Epclusa 400mg100mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Sofosbuvir; Velpatasvir

Sẵn có từ:

Gilead Sciences International Ltd

Mã ATC:

J05AP55

INN (Tên quốc tế):

Sofosbuvir; Velpatasvir

Liều dùng:

400mg ; 100mg

Dạng dược phẩm:

Tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 05030302

Tờ rơi thông tin

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPCLUSA 400 MG/100 MG FILM-COATED TABLETS
sofosbuvir/velpatasvir
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Epclusa is and what it is used for
2.
What you need to know before you take Epclusa
3.
How to take Epclusa
4.
Possible side effects
5.
How to store Epclusa
6.
Contents of the pack and other information
1.
WHAT EPCLUSA IS AND WHAT IT 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.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPCLUSA
DO NOT TAKE EPCLUSA
•
IF YOU ARE ALLERGIC
to sofosbuvir, velpatasvir or any of the other ingredients of this
medicine
(listed in section 6 of t

Đặc tính sản phẩm

OBJECT 1
EPCLUSA 400 MG/100 MG FILM COATED TABLETS.
Summary of Product Characteristics Updated 11-Jun-2018 | Gilead
Sciences Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 of dimensions 20 mm x 10 mm,
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 and 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 without cirrhosis and patients with
compensated cirrhosis
Epclusa for 12 weeks
Addition of ribavirin may be considered for genotype 3
infected patients with compensated cirrhosis (see section 5.1.)
Patients with decompensated cirrhosis
Epclusa + ribavirin for 12 weeks
a. Includes patients co-infected with human immunodeficiency virus
(HIV) and patients with recurrent
HCV post-liver transplant (see section 4.4.)_._
When used in combination with ribavirin, refer also to the Summary of
Product Characteristics of the
medicinal product containing ribavirin.
The following dosing is recommended where ribavirin is divided in two
daily doses and g