Sovaldi 400mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Sofosbuvir

Предлага се от:

Gilead Sciences International Ltd

АТС код:

J05AP08

INN (Международно Name):

Sofosbuvir

дозиране:

400mg

Лекарствена форма:

Tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 05030302; GTIN: 5391507140890

Листовка

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOVALDI 400 MG FILM-COATED TABLETS
sofosbuvir
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 Sovaldi is and what it is used for
2.
What you need to know before you take Sovaldi
3.
How to take Sovaldi
4.
Possible side effects
5.
How to store Sovaldi
6.
Contents of the pack and other information
1.
WHAT SOVALDI IS AND WHAT IT IS USED FOR
Sovaldi contains the active substance sofosbuvir which is given to
treat hepatitis C virus infection in
adults and adolescents from the age of 12 years up to the age of 18
years.
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. 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOVALDI
DO NOT TAKE SOVALDI

If you are allergic to sofosbuvir or any of the other ingredients of
this medicine (li

Данни за продукта

OBJECT 1
SOVALDI 400 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 27-Sep-2017 | 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
Sovaldi 400 mg film-coated tablets
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
4.1 Therapeutic indications
Sovaldi is indicated in combination with other medicinal products for
the treatment of chronic hepatitis C
(CHC) in adults and in adolescents aged 12 to <18 years (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.
Posology
_Adults _
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). Refer also to the Summary of Product
Characteristics of the medicinal
products that are used in combination with Sovaldi. The recommended
co-administered medicinal
product(s) and treatment duration for Sovaldi combination therapy are
provided in Table 1.
TABLE 1: RECOMMENDED CO-ADMINISTERED MEDICINAL PRODUCT(S) AND
TREATMENT DURATION FOR ADULTS
TREATED WITH SOVALDI COMBINATION THERAPY
PATIENT POPULATION*
TREATMENT
DURATION
Patients with genotype 1, 4, 5
or 6 CHC
Sovaldi + ribavirin + peginterferon alfa
12 weeks
a,b
Sovaldi + rib