Ribavirine ratiopharm 200 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

RIBAVIRINE 200 mg/stuk

Beschikbaar vanaf:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC-code:

J05AP01

INN (Algemene Internationale Benaming):

RIBAVIRINE 200 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ribavirin

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

Ribavirin NL/H/2092/001, 15.07.2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
RIBAVIRINE RATIOPHARM 200 MG, FILMOMHULDE TABLETTEN
ribavirin
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] contains the active substance ribavirin. This medicine
stops the multiplication of
hepatitis C virus. [Product name] must not be used alone.
Depending on the genotype of the hepatitis C virus that you have, your
doctor 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 previously treated for
chronic hepatitis C infection. Your
doctor will recommend the best course of therapy.
The combination of [Product name] and other medicines is used to treat
adult patients who have
chronic hepatitis C (HCV).
[Product name] may be used in paediatric patients (children 3 years of
age and older and adolescents)
who are not previously treated and without severe liver disease.
For paediatric patients (children and adolescents) weighing less than
47 kg a solution formulation may
be available.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
2.
WHAT YOU NEED TO KNOW BEFOR

Productkenmerken

Ribavirin NL/H/2092/001-002, 15.07.2021
1
SUMMARY OF PRODUCT CHARACTERISTICS
Ribavirin NL/H/2092/001-002, 15.07.2021
2
1.
NAME OF THE MEDICINAL PRODUCT
Ribavirine ratiopharm 200 mg filmomhulde tabletten
Ribavirine ratiopharm 400 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of ribavirin.
400 mg
Each film-coated tablet contains 400 mg of ribavirin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Oval, biconvex, ivory film-coated tablets of 14 mm length and 7 mm
width.
400 mg
Oval, biconvex, yellow film-coated tablets of 18 mm length and 9 mm
width.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product name] is indicated in combination with other medicinal
products for the treatment of chronic
hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).
[Product name] 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 (see sections 4.2,
4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated, and monitored, by a physician
experienced in the management of
chronic hepatitis C.
Posology
[Product name] must be used in combination therapy as described in
section 4.1.
Please refer to the corresponding Summary of Product Characteristics
(SmPC) of medicinal products
used in combination with ribavirin for additional prescribing
information particular to that product and
for further dosage recommendations on co-administration with [Product
name].
[Product name] film-coated tablets are to be administered orally each
day in two divided doses
(morning and evening) with food.
_Adults _
The recommended dose and duration of [Product name] depends on
patient’s weight and on the
medicinal product that is used in combination. Please refer to the
corresponding SmPC of medicinal
products used in combination w