Emtricitabine/Tenofovirdisoproxil Hetero 200/245 mg filmomhulde tabletten

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

EMTRICITABINE ; TENOFOVIRDISOPROXIL

Tilgængelig fra:

Hetero Europe S.L. Viladecans Business Park, Edificio Brasil, Catalunya 83-85 08840 VILADECANS (SPANJE)

ATC-kode:

J05AR03

INN (International Name):

EMTRICITABINE ; TENOFOVIRDISOPROXIL

Lægemiddelform:

Filmomhulde tablet

Sammensætning:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; TITAANDIOXIDE (E 171),

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Tenofovir Disoproxil And Emtricitabine

Produkt oversigt:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; TITAANDIOXIDE (E 171);

Autorisation dato:

2017-07-17

Indlægsseddel

1 PACKAGE LEAFLET: INFORMATION FOR THE USER
EMTRICITABINE/TENOFOVIRDISOPROXIL HETERO 200/245 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 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 or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Emtricitabine/Tenofovir disoproxil Hetero is and what it is used
for
2.
What you need to know before you take Emtricitabine/Tenofovir
disoproxil Hetero
3.
How to take Emtricitabine/Tenofovir disoproxil Hetero
4.
Possible side effects
5.
How to store Emtricitabine/Tenofovir disoproxil Hetero
6.
Contents of the pack and other information
1.
WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL HETERO IS AND WHAT IT IS USED
FOR
Emtricitabine/Tenofovir disoproxil Hetero 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 Hetero is used to treat Human
Immunodeficiency Virus 1
(HIV-1) infection, in adults aged 18 years and over.

Emtricitabine/Tenofovir disoproxil Hetero should always be used
combined with other
medicines to treat HIV infection.

Emtricitabine/Tenofovir disoproxil Hetero can be administered in place
o

Produktets egenskaber

Emtricitabine/Tenofovir disoproxil film-coated tablets 200/245 mg
Module 1.3.1 Page 1 of 28
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovirdisoproxil Hetero 200/245 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 136 mg of tenofovir).
Excipient(s) with known effect: Each tablet contains 227.20 mg Lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, capsule shaped, film-coated tablets with a dimension of
approximate 19.20 mm in
length and approximate 8.70 mm in width debossed with 'H' on one side
and 'E29' on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of HIV-1 infection: _
Emtricitabine/Tenofovir disoproxil Hetero is indicated in
antiretroviral combination therapy
for the treatment of HIV-1 infected adults(see section 5.1).
_Pre-exposure prophylaxis (PrEP):_
Emtricitabine/Tenofovir
disoproxil
Hetero
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 Hetero should be initiated by a
physician experienced in
the management of HIV infection.
Posology
_Treatment or prevention of HIV in adults: 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
Emtricitabine/Tenofovir disoproxil film-coated tablets 200/245 mg
Module 1.3.1 Page 2 of 28
components of Emtricitabine/Tenofovir disoproxil Hetero. Please refer
to the Summary of
Product Characteristics for these medicinal products.
If dose of Emtricitabine/Tenofovir disoproxil Hetero is missed w