Epclusa
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
14-08-2023
Valmisteyhteenveto
(SPC)
14-08-2023
Julkisesta arviointikertomuksesta
(PAR)
18-01-2022
Aktiivinen ainesosa:
Sofosbuvir, velpatasvir
Saatavilla:
Gilead Sciences Ireland UC
ATC-koodi:
J05A
INN (Kansainvälinen yleisnimi):
sofosbuvir, velpatasvir
Terapeuttinen ryhmä:
Antivirals for systemic use
Terapeuttinen alue:
Hepatitis C, Chronic
Käyttöaiheet:
Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).
Tuoteyhteenveto:
Revision: 22
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2016-07-06
Pakkausseloste
78
B. PACKAGE LEAFLET
79
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPCLUSA 400 MG/100 MG FILM-COATED TABLETS
EPCLUSA 200 MG/50 MG FILM-COATED TABLETS
sofosbuvir/velpatasvir
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
IF EPCLUSA HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
THE INFORMATION IN THIS LEAFLET
IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
1.
WHAT EPCLUSA IS AND WHAT IT IS USED FOR
Epclusa is a medicine that contains the active substances sofosbuvir
and velpatasvir. Epclusa is given
to treat chronic (long-term) hepatitis C virus infection in adults and
children aged 3 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.
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 this leaflet).
If this applies to you,
DO NOT TAKE
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Epclusa 400 mg/100 mg film-coated tablets
Epclusa 200 mg/50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Epclusa 400 mg/100 mg film-coated tablets
Each film-coated tablet contains 400 mg sofosbuvir and 100 mg
velpatasvir.
Epclusa 200 mg/50 mg film-coated tablets
Each film-coated tablet contains 200 mg sofosbuvir and 50 mg
velpatasvir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Epclusa 400 mg/100 mg film-coated tablets
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.
Epclusa 200 mg/50 mg film-coated tablets
Pink, oval-shaped, film-coated tablets of dimensions 14 mm x 7 mm,
debossed on one side with “GSI”
and “S/V” 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 patients 3 years
of age and older (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 in adults is one 400 mg/100 mg tablet,
taken orally, once daily
with or without food (see section 5.2).
The recommended dose of Epclusa in paediatric patients aged 3 years
and above is based on weight as
detailed in Table 3.
A granule formulation of Epclusa is available for the treatment of
chronic HCV infection in paediatric
patients aged 3 years and above having difficulty swallowing
film-coated tablets. For patients
3
weighing < 17 kg, please refer to the Summary of Product
Characteristics for Epclusa 200 mg/50 mg
or 150 mg/37.5 mg granules.
TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR ADULTS REGARDLESS OF
HCV GENOTYPES
ADULT PATIENT POPULATION
A
TREATMENT AND DURATION
Patients without cirrhosis and patients with
compensate
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