COPEGUS 200 MG FILM-COATED TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
RIBAVIRIN
Available from:
PCO Manufacturing
Dosage:
200 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2007-07-06
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Copegus 200 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 milligrams of ribavirin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK and France:_
Light pink, oval-shaped film-coated tablets (marked with 'RIB 200' on one side and 'ROCHE' on the opposite side).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Copegus is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen
with peginterferon alfa-2a or with interferon alfa-2a. Copegus monotherapy must not be used.
The combination of Copegus with peginterferon alfa-2a or interferon alfa-2a is indicated in adult patients with elevated
transaminases and who are positive for serum HCV-RNA, including patients with compensated cirrhosis (See section
4.4). The combination with peginterferon alfa-2a is also indicated in patients co-infected with clinically stable HIV,
including patients with compensated cirrhosis (See section 4.3). The combination regimens are indicated in previously
untreated patients as well as in patients who have previously responded to interferon alpha therapy and subsequently
relapsed after treatment was stopped.
Please refer to the Summary of Product Characteristics (SPC) of peginterferon alfa-2a or interferon alfa-2a for
prescribing information particular to either of these products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C.
METHOD OF ADMINISTRATION
Copegus tablets are administered orally in two divided doses with food (morning and evening). The tablets should not
Read the complete document
