Briviact (in Italy: Nubriveo)

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Brivaracetam

Διαθέσιμο από:

UCB Pharma SA

Φαρμακολογική κατηγορία (ATC):

N03AX23

INN (Διεθνής Όνομα):

brivaracetam

Θεραπευτική ομάδα:

Antiepileptics,

Θεραπευτική περιοχή:

Epilepsy

Θεραπευτικές ενδείξεις:

Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy.

Περίληψη προϊόντος:

Revision: 22

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2016-01-13

Φύλλο οδηγιών χρήσης

99
B. PACKAGE LEAFLET
100
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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
brivaracetam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Briviact is and what it is used for
2.
What you need to know before you take Briviact
3.
How to take Briviact
4.
Possible side effects
5.
How to store Briviact
6.
Contents of the pack and other information
1.
WHAT BRIVIACT IS AND WHAT IT IS USED FOR
WHAT BRIVIACT IS
Briviact contains the active substance brivaracetam. It belongs to a
group of medicines called
‘anti-epileptics’. These medicines are used to treat epilepsy.
WHAT BRIVIACT IS USED FOR
•
Briviact is used in adults, adolescents and children from 2 years of
age.
•
It is used to treat a type of epilepsy that has partial seizures with
or without a 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 given this medicine to lower the number of fits
(seizures) you have.
•
Briviact is used together with other medicines for epilepsy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRIVIACT
DO NOT TAKE BRIVIACT IF:
-
you are allergic to brivaracetam, other similar chemical compounds as
levetiracetam or
piracetam or any of the oth

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
3.
PHARMACEUTICAL FORM
Film-coated tablet (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.
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