Emtricitabine/Tenofovir disoproxil Rowex 200 mg/245 mg film-coated tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Emtricitabine; Tenofovir disoproxil

Disponível em:

Rowex Ltd

Código ATC:

J05AR; J05AR03

DCI (Denominação Comum Internacional):

Emtricitabine; Tenofovir disoproxil

Dosagem:

200 mg/245 milligram(s)

Forma farmacêutica:

Film-coated tablet

Tipo de prescrição:

Product subject to prescription which may not be renewed (A)

Área terapêutica:

Antivirals for treatment of HIV infections, combinations; tenofovir disoproxil and emtricitabine

Status de autorização:

Marketed

Data de autorização:

2017-05-12

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
EMTRICITABINE/TENOFOVIR DISOPROXIL ROWEX 200MG/245MG 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 Rowex is and what it is used
for
2.
What you need to know before you take Emtricitabine/Tenofovir
disoproxil Rowex
3.
How to take Emtricitabine/Tenofovir disoproxil Rowex
4.
Possible side effects
5.
How to store Emtricitabine/Tenofovir disoproxil Rowex
6.
Contents of the pack and other information
1.
WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL ROWEX IS AND WHAT IT IS USED
FOR
EMTRICITABINE/TENOFOVIR DISOPROXIL ROWEX 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 ROWEX 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.
•
Emtricitabine/Tenofovi

Características técnicas

Health Products Regulatory Authority
24 February 2021
CRN009RD7
Page 1 of 29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovir disoproxil Rowex 200 mg/245 mg film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg emtricitabine and 245 mg
tenofovir disoproxil.
Excipient(s) with known effect
Each tablet contains 216 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue, capsule shaped, film coated tablet, with dimensions of
approximately 19 mm x 9 mm, 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 Rowex is indicated in
antiretroviral combination therapy for the treatment of HIV-1 infected
adults (see section 5.1).
Emtricitabine/Tenofovir disoproxil Rowex 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 Rowex 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 Rowex 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/Tenof