Briviac, 25 mg 56 pcs.

Epilepsy Briviac is indicated as adjunctive therapy in the treatment of partial seizures with or without secondary generalization in adults and adolescents from 16 years of age with epilepsy.

Indications

Briviac is indicated as an adjunctive therapy in the treatment of partial seizures with or without secondary generalization in adults and adolescents over 16 years of age with epilepsy.

Pharmacological effect

PHARMACOTHERAPEUTIC GROUP:

Special instructions

Withdrawal of the drug

Active ingredient

Brivaracetam

Composition

Active ingredient:

brivaracetam 25.00 mg;

Excipients:

croscarmellose sodium 5.00 mg,

lactose monohydrate 48.50 mg,

Betadex 6.75 mg,

lactose anhydrous 48.25 mg,

magnesium stearate 1.50 mg,

film coating Opadry II 85F275014 gray 6.75 mg (polyvinyl alcohol, talc, polyethylene glycol 3350 / macrogol 3350, titanium dioxide, iron oxide yellow, iron oxide black).

Pregnancy

Pregnancy
Risk associated with epilepsy and antiepileptic drugs

Contraindications

Hypersensitivity to the active substance or other pyrrolidone derivatives, as well as to any of the auxiliary components listed in the “Composition” section.
Children under 16 years of age (due to lack of clinical data).
Rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
End-stage renal failure requiring hemodialysis (due to lack of clinical data).
PRECAUTIONS FOR APPLICATION

Side Effects

Security Profile Summary
The safety of Briviac was assessed in 2388 patients, of whom 1740 received brivaracetam for >6 months, 1363 for >12 months, 923 for >24 months, and 569 for >60 months (5 years).

Interaction

Drug-drug interaction studies have been conducted in adults only.

Overdose

Clinical experience with brivaracetam overdose in humans is limited. Healthy volunteers taking a single dose of 1400 mg brivaracetam experienced drowsiness and dizziness.

Storage conditions

Store at a temperature not exceeding 30 °C. Keep out of the reach of children.

Shelf life

3 years.

Manufacturer

UCB Farma, Belgium