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

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Emtricitabine; Tenofovir disoproxil

Tilgængelig fra:

Accord Healthcare Ireland Ltd.

ATC-kode:

J05AR; J05AR03

INN (International Name):

Emtricitabine; Tenofovir disoproxil

Dosering:

200 mg/245 milligram(s)

Lægemiddelform:

Film-coated tablet

Terapeutisk område:

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

Autorisation status:

Not marketed

Autorisation dato:

2017-05-05

Indlægsseddel

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

Produktets egenskaber

Health Products Regulatory Authority
06 April 2020
CRN009KSH
Page 1 of 30
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovir disoproxil 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 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 tablets is indicated in
antiretroviral combination therapy for the treatment of HIV-1 infected
adults(see section 5.1).
Emtricitabine/Tenofovir disoproxil tablets 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 tablets 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 tablets 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 discontinu