FENOFIBRATE SANDOZ fenofibrate 145 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fenofibrate, Quantity: 145 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Fenofibrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium lauryl sulfate; lactose monohydrate; hypromellose; magnesium stearate; croscarmellose sodium; sucrose; microcrystalline cellulose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Fenofibrate Sandoz 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. Fenofibrate Sandoz is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. Fenofibrate Sandoz does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy.

Product summary:

Visual Identification: White to off white oval, biconvex film coated tablets, debossed with J on one side and 136 on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-08-31

Patient Information leaflet

FENOFIBRATE SANDOZ
®
1
FENOFIBRATE SANDOZ
®
_fenofibrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fenofibrate Sandoz.
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
SANDOZ IS USED FOR
Fenofibrate Sandoz is used to help
regulate cholesterol and triglycerides
which are fat-like substances in the
blood.
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.
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 patients, Fenofibrate Sandoz
reduces the bad cholesterol and can
actually raise the good cholesterol.
Patients
with
type
2
diabetes
may
have
some
level
of
diabetic
retinopathy,
a
complication
of
diabetes that may lead to vision loss
or
impairment.

Summary of Product characteristics

191205-fenofibrate-sandoz-pi
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
FENOFIBRATE SANDOZ
® (FENOFIBRATE) FILM-COATED TABLET
1.
NAME OF THE MEDICINE
Fenofibrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fenofibrate Sandoz 145 mg tablets contain 145 mg of fenofibrate
nanoparticles.
_Excipients with known effect:_
lactose monohydrate, sucrose, soya lecithin.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Fenofibrate Sandoz 145 mg tablets are
white to off white, oval, biconvex film coated tablets,
debossed with J on one side and 136 on the other side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Fenofibrate Sandoz 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.
Fenofibrate Sandoz is indicated for the reduction in the progression
of diabetic retinopathy in
patients with type 2 diabetes and existing diabetic retinopathy.
Fenofibrate Sandoz does not
replace the appropriate control of blood pressure, blood glucose and
blood lipids in reducing
the progression of diabetic retinopathy.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
#
Fenofibrate 48 mg is unavailable in this brand however is available in
other brands.
DOSAGE
_ADULTS (DYSLIPIDAEMIA AND DIABETIC RETINOPATHY) _
Fenofibrate Sandoz is presented as a 145 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
Section 4.2 Dose and
method of administration – Renal impairment).
Patients should never be administered any combination of the 145 mg
tablet of fenofibrate.
There is no indication for use of fenofibrate dosages above 145 mg per
day. Fenofibrate 145
mg should be swallowed whole with a glass of water. Fenofibrate 145 mg
may be given at any
time of the day, with or without food, but it is recommended that they
be taken at the sa