Copegus 200mg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ribavirin

Available from:

F. Hoffmann-La Roche Ltd. Wurmisweg CH-4303 Kaiseraugust-batch releaser

ATC code:

J05AB04

INN (International Name):

ribavirin

Dosage:

200mg

Pharmaceutical form:

tablets film-coated

Units in package:

(42) plastic container, (168) plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-02-06

Patient Information leaflet

COPEGUS
®
Ribavirin
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Direct-acting antiviral.
1.2
TYPE OF DOSAGE FORM
Supplied as an oval-shaped film-coated tablet for oral
administration.
1.3
ROUTE OF ADMINISTRATION
Oral.
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
Each film-coated tablet contains 200 mg of
ribavirin.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
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 ribavirin. 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 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.
_CHRONIC HEPATITIS C_
The duration of combination therapy with ribavirin for chronic
hepatitis C depends on viral genotype. Patients infected with HCV
genotype 1 who have detectable HCV RNA at week 4
regardless
of pre-treatment vi

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Copegus 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of ribavirin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Light pink, flat oval-shaped film-coated tablet (marked with RIB 200
on one side and ROCHE on the
opposite side).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Copegus is indicated in combination with other medicinal products, for
the treatment of chronic
hepatitis C (CHC).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated, and monitored, by a physician
experienced in the management of
chronic hepatitis C.
Refer also to the SmPC of the medicinal products that are used in
combination with Copegus for the
treatment of hepatitis C.
METHOD OF ADMINISTRATION
Copegus film-coated tablets are administered orally in two divided
doses with food (morning and
evening). Due to the teratogenic potential of ribavirin, the tablets
should not be broken or crushed.
POSOLOGY
DOSE TO BE ADMINISTERED
The dose of Copegus is based on patient body weight, _viral genotype
and the medicinal product that is _
_used in combination _ (see Table1). Copegus tablets are to be
administered orally each day in two
divided doses (morning and evening) with food.
_ _
Table 1. Copegus dosing recommendation according to the medicinal
product used in combination
MEDICINAL PRODUCT USED IN COMBINATION
DAILY COPEGUS DOSE
NUMBER OF 200/400MG TABLETS
Direct acting antivirals (DAA)
<75kg=1000mg

75 kg = 1200 mg
5 x 200 mg
(2 morning, 3 evening)
6 x 200 mg
(3 morning, 3 evening)
PegIFN alfa-2a _WITH DAA_
<75kg=1000mg
5 x 200 mg
(2 morning, 3 evening)
3

75 kg = 1200 mg
6 x 200 mg
(3 morning, 3 evening)
PegIFN alfa-2a _WITHOUT DAA_
GENOTYPE 2/3 TREATMENT-NAÏVE
GENOTYPE 2/3/4 WITH HIV-COINFECTION
800mg
4 x 200 mg
(2 morning, 2 evening)
or
2 x 400 mg
(1 morning, 1 evening)
GENOTYPE 1/4
GENOTYPE 2/3 TREATMENT-EXPERIENCED
GENOTYPE 1