Epclusa (sofosbuvir 400mg velpatasvir 100mg) Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SOFOSBUVIR; Velpatasvir

Boleh didapati daripada:

Gilead Sciences Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

SOFOSBUVIR; Velpatasvir

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

Gilead Sciences Ireland UC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
EPCLUSA
® FILM-COATED TABLETS
SOFOSBUVIR 400MG / VELPATASVIR 100MG
1
WHAT IS IN THIS LEAFLET?
1.
What Epclusa is used for
2.
How Epclusa works
3.
Before you take Epclusa
4.
How to use Epclusa
5.
While you are using
Epclusa
6.
Side effects
7.
Storage and disposal of
Epclusa
8.
Product description
9.
Manufacturer and
Product Registration
Holder
10.
Date of Revision
1.
WHAT EPCLUSA IS USED FOR
Epclusa is a medicine that
contains the active substances
sofosbuvir and velpatasvir in a
single tablet. It is given to treat
a chronic (long-term) viral
infection of the liver called
hepatitis C in adults of 18 years
and older.
2.
HOW EPCLUSA WORKS
The active substances in this
medicine work together by
blocking two different proteins
that the virus needs to grow
and reproduce itself, allowing
the infection to be permanently
eliminated from the body.
Epclusa is sometimes taken
with another medicine,
ribavirin.
It is very important that you
also read the leaflets for the
other medicines that you will
be taking with Epclusa. If you
have any questions about your
medicines, please ask your
doctor or pharmacist.
3.
BEFORE YOU TAKE EPCLUS
_ _
_When you must not use it _
DO NOT TAKE EPCLUSA
•
IF YOU ARE ALLERGIC
to
sofosbuvir, velpatasvir or
any of the other
ingredients of this
medicine (listed in
section 8 of this leaflet).
→
If this applies to you,
DO
NOT TAKE EPCLUSA AND TELL
YOUR DOCTOR IMMEDIATELY.
•
IF YOU ARE CURRENTLY
TAKING ANY OF THE
FOLLOWING MEDICINES:
•
RIFAMPICIN
and
RIFABUTIN
(antibiotics
used to treat
infections, including
tuberculosis);
•
ST. JOHN’S WORT
–
herbal medicine used
to treat depression;
•
CARBAMAZEPINE
,
PHENOBARBITAL
and
PHENYTOIN
(medicines
used to treat epilepsy
and prevent seizures).
_Before you start to use it _
WARNINGS AND PRECAUTIONS
Talk to your doctor if you:
•
HAVE LIVER PROBLEMS
other
than from hepatitis C, for
instance
•
IF YOU HAVE A CURRENT
OR PREVIOUS INFECTION
WITH THE HEPATITIS B
VIRUS,
since your
doctor may want to

Ciri produk

1
EPCLUSA
®
(sofosbuvir/velpatasvir 400 mg/100 mg film-coated tablets for oral
use)
FULL PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Epclusa 400 mg/100 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg sofosbuvir and 100 mg
velpatasvir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, diamond-shaped, film-coated tablet debossed on one side with
“GSI” and “7916” on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epclusa is indicated for the treatment of chronic hepatitis C virus
(HCV) infection in adults (see
sections 4.2, 4.4 and 5.1).
4.2
POSOLOGY & METHOD OF ADMINISTRATION
Epclusa treatment should be initiated and monitored by a physician
experienced in the management of
patients with HCV infection.
Posology
The recommended dose of Epclusa is one tablet, taken orally, once
daily with or without food (see
section 5.2).
TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR ALL HCV GENOTYPES
PATIENT POPULATION
A
TREATMENT AND DURATION
Patients with genotype 1, 2, 3, 4, 5 or 6 HCV
Patients without cirrhosis and patients with
compensated cirrhosis
Epclusa for 12 weeks
Patients with genotype 1 or 3 HCV
Patients with decompensated cirrhosis
Epclusa + ribavirin
b
for 12 weeks
a.
Includes patients co-infected with human immunodeficiency virus (HIV).
b.
When administered with Epclusa, the recommended dosage of ribavirin is
based on weight (administered with
food); 1000 mg per day for patients less than 75kg and 1200 mg for
those weighing at least 75kg, divided and
administered twice daily. The starting dosage and on-treatment dosage
of ribavirin can be decreased based on
haemoglobin and creatinine clearance. For ribavirin dosage
modifications, refer to the package insert of medicinal
products containing ribavirin.
Patients should be instructed that if vomiting occurs within 3 hours
of dosing an additional tablet of
Epclusa should be taken. If vomiting occurs more than 3 hours aft