FENOFIBRATE RBX fenofibrate 48mg film coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fenofibrate, Quantity: 48 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Fenofibrate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: sucrose; pregelatinised maize starch; silicon dioxide; sodium lauryl sulfate; sodium stearylfumarate; hypromellose; crospovidone; microcrystalline cellulose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Fenofibrate is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types II, III, IV and V dyslipidaemia; - dyslipidaemia associated with type 2 diabetes.

Product summary:

Visual Identification: White to off-white, oval shaped, biconvex film coated tablets debossed with 'RH 37' on one side and other side plain.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-02-29

Patient Information leaflet

FENOFIBRATE RBX v3.0
1
FENOFIBRATE RBX
®
_fenofibrate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Fenofibrate RBX.
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 or pharmacist
has weighed the risks of you taking
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 need to read it again.
WHAT FENOFIBRATE RBX
IS USED FOR
Fenofibrate RBX is used to help
regulate
cholesterol
and
triglycerides
which
are
fat-like
substances in the blood.
Everyone has cholesterol in their
blood.
It
is
a
type
of
blood
fat
needed
by
the
body
for
many
things, such as making bile acids
(which help digest food) and some
hormones.
Cholesterol
is
present
in
many
foods and is also made in your
body by the liver. If your body does
not
balance
the
amount
of
cholesterol
it
needs
with
the
amount of cholesterol eaten, then
your cholesterol becomes too high.
High cholesterol is more likely to
occur with certain diseases or if
you have a family history of high
cholesterol.
When
you
have
high
levels
of
cholesterol
it
may
'stick'
to
the
inside
of
your
blood
vessels
instead
of
being
carried
to
the
parts
of
the
body
where
it
is
needed.
Having
high
levels
of
‘bad’
cholesterol
and
triglycerides
can
be a problem. Over time, this can
form hard areas (called plaque) on
the
walls of
your blood
vessels,
making
it
more
difficult
for
the
blood to flow. This blocking of your
blood
vessels
can
lead
to
heart
disease (such as heart attack and
angina), and stroke.
Cholesterol is carried through the
body by different proteins, LDL and
HDL. LDL cholesterol is the 'bad'
cholesterol
that
can
block
your
blood vessels. HDL cholesterol is
the
'good'
cholesterol
that
is
thought
to
remove
the
'bad'
cholesterol from the blood vessels.
In most pat

Summary of Product characteristics

FENOFIBRATE RBX PI Version 4
1
AUSTRALIAN PRODUCT INFORMATION FENOFIBRATE RBX
(FENOFIBRATE) 48MG AND 145MG TABLETS
1 NAME OF THE MEDICINE
Fenofibrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
FENOFIBRATE RBX tablets contain 48 mg or 145 mg of fenofibrate
nanoparticles.
Excipients with known effect: Sugars as sucrose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Tablet.
FENOFIBRATE RBX 48mg tablet: white to off-white, oval shaped, biconvex
film coated tablets
debossed with ‘RH 37’ on one side and plain on the other side.
FENOFIBRATE RBX 145mg tablet: White to off-white, oval shaped,
biconvex film coated tablets
debossed with ‘RH 38’ on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fenofibrate is indicated as an adjunct to diet in the treatment of:

hypercholesterolaemia;

types II, III, IV and V dyslipidaemia;

dyslipidaemia associated with type 2 diabetes.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS (DYSLIPIDAEMIA)
FENOFIBRATE RBX is presented as a 145 mg tablet and a 48 mg tablet.
The usual dose of fenofibrate
is 1 x 145 mg tablet. Although 3 x 48 mg tablets are equivalent to 1 x
145 mg tablet, the 48 mg tablets
are only recommended when a decreased dosage is required (see RENAL
IMPAIRMENT).
FENOFIBRATE RBX PI Version 4
2
Patients should never be administered any combination of the 48 mg
tablet and the 145 mg tablet of
fenofibrate. There is no indication for use of fenofibrate dosages
above 145 mg per day.
FENOFIBRATE RBX 145 mg and 48 mg tablets should be swallowed whole
with a glass of water.
FENOFIBRATE RBX 145 mg and 48 mg may be given at any time of the day,
with or without food, but
it is recommended that they be taken at the same time each day.
Dietary measures instituted before
therapy should be continued.
ELDERLY
In elderly patients without renal impairment, the normal adult dose is
recommended.
RENAL IMPAIRMENT
In renal dysfunction, the dosage may need to be reduced depending on
the rate of creat