TENOFOVIR / EMTRICITABINE SANDOZ 301/200 tenofovir disoproxil succinate / emtricitabine 301/200 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

emtricitabine, Quantity: 200 mg; tenofovir disoproxil succinate, Quantity: 300.6 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 3350; indigo carmine aluminium lake; magnesium stearate; isopropyl alcohol; polyvinyl alcohol; microcrystalline cellulose; titanium dioxide; lactose monohydrate; purified talc; croscarmellose sodium; purified water; pregelatinised maize starch

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of HIV-1 infection,TENOFOVIR/EMTRICITABINE SANDOZ is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.,Pre-Exposure Prophylaxis,TENOFOVIR/EMTRICITABINE SANDOZ 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).

Product summary:

Visual Identification: Blue coloured, capsule shaped film-coated tablets, plain on both sides.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-03-01

Patient Information leaflet

Tenofovir/Emtricitabine Sandoz® 301/200
1
TENOFOVIR/EMTRICITABINE SANDOZ® 301/200
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TENOFOVIR/EMTRICITABINE SANDOZ 301/200?
Tenofovir/Emtricitabine Sandoz 301/200 contains the active ingredients
tenofovir disoproxil succinate and emtricitabine.
Tenofovir/Emtricitabine Sandoz 301/200 is used to help control Human
Immunodeficiency Virus (HIV) infection.
For more information, see Section 1. Why am I using
Tenofovir/Emtricitabine Sandoz 301/200?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TENOFOVIR/EMTRICITABINE SANDOZ
301/200?
Do not use if you have ever had an allergic reaction to tenofovir
disoproxil succinate/emtricitabine or any of the ingredients
listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Tenofovir/Emtricitabine Sandoz 301/200?
in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Tenofovir/Emtricitabine Sandoz
301/200 and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE TENOFOVIR/EMTRICITABINE SANDOZ 301/200?
•
Take one Tenofovir/Emtricitabine Sandoz 301/200 tablet once daily or
as advised by your doctor at the same time each
day.
More instructions can be found in Section 4. How do I use
Tenofovir/Emtricitabine Sandoz 301/200? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TENOFOVIR/EMTRICITABINE SANDOZ 301/200?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Tenofovir/Emtricitabine Sandoz
301/200.
•
Do not miss any doses of Tenofovir/Emtricitabine Sandoz 301/200.
•
Tell your doctor if you become pregnant while taking this medicine.

Summary of Product characteristics

210301-tenofovir-emtricitabine-sandoz-301/200-pi
Page 1 of 41
AUSTRALIAN PRODUCT INFORMATION
TENOFOVIR/EMTRICITABINE SANDOZ
® 301/200
TENOFOVIR DISOPROXIL SUCCINATE / EMTRICITABINE 300.6 MG / 200 MG
TABLETS
1.
NAME OF THE MEDICINE
Tenofovir disoproxil succinate / emtricitabine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300.6 mg tenofovir disoproxil
succinate which is equivalent to 245 mg
of tenofovir disoproxil and 200 mg emtricitabine.
Tenofovir disoproxil succinate is a white to off-white crystalline
powder. Emtricitabine is a white to off-
white crystalline powder.
Excipients with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
The tablets are blue, capsule-shaped, film-coated and plain on both
sides.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC
INDICATIONS
TREATMENT OF HIV-1 INFECTION
TENOFOVIR/EMTRICITABINE SANDOZ 301/200 is indicated for the treatment
of HIV infected
adults over the age of 18 years, in combination with other
antiretroviral agents.
PRE-EXPOSURE PROPHYLAXIS
TENOFOVIR/EMTRICITABINE SANDOZ 301/200 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 TENOFOVIR/EMTRICITABINE SANDOZ 301/200 is
one tablet
(containing 300.6 mg tenofovir disoproxil succinate and 200 mg
emtricitabine), taken orally, once daily.
In
order
to
optimise
the
absorption
of
tenofovir,
it
is
recommended
that
TENOFOVIR/EMTRICITABINE SANDOZ 301/200 should be taken with food.
RECOMMENDED DOSE FOR PRE-EXPOSURE PROPHYLAXIS
ADULTS
: The dose of TENOFOVIR/EMTRICITABINE SANDOZ 301/200 in