Olysio

País: União Europeia

Língua: inglês

Origem: EMA (European Medicines Agency)

Ingredientes ativos:

simeprevir

Disponível em:

Janssen-Cilag International NV

Código ATC:

J05AE14

DCI (Denominação Comum Internacional):

simeprevir

Grupo terapêutico:

Antivirals for systemic use

Área terapêutica:

Hepatitis C, Chronic

Indicações terapêuticas:

Olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.For hepatitis C virus (HCV) genotype specific activity.

Resumo do produto:

Revision: 13

Status de autorização:

Withdrawn

Data de autorização:

2014-05-14

Folheto informativo - Bula

47
B. PACKAGE LEAFLET
Medicinal product no longer authorised
48
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLYSIO 150 MG HARD CAPSULES
simeprevir
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What OLYSIO is and what it is used for
2.
What you need to know before you take OLYSIO
3.
How to take OLYSIO
4.
Possible side effects
5.
How to store OLYSIO
6.
Contents of the pack and other information
1.
WHAT OLYSIO IS AND WHAT IT IS USED FOR
WHAT OLYSIO IS
-
OLYSIO contains the active substance ‘simeprevir’. It acts against
the virus that causes
hepatitis C infection, called ‘hepatitis C virus’ (HCV).
-
OLYSIO must not be used by itself. OLYSIO must always be used as part
of a course of
treatment with other medicines for treating chronic hepatitis C
infection. It is therefore
important that you also read the package leaflets that are provided
with these other medicines
before you start taking OLYSIO. If you have any further questions
about any of these
medicines, ask your doctor or pharmacist.
WHAT OLYSIO IS USED FOR
OLYSIO is used with other medicines to treat chronic (long-term)
hepatitis C infection in adults.
HOW OLYSIO WORKS
OLYSIO helps to fight against hepatitis C infection by preventing HCV
from multiplying. When used
together with other medicines to treat chronic h

Características técnicas

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
OLYSIO 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains simeprevir sodium equivalent to 150 mg of
simeprevir.
Excipient with known effect: each capsule contains 78.4 mg of lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule)
White gelatin capsule of approximately 22 mm in length, marked with
“TMC435 150” in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OLYSIO is indicated in combination with other medicinal products for
the treatment of chronic
hepatitis C (CHC) in adult patients (see sections 4.2, 4.4 and 5.1).
For hepatitis C virus (HCV) genotype specific activity, see sections
4.4 and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with OLYSIO should be initiated and monitored by a physician
experienced in the
management of CHC.
Posology
The recommended dosage of OLYSIO is one capsule of 150 mg once daily,
taken with food.
OLYSIO must be used in combination with other medicinal products for
the treatment of CHC (see
section 5.1). When considering OLYSIO combination treatment with
peginterferon alfa and ribavirin
in HCV genotype 1a patients, patients should be tested for the
presence of virus with the NS3 Q80K
polymorphism before starting treatment (see section 4.4).
Refer also to the Summary of Product Characteristics of the medicinal
products that are used in
combination with OLYSIO.
The recommended co-administered medicinal product(s) and treatment
duration for OLYSIO
combination therapy are provided in tables 1 and 2.
Medicinal product no longer authorised
3
TABLE 1:
RECOMMENDED TREATMENT DURATION FOR