Prezista 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Darunavir ethanolate

Available from:

Janssen-Cilag Ltd

ATC code:

J05AE10

INN (International Name):

Darunavir ethanolate

Dosage:

400mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5012674901854

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREZISTA 400 MG FILM-COATED TABLETS
darunavir
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What PREZISTA is and what it is used for
2.
What you need to know before you take PREZISTA
3.
How to take PREZISTA
4.
Possible side effects
5.
How to store PREZISTA
6.
Contents of the pack and other information
1.
WHAT PREZISTA IS AND WHAT IT IS USED FOR
WHAT IS PREZISTA?
PREZISTA contains the active substance darunavir. PREZISTA is an
antiretroviral medicine used in
the treatment of Human Immunodeficiency Virus (HIV) infection. It
belongs to a group of medicines
called protease inhibitors. PREZISTA works by reducing the amount of
HIV in your body. This will
improve your immune system and reduces the risk of developing
illnesses linked to HIV infection.
WHAT IT IS USED FOR?
The PREZISTA 400 milligram tablet is used to treat adults and children
(3 years of age and above, at
least 40 kilograms body weight) who are infected by HIV and
-
who have not used antiretroviral medicines before.
-
in certain patients who have used antiretroviral medicines before
(your doctor will determine
this).
PREZISTA must be taken in combination with a low dose of cobicistat or
ritonavir and other anti-HIV
medicines. Your doctor will discuss with you which combination of
medicines is best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREZISTA
DO NOT TAKE PREZISTA
-
if you are
ALLERGIC
to darunavir or any of the other ingredients of this medicine (listed
in section
6) or

Summary of Product characteristics

OBJECT 1
PREZISTA 400 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 26-Mar-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
PREZISTA 400 mg film-coated tablets
PREZISTA 800 mg film-coated tablets
2. Qualitative and quantitative composition
PREZISTA 400 mg film-coated tablets
Each film-coated tablet contains 400 mg of darunavir (as ethanolate).
Excipient with known effect: Each tablet contains 0.834 mg sunset
yellow FCF (E110).
PREZISTA 800 mg film-coated tablets
Each film-coated tablet contains 800 mg of darunavir (as ethanolate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
PREZISTA 400 mg film-coated tablets
Film-coated tablet.
Light orange oval shaped tablet of 19.1 mm, debossed with “400MG”
on one side and “TMC” on the
other side.
PREZISTA 800 mg film-coated tablets
Film-coated tablet.
Dark red oval shaped tablet of 20.0 mm, debossed with “800” on one
side and “T” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
PREZISTA, co-administered with low dose ritonavir is indicated in
combination with other antiretroviral
medicinal products for the treatment of patients with human
immunodeficiency virus (HIV-1) infection.
PREZISTA, co-administered with cobicistat is indicated in combination
with other antiretroviral
medicinal products for the treatment of human immunodeficiency virus
(HIV-1) infection in adult
patients (see section 4.2).
PREZISTA 400 mg and 800 mg tablets may be used to provide suitable
dose regimens for the treatment
of HIV-1 infection in adult and paediatric patients from the age of 3
years and at least 40 kg body weight
who are:
• antiretroviral therapy (ART)-naïve (see section 4.2).
• ART-experienced with no darunavir resistance associated mutations
(DRV-RAMs) and who have
plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells
x 10
6
/l. In deciding to initiate
treatment with PREZISTA in such ART-experienced patients, genotypic
testing should guide the use of
PREZISTA (see sections