Emtricitabine/ Tenofovirdisoproxil Apotex 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 Archimedesweg 2 2333 CN LEIDEN

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/ TENOFOVIRDISOPROXIL APOTEX 200 MG/245 MG,
FILMOMHULDE TABLETTEN – RVG 118545
MODULE 1.3
Product Information
Version: 2019-04
MODULE 1.3.1
Patient Information Leaflet
Replaces: 2017-09
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EMTRICITABINE/ TENOFOVIRDISOPROXIL APOTEX 200 MG/245 MG, FILMOMHULDE
TABLETTEN
EMTRICITABINE/TENOFOVIRDISOPROXIL
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 is and what it is used
for
2.
What you need to know before you take Emtricitabine/ Tenofovir
disoproxil Apotex
3.
How to take Emtricitabine/ Tenofovir disoproxil Apotex
4.
Possible side effects
5.
How to store Emtricitabine/ Tenofovir disoproxil Apotex
6.
Contents of the pack and other information
1.
WHAT EMTRICITABINE/ TENOFOVIR DISOPROXIL APOTEX IS AND WHAT IT IS USED
FOR
EMTRICITABINE/ TENOFOVIR DISOPROXIL APOTEX 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 APOTEX IS USED TO TREAT HUMAN
IMMUNODEFICIENCY
VIRUS 1 (HIV-1) INFECTION, in adults aged.

IT IS ALSO USED TO TR

Productkenmerken

1
Emtricitabine/ Tenofovirdisoproxil Apotex 200 mg/245 mg,
MODULE 1.3
Product Information
Version: 2020-02
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2019-09
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Emtricitabine/ Tenofovirdisproxil Apotex 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 is indicated in
antiretroviral combination therapy for
the treatment of HIV-1 infected adults (see section 5.1)
Emtricitabine/ Tenofovir disoproxil Apotex 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 Apotex 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 4.4 and 5.1).
2
Emtricitabine/ Tenofovirdisoproxil Apotex 200 mg/245 mg,
MODULE 1.3
Product Information
Version: 2020-02
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2019-09
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Emtricitabine/ Tenofovir disoproxil Apotex should be initiated by a
physician experienced in the
management of HIV infection.
Posology
_Treatment or prevention of HIV in adults _
_and adolescents aged 12 years and older, weighing at _
_least 3