases, severe reactions such as neutropenia or allergic reactions may occur. Patients should be informed of these risks before starting treatment.

General data about STIRIPENTOL BILLEV 250mg

  • Substance: stiripentol
  • Date of latest medicines list: 01-12-2024
  • Product code: W70726001
  • Concentration: 250mg
  • Pharmaceutical form: powder for oral suspension
  • Quantity: 30
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: MISOM LABS LIMITED - MALTA
  • Holder: BILLEV PHARMA APS - DANEMARCA
  • Number: 15689/2024/01
  • Shelf life: 3 years

Pharmaceutical forms available for stiripentol

Concentrations available for stiripentol

  • 250mg
  • 500mg