Leaflet BRIVARACETAM ACCORD 25mg film-coated tablets

Product code:
W71428001
Quantity:
14
Indicated for:
epilepsy
Route of administration:
oral
Substance:
brivaracetam (antiepileptic)
ATC
N03AX23 — Nervous system | Antiepileptics | 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.

Brivaracetam is a medication used for the treatment of epilepsy, specifically focal seizures with or without secondary generalization, in patients aged 4 years and older. It is an antiepileptic drug that works by binding to the synaptic vesicle protein SV2A, reducing neuronal excitability.

The medication is administered orally or intravenously, as directed by a doctor. The dosage is adjusted based on the patient's age, weight, and response to treatment.

Common side effects include drowsiness, dizziness, fatigue, and irritability. In rare cases, more severe adverse effects such as depression or suicidal thoughts may occur, requiring close monitoring of patients.

Brivaracetam is not recommended for pregnant or breastfeeding women unless the benefits outweigh the risks. Patients should inform their doctor about all medications they are taking to avoid drug interactions.

General data about BRIVARACETAM ACCORD 25mg

Substance:
brivaracetam
Date of latest medicines list:
01-11-2025
Product code:
W71428001
Concentration:
25mg
Pharmaceutical form:
film-coated tablets
Quantity:
14
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:
HOLSTEN PHARMA GMBH - GERMANIA
Holder:
ACCORD HEALTHCARE POLSKA SP. Z O.O. - POLONIA
Number:
16272/2025/01
Shelf life:
3 years

Pharmaceutical forms available for brivaracetam

Concentrations available for brivaracetam

  • 100mg
  • 10mg
  • 10mg/ml
  • 25mg
  • 50mg
  • 75mg