Emtricitabine/Tenofovirdisoproxil DOC Generici, 200 mg/245 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

EMTRICITABINE 200 mg/stuk ; TENOFOVIRDISOPROXILSUCCINAAT 300,6 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk

Beschikbaar vanaf:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

ATC-code:

J05AR03

INN (Algemene Internationale Benaming):

EMTRICITABINE 200 mg/stuk ; TENOFOVIRDISOPROXILSUCCINAAT 300,6 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tenofovir Disoproxil And Emtricitabine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYVINYLALCOHOL (E1203); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2016-05-11

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
EMTRICITABINE/TENOFOVIRDISOPROXIL DOC GENERICI, 200 MG/245 MG
FILMOMHULDE TABLETTEN
emtricitabine/tenofovir disoproxil
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 EMTRICITABINE/TENOFOVIR DISOPROXIL DOC Generici is and what it is
used for
2.
What you need to know before you take EMTRICITABINE/TENOFOVIR
DISOPROXIL DOC
Generici
3.
How to take EMTRICITABINE/TENOFOVIR DISOPROXIL DOC Generici
4.
Possible side effects
5.
How to store EMTRICITABINE/TENOFOVIR DISOPROXIL DOC Generici
6.
Contents of the pack and other information
1.
WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL DOC GENERICI IS AND WHAT IT IS
USED FOR
EMTRICITABINE/TENOFOVIR DISOPROXIL DOC GENERICI CONTAINS TWO ACTIVE
SUBSTANCES,
_emtricitabine _
and
_tenofovir disoproxilsuccinate_
. Both of these active substances are
_antiretroviral _
medicines
which are used to treat HIV infection. Emtricitabine is a
_nucleoside reverse transcriptase inhibitor _
and
tenofovir is a
_nucleotide reverse transcriptase_
_inhibitor. _
However, both are generally known as NRTIs and
they work by interfering with the normal working of an enzyme (reverse
transcriptase) that is essential for the
virus to reproduce itself.
•
EMTRICITABINE/TENOFOVIR DISOPROXIL DOC GENERICI IS USED TO TREAT HUMAN
IMMUNODEFICIENCY VIRUS 1 (HIV-1) INFECTION IN ADULTS.
•
IT IS ALSO USED TO TREAT HIV IN ADOLESCENTS AGED 12 TO LESS THAN 18
YEARS WHO WEIGH AT LEAST 35
KG,
and who have already been treated with other HIV medicines that are no
longe

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovirdisoproxil DOC Generici, 200 mg/245 mg
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of
tenofovir disoproxil (equivalent to
300.6 mg of tenofovir disoproxil succinate).
Excipient with known effect:
Each tablet contains 96 mg lactose monohydrate and sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue coloured, capsule shaped film-coated tablets, plain on both
sides. The dimensions of the
tablets are 19.3 mm x 8.8 mm ± 5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of HIV-1 infection:_
EMTRICITABINE/TENOFOVIR DISOPROXIL DOC Generici is indicated in
antiretroviral combination
therapy for the treatment of HIV-1 infected adults (see section 5.1).
EMTRICITABINE/TENOFOVIR DISOPROXIL DOC Generici is also indicated for
the treatment of HIV-1
infected adolescents, with NRTI resistance or toxicities precluding
the use of first line agents (see sections 4.2,
4.4 and 5.1).
_Pre-exposure prophylaxis (PrEP): _
EMTRICITABINE/TENOFOVIR DISOPROXIL DOC Generici is indicated in
combination with safer sex
practices for pre-exposure prophylaxis to reduce the risk of sexually
acquired HIV-1 infection in adults and
adolescents at high risk (see sections 4.2, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
EMTRICITABINE/TENOFOVIR
DISOPROXIL
DOC
Generici
should
be
initiated
by
a
physician
experienced in the management of HIV infection.
Posology
Treatment
_of HIV in adults and adolescents aged 12 years and older, weighing at
least 35 kg: _
One tablet, once
daily.
_Prevention of HIV in adults and adolescents aged 12 years and older,
weighing at least 35 kg: _
One tablet, once
daily.
Separate preparations of emtricitabine and tenofovir disoproxil are
available for treatment of HIV-1 infection
if
it
becomes
necessary
to
discontinue
or
modify
the
dose
of
one
of
the
components
of
EMTRICITABINE/TENOFOVIR DISOPROXIL DOC Gen