BRIVIACT 100 MG FILM COATED TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BRIVARACETAM

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

N03AX23

Pharmaceutical form:

FILM COATED TABLETS

Composition:

BRIVARACETAM 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

UCB PHARMA S.A., BELGIUM

Therapeutic area:

BRIVARACETAM

Therapeutic indications:

Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.

Authorization date:

2022-12-31

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)- 1986
This medicine is to be supplied upon a physician's prescription only
BRIVIACT 10 MG FILM-COATED TABLETS
BRIVIACT 25 MG FILM-COATED TABLETS
BRIVIACT 50 MG FILM-COATED TABLETS
BRIVIACT 75 MG FILM-COATED TABLETS
BRIVIACT 100 MG FILM-COATED TABLETS
ACTIVE INGREDIENT:
Briviact 10 mg film-coated tablets contain brivaracetam 10 mg
Briviact 25 mg film-coated tablets contain brivaracetam 25 mg
Briviact 50 mg film-coated tablets contain brivaracetam 50 mg
Briviact 75 mg film-coated tablets contain brivaracetam 75 mg
Briviact 100 mg film-coated tablets contain brivaracetam 100 mg
For the list of excipients and allergens of the medicine, please see
section 2: “Important
information regarding some of the ingredients of the medicine” and
section 6: “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have any
further questions, contact
the physician or the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their medical condition is
similar.
This medicine is intended for adults, adolescents and children from 4
years of age.
1. WHAT IS THE MEDICINE INTENDED FOR
?
Briviact is used in adults, adolescents and children from 4 years of
age to treat a type
of epilepsy characterized by the occurrence of partial seizures with
or without
secondary generalisation.
Partial seizures are fits that start by only affecting one side of the
brain. These partial
seizures can spread and extend to larger areas on both sides of the
brain – this is
called a ‘secondary generalisation’.
You have been prescribed this medicine to lower the number of seizures
you have.
Briviact is used together with other medicines to treat epilepsy.
Therapeutic group: anti-epileptics.
2. BEFORE USING THIS MEDICINE
DO NOT TAKE BRIVIACT IF:
-
You are hypersensitive (all

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Briviact 10 mg film-coated tablets
Briviact 25 mg film-coated tablets
Briviact 50 mg film-coated tablets
Briviact 75 mg film-coated tablets
Briviact 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Briviact 10 mg film-coated tablets
Each film-coated tablet contains 10 mg brivaracetam.
Briviact 25 mg film-coated tablets
Each film-coated tablet contains 25 mg brivaracetam.
Briviact 50 mg film-coated tablets
Each film-coated tablet contains 50 mg brivaracetam.
Briviact 75 mg film-coated tablets
Each film-coated tablet contains 75 mg brivaracetam.
Briviact 100 mg film-coated tablets
Each film-coated tablet contains 100 mg brivaracetam.
Excipient(s) with known effect:
Briviact 10 mg film-coated tablets
Each 10 mg film-coated tablet contains 88 mg lactose.
Briviact 25 mg film-coated tablets
Each 25 mg film-coated tablet contains 94 mg lactose.
Briviact 50 mg film-coated tablets
Each 50 mg film-coated tablet contains 189 mg lactose.
Briviact 75 mg film-coated tablets
Each 75 mg film-coated tablet contains 283 mg lactose.
Briviact 100 mg film-coated tablets
Each 100 mg film-coated tablet contains 377 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Briviact 10 mg film-coated tablets
White to off-white, round film-coated tablets of 6.5 mm in diameter
and debossed with ‘u10’ on one
side.
2
Briviact 25 mg film-coated tablets
Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and
debossed with ‘u25’ on one
side.
Briviact 50 mg film-coated tablets
Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm
and debossed with ‘u50’ on
one side.
Briviact 75 mg film-coated tablets
Purple, oval film-coated tablets with dimensions of 13.0 mm x 7.3 mm
debossed with ‘u75’ on one
side.
Briviact 100 mg film-coated tablets
Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1
mm and debossed with ‘u100’
on one side.
4.
CLINICAL PARTI