Sovaldi 400mg Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SOFOSBUVIR

Boleh didapati daripada:

Gilead Sciences Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

SOFOSBUVIR

Unit dalam pakej:

28tablet Tablets

Dikeluarkan oleh:

Gilead Sciences Ireland UC

Risalah maklumat

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SOVALDI
_®_ 400 MG FILM-COATED TABLETS_ _
SOFOSBUVIR (400MG)
1
WHAT IS IN THIS LEAFLET?
1.
What Sovaldi is used for
2.
How Sovaldi works
3.
Before you use Sovaldi
4.
How to use Sovaldi
5.
While you are using
Sovaldi
6.
Side effects
7.
Storage and Disposal of
Sovaldi
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT SOVALDI IS USED FOR
SOVALDI contains the active
substance sofosbuvir which is
given to treat hepatitis C virus
infection in adults of 18 years
and older.
HOW SOVALDI WORKS
Hepatitis C is a virus that infects
the liver. This medicine works
by lowering the amount of
hepatitis C virus in your body
and removing the virus from
your blood over a period of
time.
SOVALDI is always taken with
other medicines to treat hepatitis
C. It will not work on its own.
It is commonly taken with
either:
•
Ribavirin, or
•
Peginterferon alfa and
ribavirin
It is very important that you also
read the leaflets for the other
medicines that you will be
taking with SOVALDI. If you
have any questions about your
medicines, please ask your
doctor or pharmacist.
BEFORE YOU USE SOVALDI
_When you must not use it:_
Do not take SOVALDI
•
If you are allergic to
sofosbuvir or any of the
other ingredients of this
medicine (Refer to the
Product Description
section of this leaflet).
→
If this applies to you, tell
your doctor immediately.
•
IF YOU ARE CURRENTLY
TAKING ANY OF THE
FOLLOWING MEDICINES:
o
RIFAMPICIN
(antibiotic
used to treat infections,
including tuberculosis);
o
ST. JOHN’S WORT
(herbal
medicine used to treat
depression);
o
CARBAMAZEPINE,
PHENOBARBITAL AND
PHENYTOIN
(medicines
used to treat epilepsy and
prevent seizures).
_Before you start to use it _
WARNINGS AND PRECAUTIONS
SOVALDI is always taken with
other medicines to treat hepatitis
C (see section above). Talk to
your doctor or pharmacist
before taking this medicine if
you:
•
Currently take, or have
taken in the last few
months, the medicine
amiodarone to treat
irr

Ciri produk

1
SOVA\b I ®(sofosbuvir) tablets, for oral use
FU\b\b PRESCRIBING INFORMATION
1. NAME OF THE MEDICINA\b T
Sov•b
i ®400 mg film -co•b
\bblets
2. QUA\b
$$
! *!$
$$
 COMPOSITION
E•b m -co•b
\bblet cont•b 400 mg of sofosbuvir .
For the full list of excipients, see section 6.1.
3. PHARMACEUTICA\b FORM
Film -co•b
\bblet.
Yellow , c•b e -sh•b  m -co•b
\bblet of dimensions 20 mm x 9mm, debossed on one side with
“GSI” •b “7977” on the other side .
4. C\b
!
\b PARTICU\b ARS
4.1 Therapeutic indications
Sov•b
i is indic•b in combin•b$ medicin•b 
s for the tre•b
hep•bs C (CHC) in •b
 s (see sections 4.2, 4.4 •bd 5.1) .
For hep•bs C virus ( HCV )genotype specific •b2 s 4.4 •b
0".
4.2 Posology and method of administration
Sov•b
i tre•b
\bted •b

2\b physici•b
\bn•b
p•b$,.,.
Posology
The recommended dose is one 400 mg t•b  \bken or•b 2 
\bily with food (see section 5.2) .
Sov•b
i should be used in combin•b$ medicin•b 
s . Monother•b2\bldi is not
recommended (see section 5.1). Refer •b  Summ•b23
,\br•bs of the
medicin•b 
\bt •b
\btion with Sov•b
i . The reco mmended co -•b
ministered
medicin•b 
-) •b
\btment dur•b Sov•b
i combin•b\bpy •be provided in T•b e 1.