Oseltamivir Zentiva 75 mg harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

OSELTAMIVIRFOSFAAT 98,5 mg/stuk SAMENSTELLING overeenkomend met ; OSELTAMIVIR 75 mg/stuk

Beschikbaar vanaf:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

INN (Algemene Internationale Benaming):

OSELTAMIVIRFOSFAAT 98,5 mg/stuk SAMENSTELLING overeenkomend met ; OSELTAMIVIR 75 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-04-22

Bijsluiter

Oseltamivir hard capsules NL_en_NL-H-4650_del BRS Wessling 202312
PACKAGE LEAFLET: INFORMATION FOR THE USER
OSELTAMIVIR ZENTIVA 75 MG HARDE CAPSULES
oseltamivir
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
•
is used for adults, adolescents, children and infants
(including full-term newborn
babies) for
TREATING FLU
(
_influenza_
). It can be used when you have flu symptoms, and the flu virus is
known to be going round in your community.
•
can also be prescribed for adults, adolescents,
children and infants above 1 year of
age for
PREVENTING FLU,
on a case-by-case basis – for instance, if you have been in contact
with
someone who has flu.
•
may be prescribed for adults, adolescents, children and
infants (including full-term
newborn babies) as
PREVENTIVE TREATMENT
in exceptional circumstances – for example, if there is a
global epidemic of flu (a flu
_pandemic_
) and the seasonal flu vaccine may not provide sufficient
protection.
contains
_oseltamivir_
, which belongs to a group of medicines named
_neuraminidase _
_inhibitors_
. These medicines prevent the flu virus from spreading inside the
body. They help to ease or
prevent the symptoms of th

Productkenmerken

Oseltamivir hard capsules NL_en_NL-H-4650_name
change_2020_07_EPAR_2020_07
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Oseltamivir Zentiva 30 mg harde capsules
Oseltamivir Zentiva 45 mg harde capsules
Oseltamivir Zentiva 75 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
30 mg hard capsules
Each hard capsule contains oseltamivir phosphate equivalent to 30 mg
of oseltamivir.
45 mg hard capsules
Each hard capsule contains oseltamivir phosphate equivalent to 45 mg
of oseltamivir.
75 mg hard capsules
Each hard capsule contains oseltamivir phosphate equivalent to 75 mg
of oseltamivir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
30 mg hard capsules
Size “4” hard gelatin capsules with light yellow opaque colour
body with black colour band, imprinted with
“M” and light yellow opaque colour cap imprinted with “30 mg”.
The size is approximately 14.37 mm.
45 mg hard capsules
Size “4” hard gelatin capsules with grey opaque colour body with
black colour band, imprinted with “M”
and grey opaque colour cap imprinted with “45 mg”. The size is
approximately 14.37 mm.
75 mg hard capsules
Size “2” hard gelatin capsules with grey opaque colour body with
black colour band, imprinted with “M”
and light yellow opaque colour cap imprinted with “75 mg”. The
size is approximately 17.66 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of influenza _
Oseltamivir is indicated in adults and children including full term
neonates who present with symptoms
typical of influenza, when influenza virus is circulating in the
community. Efficacy has been demonstrated
when treatment is initiated within two days of first onset of
symptoms.
_Prevention of influenza _
-
Post-exposure prevention in individuals 1 year of age or older
following contact with a clinically
diagnosed influenza case when influenza virus is circulating in the
community.
-
T