Exviera 250mg Film Coated Tablets

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

Dasabuvir Sodium Monohydrate

Verfügbar ab:

ABBVIE SDN BHD

INN (Internationale Bezeichnung):

Dasabuvir Sodium Monohydrate

Einheiten im Paket:

56 Tablets

Hergestellt von:

Abbvie Ireland NL B.V

Gebrauchsinformation

_Consumer Medication Information Leaflet (RiMUP)_
EXVIERA™ FILM-COATED TABLETS
Dasabuvir 250 mg
_____________________________________________________________________________________
WHAT IS IN THIS LEAFLET
1. What Exviera™ is used for
2. How Exviera™ works
3. Before you take Exviera™
4. How to take Exviera™
5. While you are using
Exviera™
6. Side effects of Exviera™
7. Storage and disposal of
Exviera™
8. Product description
9. Manufacturer and Product
Registratin H
older
10. Date of revision
11. Serial number
WHAT EXVIERA™ IS USED FOR
Exviera™ is an antiviral
medicine used to treat
adults with chronic
(long-term) Hepatitis C (an
infectious disease that affects
the liver, caused
by the Hepatitis C virus).
It is very important that you
also read the package leaflets
for the other antiviral
medicines that you take with
Exviera™. If you have any
questions about your
medicines, please ask your
doctor or pharmacist.
HOW EXVIERA™ WORKS
It contains the active substance
dasabuvir. Exviera™ works by
stopping the Hepatitis C virus
from multiplying and infecting
new cells, thus clearing the
virus from your blood over a
period of time.
Exviera™ tablets do not work
on their own. They are always
taken with another antiviral
medicine containing
ombitasvir/paritaprevir/ritona
vir. Some patients may also
take an antiviral medicine
called ribavirin. Your doctor
will talk with you about
which of these medicines to
take with Exviera™.
BEFORE YOU TAKE EXVIERA™
_When you must not take _
_Exviera™_
•
If you are allergic to
dasabuvir or any of the
other ingredients of this
medicine (refer to list of
ingredients).
•
If you have moderate to
severe liver problems
other than Hepatitis C.
•
If you are taking any of
the medicines listed in the
following table. This is
because serious or
life-
threatening
effects can occur
when Exviera and
ombitasvir/paritaprevir/riton
avir are taken with these
medicines.
These medicines can affect the
way Exviera and
ombitasvir/paritaprevir/ritonav
ir work and Exviera an

Fachinformation

1
Product Package Insert
Product Name
Dasabuvir 250mg
Trade Name
Exviera 250 mg film-coated tablets
Description and Composition
Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate). The
tablet is beige, ovaloid, film-coated tablets with dimensions of 14.0 mm x 8.0 mm,
debossed on one side with ‘AV2’.
Excipients for tablet : Microcrystalline cellulose, Lactose monohydrate,
Copovidone, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate.
Excipients for film-coating : Polyvinyl alcohol , Titanium dioxide, Polyethylene
glycol
3350, Talc, Iron oxide yellow, Iron oxide red, Iron oxide
black.
Excipient with known effect : each film-coated tablet contains 44.94 mg lactose
(as monohydrate). This product does not contain gluten.
Indication and Usage
Exviera is indicated in combination with other medicinal products for the treatment of
chronic hepatitis C (CHC) in adults (see sections Dosage and Administration, Special
Warnings and Precautions and Pharmacodynamic Properties).
For hepatitis C virus (HCV) genotype specific activity, see sections Special Warnings
and Precautions and Pharmacodynamic Properties.
Dosage and Administration
Treatment with Exviera should be initiated and monitored by a physician experienced
in the management of chronic hepatitis C.
Posology
The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and
evening). Exviera must not be administered as monotherapy. Exviera should be used
in combination with other medicinal products for the treatment of HCV (see section
Pharmacodynamic properties). Refer to the package insert of the medicinal products
that are used in combination with Exviera.
The recommended co-administered medicinal product(s) and treatment duration
for Exviera combination therapy are provided in table 1.