SOVALDI

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SOFOSBUVIR

Available from:

GILEAD SCIENCES ISRAEL LTD

ATC code:

J05AX15

Pharmaceutical form:

FILM COATED TABLETS

Composition:

SOFOSBUVIR 400 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GILEAD SCIENCES IRELAND UC, IRELAND

Therapeutic area:

SOFOSBUVIR

Therapeutic indications:

Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.For hepatitis C virus (HCV) genotype specific activity, see physician leaflet .

Authorization date:

2015-08-12

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS TO BE SUPPLIED BY DOCTOR’S PRESCRIPTION ONLY
SOVALDI
®
SOFOSBUVIR 400 MG
FILM
-
COATED TABLETS
ACTIVE INGREDIENTS:
Each tablet contains –
SOFOSBUVIR 400 MG
INACTIVE AND ALLERGENIC SUBSTANCES
: see section 6
_“Additional information”_
.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This leaflet contains essential information about this medicine. If
you have any further questions, ask your doctor or pharmacist. Keep
this leaflet. You may need to
read it again. 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.
This medicine is intended for adults aged 18 years and over.
HEPATITIS B VIRUS REACTIVATION:
BEFORE STARTING TREATMENT WITH SOVALDI, YOUR HEALTHCARE PROVIDER WILL
DO BLOOD TESTS TO
CHECK FOR HEPATITIS B VIRUS INFECTION. IF YOU HAVE OR HAD IN THE PAST
INFECTION WITH
HEPATITIS B VIRUS, SOVALDI MIGHT CAUSE REACTIVATION OF HEPATITIS B,
WHICH IN SOME CASES
MIGHT BY FATAL OR CAUSE SERIOUS LIVER PROBLEMS (SUCH AS LIVER
FAILURE).
REACTIVATION OF HEPATITIS B CAN OCCUR DURING TREATMENT OR AT THE END
OF TREATMENT WITH
SOVALDI. IF YOU ARE AT RISK OF HEPATITIS B REACTIVATION DURING OR
AFTER TREATMENT WITH
SOVALDI, YOU MUST BE CLOSELY MONITORED.
1.
WHAT IS SOVALDI INTENDED FOR?
Sovaldi contains the active substance sofosbuvir which is given to
treat hepatitis C virus infection in
adults of 18 years and older.
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
c

Summary of Product characteristics

1
THE FORMAT OF THIS LEAFLET WAS DEFINED BY THE MINISTRY OF HEALTH AND
ITS CONTENT WAS CHECKED AND
APPROVED BY THE MINISTRY OF HEALTH IN JANUARY 2018 AND UPDATED
ACCORDING TO THE GUIDELINES OF
THE MINISTRY OF HEALTH IN SEPTEMBER 2019.
SOVALDI
®
SOFOSBUVIR 400 MG
FILM
-
COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Sovaldi
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of sofosbuvir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, capsule-shaped, film-coated tablet of dimensions 20 mm x 9 mm,
debossed on one side with
“GSI” and “7977” on the other side.
4.
CLINICAL PARTICULARS
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS
COINFECTED WITH HCV AND HBV
TEST ALL PATIENTS FOR EVIDENCE OF CURRENT OR PRIOR HEPATITIS B VIRUS
(HBV) INFECTION
BEFORE INITIATING TREATMENT WITH SOVALDI. HBV REACTIVATION HAS BEEN
REPORTED IN
HCV/HBV COINFECTED PATIENTS WHO WERE UNDERGOING OR HAD COMPLETED
TREATMENT WITH
HCV DIRECT ACTING ANTIVIRALS AND WERE NOT RECEIVING HBV ANTIVIRAL
THERAPY. SOME
CASES HAVE RESULTED IN FULMINANT HEPATITIS, HEPATIC FAILURE, AND
DEATH. MONITOR
HCV/HBV COINFECTED PATIENTS FOR HEPATITIS FLARE OR HBV REACTIVATION
DURING HCV
TREATMENT AND POST-TREATMENT FOLLOW-UP. INITIATE APPROPRIATE PATIENT
MANAGEMENT FOR
HBV INFECTION AS CLINICALLY INDICATED.
4.1
THERAPEUTIC INDICATIONS
Sovaldi is indicated in combination with other medicinal products for
the treatment of chronic
hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
For hepatitis C virus (HCV) genotype specific activity, see sections
4.4 and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sovaldi treatment should be initiated and monitored by a physician
experienced in the management of
patients with CHC.
2
Posology
The recommended dose is one 400 mg tablet, taken orally, once daily
with food (see section 5.2).
Sovaldi should be used in combination with other medicinal products.
Monotherapy of Sovaldi is not
recommended (see section 5.1). R