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

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Emtricitabine; Tenofovir disoproxil

Dostupné z:

Accord Healthcare Ireland Ltd.

ATC kód:

J05AR; J05AR03

INN (Medzinárodný Name):

Emtricitabine; Tenofovir disoproxil

Dávkovanie:

200 mg/245 milligram(s)

Forma lieku:

Film-coated tablet

Terapeutické oblasti:

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

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2019-06-28

Príbalový leták

1
NL/H/4213/001/IB/012, version 03, March 2024
PACKAGE LEAFLET: INFORMATION FOR THE USER
EMTRICITABINE/TENOFOVIR DISOPROXIL ACCORDPHARMA 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 Accordpharma is and what it is
used for
2.
What you need to know before you take Emtricitabine/Tenofovir
disoproxil Accordpharma
3.
How to take Emtricitabine/Tenofovir disoproxil Accordpharma
4.
Possible side effects
5.
How to store Emtricitabine/Tenofovir disoproxil Accordpharma
6.
Contents of the pack and other information
1.
WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL ACCORDPHARMA IS AND WHAT IT IS
USED FOR
EMTRICITABINE/TENOFOVIR DISOPROXIL ACCORDPHARMA 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 ACCORDPHARMA 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 oth

Súhrn charakteristických

Health Products Regulatory Authority
20 March 2024
CRN00DV61
Page 1 of 30
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emtricitabine/Tenofovir disoproxil Accordpharma 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 300 mg of tenofovir
disoproxil fumarate or 136 mg of tenofovir).
Excipient(s) with known effect: Each tablet contains 162 mg lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue, capsule shaped, of approx. 19x9 mm film-coated tablets de-bossed
with 'H' on one side and 'E44' on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Treatment of HIV-1 infection:_
Emtricitabine/Tenofovir disoproxil Accordpharma is indicated in
antiretroviral combination therapy for the treatment of HIV-1
infected adults (see section 5.1).
Emtricitabine/Tenofovir disoproxil Accordpharma 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 Accordpharma 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 Accordpharma should be initiated by
a physician experienced in the management of HIV
infection.
Posology
_Treatmentof HIV inadults 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
necessar