Emtricitabine/Tenofovir disoproxil Teva Tablet, film coated 200mg/245mg

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

EMTRICITABINE, TENOFOVIR DISOPROXIL

Disponível em:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

Código ATC:

J05AR03

DCI (Denominação Comum Internacional):

EMTRICITABINE 200 mg TENOFOVIR DISOPROXIL 245 mg

Forma farmacêutica:

FILM-COATED TABLET

Composição:

EMTRICITABINE 200 mg TENOFOVIR DISOPROXIL 245 mg

Tipo de prescrição:

POM

Área terapêutica:

ANTIVIRALS FOR SYSTEMIC USE

Status de autorização:

Withdrawn

Data de autorização:

2016-04-26

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE USER
EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA 200 MG/245 MG FILM-COATED
TABLETS
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 Teva is and what it is used
for
2.
What you need to know before you take Emtricitabine/Tenofovir
disoproxil Teva
3.
How to take Emtricitabine/Tenofovir disoproxil Teva
4.
Possible side effects
5.
How to store Emtricitabine/Tenofovir disoproxil Teva
6.
Contents of the pack and other information
1.
WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA IS AND WHAT IT IS USED
FOR
EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA 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 TEVA 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
longer effective or have caused
side effects.
o
Emtricitabine

Características técnicas

Page 1 of 36
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 36
1.
NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg film-coated
tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of
tenofovir disoproxil
(equivalent to 291.22 mg of tenofovir disoproxil phosphate or 136 mg
of tenofovir).
For the full list of excipients, see section 6.1.
_Sodium _
This medicinal product contains less than 1 mmol sodium (23 mg) per
tablet, i.e. essentially
‘sodium- free’.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Green to light green, oval shaped film coated tablets, of approximate
dimensions 18mm x 10mm,
debossed with “E T” on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of HIV-1 infection:_
Emtricitabine/Tenofovir disoproxil Teva is indicated in antiretroviral
combination therapy for the
treatment of HIV-1 infected adults (see section 5.1).
Emtricitabine/Tenofovir disoproxil Teva 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 Teva 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 Teva should be initiated by a
physician experienced in the
management of HIVinfection.
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:_
One tablet, once daily.
Page 3 of 36
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
Em