Harvoni 90mg400mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Ledipasvir; Sofosbuvir

Dostopno od:

Gilead Sciences International Ltd

Koda artikla:

J05AP51

INN (mednarodno ime):

Ledipasvir; Sofosbuvir

Odmerek:

90mg ; 400mg

Farmacevtska oblika:

Tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05030302

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HARVONI 90 MG/400 MG FILM-COATED TABLETS
ledipasvir/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 Harvoni is and what it is used for
2.
What you need to know before you take Harvoni
3.
How to take Harvoni
4.
Possible side effects
5.
How to store Harvoni
6.
Contents of the pack and other information
1.
WHAT HARVONI IS AND WHAT IT IS USED FOR
Harvoni is a medicine that contains the active substances ledipasvir
and sofosbuvir in a single tablet.
It is given to treat chronic (long-term) hepatitis C virus infection
in
ADULTS
and
ADOLESCENTS 12 TO LESS
THAN
18 YEARS
OF AGE
.
Hepatitis C is a virus that infects the liver. The active substances
in the 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.
Harvoni 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
Harvoni. If you have any questions about your medicines, please ask
your doctor or pharmacist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HARVONI
DO NOT TAKE HARVONI
•
IF YOU ARE ALLERGIC
to ledipasvir, sofosbuvir or any of the other ingredi

Lastnosti izdelka

OBJECT 1
HARVONI 90 MG/400 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 28-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
Harvoni 90 mg/400 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 90 mg ledipasvir and 400 mg
sofosbuvir.
Excipients with known effect:
Each film-coated tablet contains 156.8 mg of lactose (as monohydrate)
and 261 micrograms of sunset
yellow FCF aluminium lake.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Orange, diamond-shaped, film-coated tablet of dimensions 19 mm x 10
mm, debossed with “GSI” on one
side and “7985” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Harvoni is indicated 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
Harvoni treatment should be initiated and monitored by a physician
experienced in the management of
patients with CHC.
Posology
_Adults and adolescents aged 12 to < 18 years _
The recommended dose of Harvoni is one tablet once daily with or
without food (see section 5.2).
TABLE 1: RECOMMENDED TREATMENT DURATION FOR HARVONI AND THE
RECOMMENDED USE OF CO-
ADMINISTERED RIBAVIRIN FOR CERTAIN SUBGROUPS
PATIENT POPULATION
(including HIV co-infected patients)
TREATMENT AND DURATION
_Adult and Adolescent patients 12 years of age or older with genotype
1, 4, 5 or 6 CHC_
Patients without cirrhosis
Harvoni for 12 weeks.
- Harvoni for 8 weeks may be considered in previously
untreated genotype 1-infected patients (see section 5.1, ION-3
study).
Patients with c