Eviplera
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
13-12-2022
Produktets egenskaber
(SPC)
13-12-2022
Offentlige vurderingsrapport
(PAR)
26-07-2016
Aktiv bestanddel:
emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate
Tilgængelig fra:
Gilead Sciences International Ltd
ATC-kode:
J05AR08
INN (International Name):
emtricitabine, rilpivirine, tenofovir disoproxil
Terapeutisk gruppe:
Antivirals for systemic use
Terapeutisk område:
HIV Infections
Terapeutiske indikationer:
Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000 HIV-1 RNA copies/mL. As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of Eviplera.
Produkt oversigt:
Revision: 25
Autorisation status:
Authorised
Autorisation dato:
2011-11-27
Indlægsseddel
45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVIPLERA 200 MG/25 MG/245 MG FILM-COATED TABLETS
emtricitabine/rilpivirine/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 Eviplera is and what it is used for
2.
What you need to know before you take Eviplera
3.
How to take Eviplera
4.
Possible side effects
5.
How to store Eviplera
6.
Contents of the pack and other information
1.
WHAT EVIPLERA IS AND WHAT IT IS USED FOR
EVIPLERA CONTAINS THREE ACTIVE SUBSTANCES
that are used to treat Human Immunodeficiency Virus
(HIV) infection:
•
Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI).
•
Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI).
•
Tenofovir disoproxil, a nucleotide reverse transcriptase inhibitor
(NtRTI).
Each of these active substances, also known as antiretroviral
medicines, works by interfering with an
enzyme (a protein called ‘reverse transcriptase’) that is
essential for the virus to multiply.
Eviplera reduces the amount of HIV in your body. This, will improve
your immune system and
reduces the risk of developing illnesses linked to HIV infection.
EVIPLERA IS A TREATMENT FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV)
infection in adults aged
18 years and over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVIPLERA
DO NOT TAKE EVIPLERA
•
IF YOU ARE ALLERGIC
to emtricitabine, rilpivirine, tenofovir disoproxil, or any of the
other
ingredients of this medicine (listed in section 6 of this leaflet).
IF THIS APPLIES
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Eviplera 200 mg/25 mg/245 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of
rilpivirine (as hydrochloride) and
245 mg of tenofovir disoproxil (as fumarate).
Excipients with known effect
Each film-coated tablet contains 277 mg lactose monohydrate and 4
micrograms sunset yellow
aluminium lake (E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Purplish-pink, capsule-shaped, film-coated tablet of dimensions 19 mm
x 8.5 mm, debossed on one
side with “GSI” and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eviplera is indicated for the treatment of adults infected with human
immunodeficiency virus type 1
(HIV-1) without known mutations associated with resistance to the
non-nucleoside reverse
transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and
with a viral load ≤ 100,000
HIV-1 RNA copies/mL (see sections 4.2, 4.4 and 5.1).
Genotypic resistance testing and/or historical resistance data should
guide the use of Eviplera (see
sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Eviplera should be initiated by a physician experienced in the
management of HIV infection.
Posology
_Adults _
The recommended dose of Eviplera is one tablet, taken orally, once
daily. Eviplera
MUST BE TAKEN
WITH FOOD
(see section 5.2).
Where discontinuation of therapy with one of the components of
Eviplera is indicated or where dose
modification is necessary, separate preparations of emtricitabine,
rilpivirine hydrochloride and
tenofovir disoproxil are available. Please refer to the Summary of
Product Characteristics for these
medicinal products.
If a patient misses a dose of Eviplera within 12 hours of the time it
is usually taken, the patient should
take Eviplera with food as soon as possible and resume the normal
dosing schedule. If a patient
misses a dose of Eviplera by
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