Rebetol
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-11-2023
Charakterystyka produktu
(SPC)
07-11-2023
Sprawozdanie z oceny publicznego
(PAR)
07-11-2023
Składnik aktywny:
Ribavirin
Dostępny od:
Merck Sharp and Dohme B.V
Kod ATC:
J05AP01
INN (International Nazwa):
ribavirin
Grupa terapeutyczna:
Antivirals for systemic use, Antivirals for treatment of HCV infections
Dziedzina terapeutyczna:
Hepatitis C, Chronic
Wskazania:
Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.
Podsumowanie produktu:
Revision: 39
Status autoryzacji:
Withdrawn
Data autoryzacji:
1999-05-06
Ulotka dla pacjenta
65
PACKAGE LEAFLET:
INFORMATION FOR THE USER
REBETOL 200 MG HARD CAPSULES
ribavirin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION
FOR YOU.
-
Ke
ep this leaflet. You may need to read
it again.
-
If you have any
further questions, ask your d
octor, pharmacist or nurse.
-
This medicine has bee
n prescribed for you only. Do
not pass it on to others. It ma
y harm them,
even if their signs of illness are the s
ame as yours.
-
If
you get any
side effects talk to your doctor, pharmacist or nurse. This includes
any possible
side ef
fects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Re
betol is and what it is used for
2.
What you need to
know before you use Rebetol
3.
How to use Rebetol
4.
Possible side effects
5.
How to store R
ebetol
6.
Contents of the
pack and other informat
ion
1.
WHAT REBETOL IS AND WHAT IT IS USED FOR
Rebetol contains the active substance ribavirin. This medicine s
tops the multiplication of hepatitis
C
virus. Rebetol must not be used alone.
Depending on t
he genotype of the hepatitis
C virus that you hav
e, your doc
tor may choose to
treat you
with a combination of
this medicine with
other medicines. There may be some
further treatment
limitations if you
have or have not been pre
viously treated for chronic he
patitis C infection. Your
doctor will recommend t
he best course of therapy.
T
he combination of
Rebetol and other medicines is used to treat adult patients who have
chronic
hepatitis C (HCV).
Rebetol may be used in paediatric
patients (children 3
years of age and older and adoles
cents) who are
not previously treat
ed and without
severe liver disease.
For paediatric patients (
children and adolescents
) weighing less than 47
kg a solution formulation is
available.
If yo
u have an
y further questions on the use
of this medicine,
ask yo
ur doctor or pharmacist.
2.
WHAT
YOU NEED TO KNOW B
EFORE YOU USE REBETOL
DO NOT TAKE REBETOL
Do not take Rebetol i
f any of the following apply to
you or the chil
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Rebetol 200
mg hard capsu
les
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each har
d capsule contains 200
mg of ribavirin.
Excipient
with known eff
ect
Each
hard capsule contains 40
mg of lactose monohydrate.
For the
full list of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Hard capsule (capsule)
White, opaque and imprinted w
ith blue ink.
4.
CLIN
ICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rebetol is indicated in com
bination with other medicinal products for the treatment of chronic
hepatitis
C (CHC) in adults (see
sections
4.2, 4.4, and 5.1).
Rebetol is indicated in com
bination with other me
d
icinal products for
the treatment of chronic
hepatitis C (CHC) for paediat
ric patients (children 3
years of age and older and adolescents) not
previously treated and without
liver decompensation
(see sections
4.2, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tre
atment should be initiated
, and monitored, by a physici
an experienced in the management of
chronic hepatitis C.
Posology
Rebetol must be used in combinat
ion therapy as described in section
4.1.
Please refer to th
e corresponding Summar
y
of Product Charact
eristics (SmPC)
of medicinal products
used in combinati
on with Rebetol for additional prescribing information particular to
that product and
for further do
sage recommendations on co
-
administration with
Rebetol.
Re
betol capsules are to
b
e administered oral
ly each day in two divided
doses (morning and evening)
with food.
Adults
The
recommended
dose and duration of Rebetol depends on patient
’s
weight and on
the medicinal
product that is used in combination
. Please refer to the corresponding
SmPC of medicina
l products
used in combina
tion with Rebetol.
In the ca
ses in which no specific dose recommendation is made, the following
dose should be used:
Patient weight: < 75 kg =1,000 mg and > 75 kg = 1,200 mg.
Medicinal product no longer authorised
3
Paediatric popul
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