Eviplera 200mg25mg245mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Emtricitabine; Rilpivirine hydrochloride; Tenofovir disoproxil fumarate

Fáanlegur frá:

Gilead Sciences International Ltd

INN (Alþjóðlegt nafn):

Emtricitabine; Rilpivirine hydrochloride; Tenofovir disoproxil fumarate

Skammtar:

200mg ; 25mg ; 245mg

Lyfjaform:

Tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Never Valid To Prescribe As A VMP

Vörulýsing:

BNF: 05030100; GTIN: 5391507140432

Upplýsingar fylgiseðill

1
B. PACKAGE LEAFLET
2
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 of the 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 APP

Vara einkenni

OBJECT 1
EVIPLERA 200 MG/25 MG/245 MG FILM COATED
TABLETS
Summary of Product Characteristics Updated 01-Jun-2018 | Gilead
Sciences Ltd
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 fumarate 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 s