TRUVADA tenofovir disoproxil fumarate / emtricitabine 300/200 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tenofovir disoproxil fumarate, Quantity: 300 mg; emtricitabine, Quantity: 200 mg

Available from:

Gilead Sciences Pty Ltd

INN (International Name):

Emtricitabine,Tenofovir disoproxil fumarate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: indigo carmine aluminium lake; magnesium stearate; croscarmellose sodium; titanium dioxide; triacetin; pregelatinised maize starch; microcrystalline cellulose; lactose monohydrate; hypromellose

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of HIV-1 infection,TRUVADA is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.,Pre-Exposure Prophylaxis TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples (see CLINICAL STUDIES).

Product summary:

Visual Identification: Blue, capsule shaped, film coated tablets debossed with "GILEAD" on one side of the tablet and "701" on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-09-22

Patient Information leaflet

TRUVADA Consumer Medicine Information v16.0 – (15 July 2020)
Page
1
of
6
TRUVADA
® TABLETS
_300_
_ _
_mg tenofovir disoproxil fumarate / 200 mg emtricitabine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read all of this leaflet carefully before
you start taking this medicine.
This leaflet answers some of the
common questions about TRUVADA
tablets. It does not contain all of the
available information.
It does not take the place of talking to
your doctor or pharmacist about your
medical condition or treatment. If you
have further questions, please ask your
doctor or your pharmacist.
Keep this leaflet with your TRUVADA
medicine. You may need to read it
again.
WHAT IS TRUVADA
_HOW TRUVADA WORKS _
TRUVADA consists of two medicines
combined in one tablet:
•
tenofovir disoproxil fumarate, also
called tenofovir DF
•
emtricitabine or FTC
These are
combined in one tablet to help
control Human Immunodeficiency Virus
(HIV) infection.
TRUVADA contains two active
ingredients that belong to a group of
antiviral medicines known as nucleoside
and nucleotide reverse transcriptase
inhibitors (NRTI).
_ _
_WHAT IS TRUVADA USED FOR _
•
to treat Human Immunodeficiency
Virus-1 (HIV-1) infection in adults
when taken in combination with
other anti-HIV medicines;
•
to help reduce the risk of getting
HIV infection when used with safer
sex practices in:
•
HIV-negative men who have
sex with men, who are at high
risk of getting infected with
HIV-1 through sex.
•
Male-female sex partners when
one partner has HIV-1 infection
and the other does not.
_WHEN TRUVADA IS USED TO _
_TREAT HIV INFECTION _
When used with other HIV-1 medicines
to treat HIV-1 infection, TRUVADA
may help:
•
Reduce the amount of HIV-1 in your
blood. This is called “viral load”.
•
Increase the number of CD4+ (T)
cells in your blood that help fight off
other infections.
Reducing the amount of HIV-1 and
increasing the CD4+ (T) cells in your
blood may help improve your immune
system.
This may reduce your risk of death or
infections that can happ

Summary of Product characteristics

AUSTRALIA
PRODUCT INFORMATION -
TRUVADA
® TENOFOVIR DISOPROXIL FUMARATE AND
EMTRICITABINE TABLETS
1
NAME OF THE MEDICINE
TRUVADA (tenofovir disoproxil fumarate/emtricitabine)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg tenofovir disoproxil fumarate
(tenofovir DF) which is
equivalent to 245 mg of tenofovir disoproxil and 200 mg emtricitabine.
Tenofovir DF is a white to off-white crystalline powder.
Emtricitabine is a white to off-white crystalline powder.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The tablets are blue, capsule-shaped, film-coated, debossed with
“GILEAD” on one side and with
“701” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF HIV-1 INFECTION
TRUVADA is indicated for the treatment of HIV infected adults over the
age of 18 years, in
combination with other antiretroviral agents.
PRE-EXPOSURE PROPHYLAXIS
TRUVADA is indicated in combination with safer sex practices for
pre-exposure prophylaxis
(PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high
risk. This indication is based
on clinical trials in men who have sex with men (MSM) at high risk for
HIV-1 infection and in
heterosexual serodiscordant couples (see section 5.1 Pharmacodynamic
properties, Clinical trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSE FOR TREATMENT OF HIV-1 INFECTION
ADULTS
: The recommended dose of TRUVADA is one tablet (containing 300 mg
tenofovir DF and
200 mg emtricitabine), taken orally, once daily. In order to optimise
the absorption of tenofovir, it
is recommended that TRUVADA should be taken with food.
RECOMMENDED DOSE FOR PRE-EXPOSURE PROPHYLAXIS
ADULTS:
The dose of TRUVADA in HIV-1 uninfected adults is one tablet
(containing 300 mg
tenofovir DF and 200 mg of emtricitabine), taken orally, once daily.
In order to optimise the
absorption of tenofovir, it is recommended that TRUVADA should be
taken with food.
CHILDREN_:_
The safety and efficacy of TRUVADA has not b