Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

efavirenz, emtricitabine, tenofovir disoproxil succinate

Available from:

KRKA, d.d., Novo mesto

ATC code:

J05AR06

INN (International Name):

efavirenz, emtricitabine, tenofovir disoproxil

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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 Krka prior to initiation of their first antiretroviral treatment regimen.The demonstration of the benefit 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 efavirenz/emtricitabine/tenofovir disoproxil.No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

Product summary:

Revision: 10

Authorization status:

Authorised

Authorization date:

2018-02-08

Patient Information leaflet

52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA 600 MG/200 MG/245 MG
FILM-COATED TABLETS
efavirenz/emtricitabine/tenofovir disoproxil
(efavirenzum/emtricitabinum/tenofovirum disoproxilum)
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 Krka is and what it
is used for
2.
What you need to know before you take
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
3.
How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
4.
Possible side effects
5.
How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
6.
Contents of the pack and other information
1.
WHAT EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA IS AND WHAT IT
IS USED FOR
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA 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 KRKA 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 a

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 600 mg/200 mg/245 mg
film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of efavirenz (efavirenzum),
200 mg of emtricitabine
(emtricitabinum) and 245 mg of tenofovir disoproxil (tenofovirum
disoproxilum) (as
succinate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Tablets are light orange pink, oval, biconvex, film-coated tablets
with beveled edges. Tablet
dimension: 20 x 11 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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 Krka prior to
initiation of their first antiretroviral treatment regimen (see
sections 4.4 and 5.1).
The demonstration of the benefit 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
efavirenz/emtricitabine/tenofovir disoproxil (see section
5.1). No data are currently available from clinical studies with
efavirenz/emtricitabine/tenofovir
disoproxil in treatment-naïve or in heavily pretreated patients.
No data are available to support the combination of
efavirenz/emtricitabine/tenofovir disoproxil and
other antiretroviral agents.