TENOFOVIR ARX tenofovir disoproxil fumarate 300 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tenofovir disoproxil fumarate, Quantity: 300 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Tenofovir disoproxil fumarate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: hyprolose; hypromellose; indigo carmine aluminium lake; lactose; colloidal anhydrous silica; calcium stearate; titanium dioxide; crospovidone; macrogol 8000

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tenofovir disoproxil fumarate in combination with other antiretroviral agents is indicated for the treatment of HIV-infected adults and paediatric patients 12 years of age and older.,Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in adults (see CLINICAL TRIALS).,Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels or evidence of active inflammation.

Product summary:

Visual Identification: Light blue, almond shaped, biconvex, coated tablet. Engraved 'TEN' over '300' on one side, 'APO' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-04-29

Patient Information leaflet

TENOFOVIR ARX
1
TENOFOVIR ARX
_Tenofovir disoproxil fumarate _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about tenofovir. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Tenofovir belongs to a group of
medicines called nucleoside analog
reverse transcriptase inhibitors
(NRTIs).
CHRONIC HEPATITIS B (CHB)
Tenofovir is an antiviral medication
used to treat CHB in adults and
children aged over 12 years and
weighing at least 35 kg.
Tenofovir works by interfering with
the normal working of enzymes that
are essential for HBV to reproduce
itself. This may help lower the
amount of hepatitis B virus in your
body by lowering the ability of the
virus to multiply and infect new liver
cells. It can improve the
inflammation and scar tissue caused
by the hepatitis B virus in your liver.
Lowering the amount of virus in your
body may reduce the chance of
developing cirrhosis, liver failure and
liver cancer.
We do not know how long this
medicine may help treat your
hepatitis. Sometimes viruses change
in your body and medicines no
longer work. This is called drug
resistance.
HUMAN IMMUNODEFICIENCY VIRUS
(HIV-1) INFECTION
Tenofovir is also used to treat HIV-1
infection in adults and children aged
over 12 years and weighing at least
35 kg. It is always used in
combination with other anti-HIV-1
medicines to treat people with HIV-1
infection.
HIV-1 infection destroys CD4 (T)
cells, which are important to the
immune system. After many T cells
are destroyed, acquired immune
deficiency syndrome (AIDS)
develops.
This medicine hel

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
TENOFOVIR APOTEX (TENOFOVIR DISOPROXIL
FUMARATE) TABLETS
1
NAME OF THE MEDICINE
Tenofovir disoproxil fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg tenofovir disoproxil fumarate as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Light blue, almond shaped, biconvex, coated tablet. Engraved “TEN”
over “300” on one side,
“APO” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tenofovir disoproxil fumarate in combination with other antiretroviral
agents is indicated for the
treatment of HIV-infected adults and paediatric patients 12 years of
age and older.
Tenofovir disoproxil fumarate is indicated for the treatment of
chronic hepatitis B in adults (see
section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS).
Tenofovir disoproxil fumarate is indicated for the treatment of
chronic hepatitis B in paediatric
patients 12 years of age and older with compensated liver disease and
with evidence of
immune active disease, i.e. active viral replication, persistently
elevated serum ALT levels or
evidence of active inflammation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Tenofovir APOTEX tablets are intended for oral administration.
DOSAGE
ADULTS
The recommended dose is 300 mg (one tablet) once daily taken orally.
In order to optimize the
absorption of tenofovir, it is recommended that the tablet be taken
with food.
PAEDIATRIC PATIENTS (≥ 12 YEARS OF AGE AND ≥ 35 KG)
The recommended dose for paediatric patients (12 years of age and
older), who weigh ≥ 35
kg, is 300 mg (one tablet) once daily taken orally. In order to
optimize the absorption of
tenofovir, it is recommended that the tablet be taken with food.
2
The safety and efficacy of tenofovir disoproxil fumarate in patients
under the age of 12 years
have not been established. Tenofovir disoproxil fumarate must not be
administered to children
under 12, until further data become