HARVONI (Ledipasvir 90mgSofosbuvir 400mg) Film-coated Tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

SOFOSBUVIR; Ledipasvir

Boleh didapati daripada:

Gilead Sciences Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

SOFOSBUVIR; Ledipasvir

Unit dalam pakej:

28tablet Tablets

Dikeluarkan oleh:

Gilead Sciences Ireland UC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
HARVONI
®
FILM-COATED TABLETS
Ledipasvir (90 mg) and Sofosbuvir (400mg)
1
WHAT IS IN THIS LEAFLET?
1.
What Harvoni is used for
2.
How Harvoni works
3.
Before you use Harvoni
4.
How to use Harvoni
5.
While you are using
Harvoni
6.
Side effects
7.
Storage and disposal
of
Harvoni
8.
Product Description
9.
Manufacturer &
Product
Registration
Holder
10.
Date of Revision
WHAT HARVONI IS USED FOR
Harvoni
®
is a prescription
medicine used to treat
chronic
(long-term) hepatitis
C virus
infection in adults of
18 years
and older.
HOW HARVONI WORKS
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.
BEFORE YOU USE HARVONI
_-When you must not use it_
_ _
DO NOT TAKE HARVONI
•
IF YOU ARE ALLERGIC
to
ledipasvir, sofosbuvir or any
of the other ingredients of
this
medicine (Refer to the
Product Description section
of this leaflet).
→
If this applies to you,
DO
NOT TAKE HARVONI AND TELL
YOUR DOCTOR IMMEDIATELY.
•
IF YOU ARE CURRENTLY
TAKING
ANY OF THE
FOLLOWING
MEDICINES:
•
RIFAMPICIN AND
RIFABUTIN
(antibiotics
used to treat infections,
including tuberculosis);
•
ST. JOHN’S WORT
(herbal
medicine used to
treat
depression);
•
CARBAMAZEPINE,
PHENOBARBITAL AND
PHENYTOIN
(medicines used to
treat epilepsy and
prevent seizures);
•
ROSUVASTATIN
(a
medicine used to
treat
high
cholesterol).
_-Before you start use it_
_ _
WARNINGS AND PRECAUTIONS
Your doctor will know if any of
the following conditions apply
to
you. These will be
considered
before treatment
with Harvoni is
started.
•
OTHER LIVER PROBLEMS
apart
from hepa

Ciri produk

1
HARVONI ® (ledipasvir/ sofosbuvir) tab lets, for oral use
FULL PRESCRIBING INFORMATION
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 ledipas vir and 400 mg sofosbuvir .
Excipients with known effect:
Each film -coated tablet contains 156.8 mg of lactose (as monohydrate ) and 261 micr ograms 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 PARTICUL ARS
4.1 Therapeutic indications
Harvoni is indicated for the treatment o f 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
Harvoni treatment should be initiated and monitored by a ph ysician experienced in the management of
patients with CHC.
Posology
The recommended dose of Harvoni is one tablet once daily with or without food (see section 5.2) .