Copegus film coated tablet 200mg

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

RIBAVIRIN

Verfügbar ab:

ROCHE (MALAYSIA) SDN. BHD.

INN (Internationale Bezeichnung):

RIBAVIRIN

Einheiten im Paket:

00168Tablet Tablets; 0042Tablet Tablets

Hergestellt von:

PATHEON INC

Gebrauchsinformation

COPEGUS
® FILM-COATED TABLET
Ribavirin (200mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Copegus is used for
2.
How Copegus works
3.
Before you use Copegus
4.
How to use Copegus
5.
While you are using Copegus
6.
Side effects
7.
Storage and disposal of Copegus
8.
Product Description
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT COPEGUS IS USED FOR
Copegus contains the active ingredient
_ribavirin_
.
COPEGUS IS USED TO TREAT HEPATITIS C (A
VIRAL INFECTION OF THE LIVER).
Copegus is
not effective if used alone in the
treatment of hepatitis C and must be
used in combination with interferon
alfa or peginterferon alfa injections.
Refer also to the package leaflets of the
other medicines that are used in
combination with Copegus.
HOW COPEGUS WORKS
The medicine contained within
Copegus, ribavirin, belongs to a group
of medicines called antivirals.
It works by inhibiting the
multiplication of hepatitis C viruses.
If the viral infection is not managed
effectively, the liver becomes badly
damaged and scarring may occur in
some people. This is known as
cirrhosis.
BEFORE YOU USE COPEGUS
_When you must not take it_
Do not take Copegus if:
1.
You are allergic to ribavirin or any
of the ingredients listed at the end of
this leaflet.
Some of the symptoms of an allergic
reaction may include:
- shortness of breath
- wheezing or difficulty in breathing
- feeling faint
- swelling of the face, lips, tongue or
other parts of the body
- rashes, itching, hives on the skin
2.
You are pregnant, or plan to become
pregnant, or your female partner is
pregnant (if you are male)
There is an extremely high risk of
causing harm to your unborn baby if
you take Copegus during pregnancy.
You must use effective contraception to
avoid becoming pregnant while taking
Copegus as well as 6 months after
treatment.
3.
You are breastfeeding or plan to
start breastfeeding.
It is not known whether Copegus passes
into breast milk.
Breastfeeding must stop before
treatment of Copegus begins. Do

Fachinformation

PACK INSERT FOR MALAYSIA
COPEGUS
®
RIBAVIRIN


1. DESCRIPTION
1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Direct acting antiviral
1.2 TYPE OF DOSAGE FORM
Supplied as a 200mg film-coated tablet for oral administration.
COPEGUS film-coated tablets are light pink to pink flat oval tablets
containing
200 mg of ribavirin. The tablets are engraved "ROCHE" on one side and
"RIB
200" on the other side.
1.3 ROUTE OF ADMINISTRATION
oral
1.4 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: ribavirin_
Each 200 mg film-coated tablet contains 200 mg of ribavirin.
2. CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATIONS
Copegus is indicated, in combination with peginterferon alfa-2a or
interferon alfa-
2a for the treatment of chronic hepatitis C in previously untreated
adult patients
and who are positive for serum HCV RNA, including patients with
compensated
cirrhosis.
Copegus
in
combination
with
peginterferon
alfa-2a
is
also
indicated
for
the
treatment of patients who have failed previous treatment with
interferon alpha
(pegylated or non-pegylated) alone or in combination therapy with
ribavarin.
Demonstrated efficacy included HCV patients co-infected with
clinically stable
HIV.
Please refer to the label of peginterferon alfa-2a or interferon
alfa-2a products for
additional information.
2.2 DOSAGE AND METHOD OF ADMINISTRATION
Copegus is used in combination with peginterferon alfa-2a or
interferon alfa-2a.
The exact dose and duration of treatment depend on the interferon
product used.
Please refer to the label of peginterferon alfa-2a or interferon
alfa-2a for further
information on dosage and the duration of treatment when Copegus
is given in
combination with either of these products.
IN COMBINATION WITH PEGASYS (PEGINTERFERON ALFA-2A)
The daily dose and duration of Copegus given in combination with
Pegasys should
be individualized based on the patient’s viral genotype and body
weight (see Table
1). The daily dose of Copegus is to be administered orally in two
divided doses
(morning and evening) with food.
_CHRON