Odefsey 200mg25mg25mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Tenofovir alafenamide fumarate; Rilpivirine hydrochloride; Emtricitabine

Disponible des:

Gilead Sciences International Ltd

Designació comuna internacional (DCI):

Tenofovir alafenamide fumarate; Rilpivirine hydrochloride; Emtricitabine

Dosis:

25mg ; 25mg ; 200mg

formulario farmacéutico:

Tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Never Valid To Prescribe As A VMP

Resumen del producto:

BNF: 05030100

Informació per a l'usuari

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ODEFSEY 200 MG/25 MG/25 MG FILM-COATED TABLETS
emtricitabine/rilpivirine/tenofovir alafenamide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Odefsey is and what it is used for
2.
What you need to know before you take Odefsey
3.
How to take Odefsey
4.
Possible side effects
5.
How to store Odefsey
6.
Contents of the pack and other information
1.
WHAT ODEFSEY IS AND WHAT IT IS USED FOR
Odefsey is an antiviral medicine used to treat infection by the HUMAN
IMMUNODEFICIENCY
VIRUS (HIV). It is a single tablet that contains a combination of
three active substances:
EMTRICITABINE, RILPIVIRINE and TENOFOVIR ALAFENAMIDE. Each of these
active substances works by
interfering with an enzyme called ‘reverse transcriptase’, which
is essential for the HIV-1 virus to
multiply.
Odefsey reduces the amount of HIV in your body. This will improve your
immune system and reduce
the risk of developing illnesses linked to HIV infection.
Odefsey is used in adults and adolescents aged 12 years and older, who
weigh at least 35 kg.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ODEFSEY
DO NOT TAKE ODEFSEY:

IF YOU ARE ALLERGIC TO EMTRICITABINE, RILPIVIRINE, TENOFOVIR
ALAFENAMIDE or any of the other
ingredients of this medicine (listed

Fitxa tècnica

OBJECT 1
ODEFSEY 200 MG/25 MG/25 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 30-May-2018 | Gilead
Sciences Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Odefsey 200 mg/25 mg/25 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 200 mg of emtricitabine, rilpivirine
hydrochloride equivalent to 25 mg of
rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of
tenofovir alafenamide.
Excipients with known effect
Each tablet contains 189.8 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Grey, capsule-shaped, film-coated tablets, of dimensions 15 mm x 7 mm,
debossed with “GSI” on one
side of the tablet and “255” on the other side of the tablet.
4. Clinical particulars
4.1 Therapeutic indications
Odefsey is indicated for the treatment of adults and adolescents (aged
12 years and older with body
weight at least 35 kg) infected with human immunodeficiency virus-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).
4.2 Posology and method of administration
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_Adults and adolescents aged 12 years and older, weighing at least 35
kg_
One tablet to be taken once daily with food (see section 5.2).
If the patient misses a dose of Odefsey within 12 hours of the time it
is usually taken, the patient should
take Odefsey with food as soon as possible and resume the normal
dosing schedule. If a patient misses a
dose of Odefsey by more than 12 hours, the