RAVIDA TABLET 200MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Ravidasvir hydrochloride

Boleh didapati daripada:

PHARMANIAGA MANUFACTURING BERHAD

INN (Nama Antarabangsa):

Ravidasvir hydrochloride

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

DOPPEL FARMACEUTICI S.R.L.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RAVIDA
® TABLET 200MG
Ravidasvir (200 mg)
CONFIDENTIAL
Page No. 1 of 3
WHAT IS IN THIS LEAFLET
1.
What Ravida is used for
2.
How Ravida works
3.
Before you use Ravida
4.
How to use Ravida
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Ravida
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT RAVIDA IS USED FOR
Ravida is an antiviral medicine
used to treat adults with long-
term (‘chronic’) hepatitis C (an
infectious disease that affects
the liver, caused by the hepatitis
C virus). It must always be used
together with other medicines
against hepatitis C infection and
must never be used by itself,
since it will not work on its
own.
Ravida
contains
the
active
substance
ravidasvir
(as
ravidasvir hydrochloride).
HOW RAVIDA WORKS
Ravida works by stopping the
hepatitis
C
virus
from
multiplying and infecting new
cells in the body. This allows
the infection to be eliminated
from the body.
BEFORE YOU USE RAVIDA
_When you must not use it _
•
If
you
are
allergic
to
ravidasvir or any of the other
ingredients in this medicine
(see
section
Product
Description)
•
If you are currently taking any
of the following medicines:
o
rifampicin
or
rifabutin
(antibiotics
used
to
treat
infections,
including
tuberculosis)
o
St.
John’s
wort
(herbal
medicine
traditionally
used
for insomnia)
o
carbamazepine,
phenobarbital and phenytoin
(medicines
used
to
treat
epilepsy and prevent seizures)
If you are not sure, talk to your
doctor
or
pharmacist
before
taking Ravida.
_Before you start to use it _
Talk
to
your
doctor
before
taking Ravida.
Tell your doctor if any of the
following applies:
•
you have a current or previous
infection
with
hepatitis
B
virus
•
you
have
been
previously
treated for hepatitis C
•
you
have
had
liver
organ
transplant
•
your liver is damaged and not
functioning properly
•
you have kidney problems
•
you have diabetes
•
you
suspect
or
have
been
diagnosed with HIV
_Blo

Ciri produk

FRONTE
10 mm
XX MM
110 MM
10 mm
10 mm
34 mm
10 mm
10 mm
12 mm
10 mm
12 mm
34 mm
PATIENT POPULATION
Patients without cirrhosis
Patients with compensated cirrhosis
REGIMEN AND DURATION
Ravida + sofosbuvir for 12 weeks
Ravida + sofosbuvir for 24 weeks
ANTIARRHYTHMICS
Interaction not studied.
Expected:
No dose adjustment of
Ravida or digoxin is
required.
Digoxin
Interaction not studied.
Expected:
↔ Ravidasvir
↔ Proton pump
inhibitor
Same class as
omeprazole and similar
interactions predicted.
Esomeprasole
Lansoprazole
Pantoprazole
Rabeprazole
(Increase in gastric pH)
Proton pump inhibitors
Interaction not studied.
Expected:
↓ Ravidasvir
↔ Famotidine
It is recommended that
H2-receptor antagonists
should be administered
4 hours after Ravida.
Famotidine
(Increase in gastric pH)
Interaction not studied.
Expected:
↓ Ravidasvir
↔ H2-receptor
antagonist
Interaction studied.
Observed:
↔ Ravidasvir
↔ Omeprazole
Same class as
famotidine and similar
interactions predicted.
Cimetidine
Nizatidine
Ranitidine
(Increase in gastric pH)
No dose adjustment of
Ravida or omeprazole
is required.
Omeprazole
(Increase in gastric pH)
H2-receptor antagonists
ANTICOAGULANTS
↔ Ravidasvir
↔ Digoxin
Caution
is
warranted
because of the narrow
therapeutic window of
digoxin.
Interaction not studied.
Expected:
↔ Ravidasvir
↔ Dabigatran etexilate
No dose adjustment of
Ravida or dabigatran
etexilate is required.
Caution is warranted
because of the narrow
therapeutic window of
dabigatran etexilate.
Dabigatran etexilate
Interaction not studied.
Close monitoring of
INR is recommended
with all vitamin K
antagonists. This is due
to liver function
changes during
treatment with Ravida.
Vitamin K antagonists
Losartan
ACID REDUCING AGENTS
Antacids
Interaction not studied.
Expected:
↔ Ravidasvir
↔ Losartan
No dose adjustment of
Ravida or losartan is
required.
Interaction not
studied.
Expected:
↓ Ravidasvir
↔ Antacid
It is recommended to
separate antacid use
and Ravida
administration by 4
hours.
Solubility of ravidasvir
decreases a