Efavirenz/ Emtricitabine/ Tenofovir disoproxil DEXTREG Tablet, film coated 600mg/200mg/245mg,

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL

Available from:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

ATC code:

J05AR06

INN (International Name):

EFAVIRENZ 600 mg EMTRICITABINE 200 mg TENOFOVIR DISOPROXIL 245 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

EFAVIRENZ 600 mg EMTRICITABINE 200 mg TENOFOVIR DISOPROXIL 245 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2017-11-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ/ EMTRICITABINE/ TENOFOVIR DISOPROXIL PHAROS 600 MG/200
MG/245 MG FILM-COATED TABLETS
Efavirenz/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 Efavirenz/ Emtricitabine/ Tenofovir disoproxil PharOS is and what
it is used for
2.
What you need to know before you take Efavirenz/ Emtricitabine/
Tenofovir disoproxil PharOS
3.
How to take Efavirenz/ Emtricitabine/ Tenofovir disoproxil PharOS
4.
Possible side effects
5.
How to store Efavirenz/ Emtricitabine/ Tenofovir disoproxil PharOS
6.
Contents of the pack and other information
1.
WHAT EFAVIRENZ/ EMTRICITABINE/ TENOFOVIR DISOPROXIL PHAROS IS AND WHAT
IT IS USED FOR
EFAVIRENZ/ EMTRICITABINE/ TENOFOVIR DISOPROXIL PHAROS CONTAINS THREE
ACTIVE SUBSTANCES
that are
used to treat human immunodeficiency virus (HIV) infection:
-
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
-
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
-
Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI)
Each of these active substances, also known as antiretroviral
medicines, work by interfering with an
enzyme (reverse transcriptase) that is essential for the virus to
multiply.
EFAVIRENZ/ EMTRICITABINE/ TENOFOVIR DISOPROXIL PHAROS IS A TREATMENT
FOR HUMAN
IMMUNODEFICIENCY VIRUS
(HIV) infection in adults aged 18 years and over who have previously
been
treated with other antiretroviral medicines and have their HIV-1
infection under control fo

Summary of Product characteristics

Page 1 of 56
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Efavirenz/ Emtricitabine/ Tenofovir disoproxil PharOS 600 mg/200
mg/245 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of efavirenz, 200 mg of
emtricitabine and tenofovir
disoproxil succinate equivalent to 245 mg of tenofovir disoproxil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, capsule-shaped film-coated tablets, plain on both sides, with
dimensions 11 mm x 22 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Efavirenz/ Emtricitabine/ Tenofovir disoproxil PharOS is a fixed-dose
combination of
efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for
the treatment of human
immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and
over with virologic
suppression to HIV-1 RNA levels of < 50 copies/ml on their current
combination antiretroviral
therapy for more than three months. Patients must not have experienced
virological failure on
any prior antiretroviral therapy and must be known not to have
harboured virus strains with
mutations conferring significant resistance to any of the three
components contained in
Efavirenz/ Emtricitabine/ Tenofovir disoproxil PharOS prior to
initiation of their first
antiretroviral treatment regimen (see sections 4.4 and 5.1).
The demonstration of the benefit of the fixed-dose combination of
efavirenz/emtricitabine/tenofovir disoproxil is primarily based on
48-week data from a clinical
study in which patients with stable virologic suppression on a
combination antiretroviral
therapy changed to the fixed-dose combination of
efavirenz/emtricitabine/tenofovir disoproxil
(see section 5.1). No data are currently available from clinical
studies with the fixed-dose
combination of efavirenz/emtricitabine/tenofovir disoproxil in
treatment-naïve or in heavily
pretreated patients.
No data are available to support the combination of efavirenz,
emtricitabine and tenofov