Emtricitabine/ Tenofovirdisoproxil Apotex Europe BV 200 mg/245 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

EMTRICITABINE ; TENOFOVIRDISOPROXILFUMARAAT SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL ; SAMENSTELLING overeenkomend met TENOFOVIR

Beschikbaar vanaf:

Apotex Europe BV

ATC-code:

J05AR03

INN (Algemene Internationale Benaming):

EMTRICITABINE ; TENOFOVIRDISOPROXILFUMARAAT COMPOSITION corresponding to ; TENOFOVIRDISOPROXIL ; COMPOSITION corresponding to TENOFOVIR

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSPOVIDON (E 1202) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 0-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tenofovir Disoproxil And Emtricitabine

Product samenvatting:

Hulpstoffen: CROSPOVIDON (E 1202); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 0-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-09-26

Bijsluiter

EMTRICITABINE/ TENOFOVIR DISOPROXIL APOTEX EUROPE BV 200
MG/245 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version: 2017-08-18
MODULE 1.3.1
Patient Information Leaflet
Replaces : 2016-09
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EMTRICITABINE/ TENOFOVIR DISOPROXIL APOTEX EUROPE BV 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 Apotex Europe BV is and what
it is used for
2.
What you need to know before you take Emtricitabine/ Tenofovir
disoproxil Apotex Europe
BV
3.
How to take Emtricitabine/ Tenofovir disoproxil Apotex Europe BV
4.
Possible side effects
5.
How to store Emtricitabine/ Tenofovir disoproxil Apotex Europe BV
6.
Contents of the pack and other information
1.
WHAT EMTRICITABINE/ TENOFOVIR DISOPROXIL APOTEX EUROPE BV IS AND WHAT
IT IS USED FOR
EMTRICITABINE/ TENOFOVIR DISOPROXIL APOTEX EUROPE BV CONTAINS TWO
ACTIVE SUBSTANCES,
_emtricitabine _
_and _
_tenofovir _
_disoproxil_.
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 IS USED TO TREAT HUMAN
IMMUNODEFICIEN

Productkenmerken

EMTRICITABINE/ TENOFOVIR DISOPROXIL APOTEX EUROPE BV 200
MG/245 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version: 2017 08 18
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2017-03
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Emtricitabine/ Tenofovir disoproxil Apotex Europe BV 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 mg of tenofovir disoproxil fumarate or 136 mg of
tenofovir).
Excipient(s) with known effect:
Each tablet contains 40 mg Anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, capsule shaped, biconvex coated tablet with dimensions of 7.49
mm x 16.26 mm. Engraved
“APO” on one side “E-T” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of HIV-1 infection: _
Emtricitabine/ Tenofovir disoproxil Apotex Europe BV is indicated in
antiretroviral combination
therapy for the treatment of HIV-1 infected adults (see section 5.1)
Emtricitabine/ Tenofovir disoproxil Apotex Europe BV is also indicated
for the treatment of HIV-
1 infected adolescents, with NRTI resistance or toxicities precluding
the use of first line agents,
aged 12 to < 18 years (see section 5.1).
_Pre-exposure prophylaxis (PrEP): _
Emtricitabine/ Tenofovir disoproxil Apotex Europe BV is indicated in
combination with safer sex
practices for pre-exposure prophylaxis to reduce the risk of sexually
acquired HIV-1 infection in
adults at high risk (see sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
EMTRICITABINE/ TENOFOVIR DISOPROXIL APOTEX EUROPE BV 200
MG/245 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version: 2017 08 18
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2017-03
2
Emtricitabine/ Tenofovir disoproxil Apotex Europe BV should be
initiated by a physician
experienced in the management of HIV infection.
Po