Evotaz 300mg150mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Atazanavir sulfate; Cobicistat

Disponible desde:

Bristol-Myers Squibb Pharmaceuticals Ltd

Código ATC:

J05AR15

Designación común internacional (DCI):

Atazanavir sulfate; Cobicistat

Dosis:

300mg ; 150mg

formulario farmacéutico:

Tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05030100; GTIN: 5012712043492

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOTAZ 300 MG/150 MG FILM-COATED TABLETS
atazanavir/cobicistat
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 EVOTAZ is and what it is used for
2.
What you need to know before you take EVOTAZ
3.
How to take EVOTAZ
4.
Possible side effects
5.
How to store EVOTAZ
6.
Contents of the pack and other information
1.
WHAT EVOTAZ IS AND WHAT IT IS USED FOR
EVOTAZ contains two active substances:

ATAZANAVIR, AN ANTIVIRAL (OR ANTIRETROVIRAL) MEDICINE.
It is one of a group called
_protease _
_inhibitors_
. These medicines control human immunodeficiency virus (HIV) infection
by stopping
production of a protein that HIV needs for its multiplication. They
work by reducing the amount
of HIV in your body and this in turn, strengthens your immune system.
In this way atazanavir
reduces the risk of developing illnesses linked to HIV infection.

COBICISTAT, A BOOSTER (PHARMACOKINETIC ENHANCER) TO HELP IMPROVE THE
EFFECTS OF ATAZANAVIR
.
Cobicistat, does not directly treat your HIV, but boosts the levels of
atazanavir in the blood. It
does this by slowing down the breakdown of atazanavir which will make
it stay in the body for
longer.
EVOTAZ may be used by adults aged 18 years of age and older who are
infected with HIV, the virus
that

Ficha técnica

OBJECT 1
EVOTAZ 300 MG/150 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 15-May-2018 | Bristol-Myers
Squibb Pharmaceuticals
limited
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
EVOTAZ 300 mg/150 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains atazanavir sulphate corresponding to
300 mg atazanavir and 150 mg of
cobicistat.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Pink, oval, biconvex, film-coated tablet of approximate dimensions of
19 mm x 10.4 mm, debossed with
"3641" on one side and plain on the other side.
4. Clinical particulars
4.1 Therapeutic indications
EVOTAZ is indicated in combination with other antiretroviral medicinal
products for the treatment of
HIV-1 infected adults without known mutations associated with
resistance to atazanavir (see sections 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_
The recommended dose of EVOTAZ is one tablet once daily taken orally
with food (see section 5.2).
_Advice on missed doses_
If EVOTAZ is missed within 12 hours of the time it is usually taken,
patients should be instructed to take
the prescribed dose of EVOTAZ with food as soon as possible. If this
is noticed later than 12 hours of the
time it is usually taken, the missed dose should not be taken and the
patient should resume the usual
dosing schedule.
Special populations
_Renal impairment_
Based on the very limited renal elimination of cobicistat and
atazanavir, no special precautions or dose
adjustments of EVOTAZ are required for patients with renal impairment.
EVOTAZ is not recommended for patients undergoing haemodialysis (see
sections