GRATEZIANO 400 MG FILM COATED TABLET

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

Sofosbuvir

Verfügbar ab:

PHARMANIAGA LOGISTICS SDN. BHD.

INN (Internationale Bezeichnung):

Sofosbuvir

Einheiten im Paket:

28 Tablets

Hergestellt von:

European Egyptian for Pharmaceutical Industries Co.

Gebrauchsinformation

_Consumer Medication Information Leaflet (RiMUP) _
GRATEZIANO 400 MG FILM COATED TABLET
Sofosbuvir (400 mg)
1
WHAT IS IN THIS LEAFLET
1.
What GRATEZIANO is used for
2.
How GRATEZIANO works
3.
Before you use GRATEZIANO
4.
How to use GRATEZIANO
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
GRATEZIANO
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT GRATEZIANO IS USED FOR
GRATEZIANO is used in combination
with
other
medicine
for
treatment
of
hepatitis C virus infection in adults.
HOW GRATEZIANO WORKS
GRATEZIANO
contains
sofosbuvir,
a
medicine
that
treat
hepatitis
C
virus
infection.
It
works
by
lowering
the
amount of hepatitis C virus in the body
and removing the virus from the blood
over a period of time.
GRATEZIANO is commonly taken with
either ribavirin or peginterferon alfa and
ribavirin.
BEFORE YOU USE GRATEZIANO_ _
-
_When you must not use it _
If
allergic
(hypersensitive)
to
the
sofosbuvir
or
to
any
of
the
other
ingredients of GRATEZIANO.
_ _
If you are taking any of the following
medicines:
•
Rifampin
(antibiotic
used
to
treat
bacterial
infection
including
tuberculosis)
•
St.
John’s
wort
(Hypericum
perforatum – herbal medicine used to
treat depression)
•
Carbamazepine,
phenobarbital
and
phenytoin
(medicine
used
to
treat
epilepsy and prevent seizures)
If
_ _
you are not sure whether you should
start taking this medicine, talk to your
doctor or pharmacist.
_ _
-
_Before you start to use it _
Discuss with your doctor or pharmacist
if:
•
You are taking amiodarone (medicine
used
to
treat
and
prevent
irregular
heartbeats.
•
You
have
a
current
or
previous
hepatitis B infection.
•
You have liver problem.
•
You have diabetis.
_Pregnancy and lactation _
Do
not
take
GRATEZIANO
with
ribavirin if you are pregnant, trying to
get
pregnant
or
think
you
may
be
pregnant. Ribavirin may cause damage to
unborn baby. Extreme caution must be
taken to avoid pregnancy while taking
this combination.
Do not take GRATEZIANO if you are
breast-feeding

Fachinformation

The pharmacokinetics of drugs that are metabolized by the liver (e.g.
immunosuppressive agents such as calcineurin inhibitors) may be
impacted by changes in liver function during DAA therapy, related to
clearance of HCV.
Other interactions
Drug interaction information for GRATEZIANO with potential concomitant
medicinal products is summarized in Table 3 below (where
90% confidence interval (CI) of the geometric least-squares mean
(GLSM) ratio were within “
↔
”, extended above “
↑
”, or extended
below “
↓
” the predetermined equivalence boundaries). The table is not
all-inclusive.
TABLE 3: INTERACTIONS BETWEEN GRATEZIANO AND OTHER MEDICINAL PRODUCTS MEDICINAL PRODUCT BY
THERAPEUTIC AREAS
MEAN RATIO (90% CONFIDENCE
INTERVAL) FOR
AUC, C
MAX
, C
MINA,B
RECOMMENDATION CONCERNING CO-ADMINISTRATION
WITH GRATEZIANO
_ANALEPTICS_
Modafinil
Interaction not studied.
_Expected:_
↓
Sofosbuvir
↔
GS-331007
(Induction of P-gp)
Co-administration of GRATEZIANO with modafinil is expected to decrease
the
concentration of sofosbuvir, leading to reduced therapeutic effect of
GRATEZIANO. Such
co-administration is not recommended.
_ANTIARRHYTHMICS_
Amiodarone
Interaction not studied
Use only if no other alternative is available. Close monitoring is
recommended if this
medicinal product is administered with GRATEZIANO (see sections 4.4
and 4.8).
_ANTICOAGULANTS_
Vitamin K antagonists
Interaction not studied
Close monitoring of INR is recommended with all vitamin K antagonists.
This is due to
liver function changes during treatment with GRATEZIANO.
_ANTICONVULSANTS_
Phenobarbital
Phenytoin
Interaction not studied.
_Expected:_
↓
Sofosbuvir
↔
GS-331007
(Induction of P-gp)
GRATEZIANO is contraindicated with phenobarbital and phenytoin (see
section 4.3).
Carbamazepine
_Sofosbuvir_
↓
C
max
0.52 (0.43, 0.62)
↓
AUC 0.52 (0.46, 0.59)
C
min
(NA)
GS 331007
↔
C
max
1.04 (0.97,1.11)
↔
AUC 0.99 (0.94, 1.04)
C
min
(NA)
(Induction of P-gp)
GRATEZIANO is contraindicated with carbamazepine (see section 4.3).
Oxcarbazepine
I