APO-FENOFIBRATE fenofibrate 145 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fenofibrate, Quantity: 145 mg

Available from:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose; sodium lauryl sulfate; hypromellose; croscarmellose sodium; magnesium stearate; purified water; xanthan gum; PEG-40 stearate; benzoic acid; glyceryl monostearate; methylcellulose; polysorbate 65; simethicone; sorbic acid; sulfuric acid

Administration route:

Oral

Units in package:

30

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: Fenofibrate 145 mg tablets are white to off-white biconvex oblong tablets, ca 15.5 x 8.5 mm debossed with "F" on one side and "145" on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-05-17

Patient Information leaflet

APO-FENOFIBRATE
1
APO-FENOFIBRATE
_fenofibrate _
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 this medicine. 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 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 THIS MEDICINE IS
USED FOR
APO-Fenofibrate contains the active
ingredient fenofibrate.
Fenofibrate is used to help regulate
cholesterol and triglycerides which
are fat-like substances in the blood.
Fenofibrate belongs to a group of
medicines known as fibric acid
derivatives. It works through the
activation of a cell nuclear receptor
called PPARα, which reduces the
amount of triglycerides and bad
cholesterol made in the body and
increases the good cholesterol.
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'
ch

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO–FENOFIBRATE (FENOFIBRATE) TABLETS
1
NAME OF THE MEDICINE
Fenofibrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fenofibrate is a fibric acid derivative. Chemical name:
2-[4-(4-chlorobenzoyl) phenoxy]-2-
methyl-
propanoic acid, 1-methylethyl ester. The empirical formula is C
20
H
21
O
4
Cl. MW: 360.8.
Fenofibrate
is a white or almost white crystalline powder, stable under ordinary
conditions
and practically insoluble in water. The melting point is 79-82°C.
Fenofibrate 48 mg tablets contain 48 mg of fenofibrate nanoparticles
Fenofibrate 145 mg tablets contain 145 mg of fenofibrate nanoparticles
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Fenofibrate 48 mg tablets are white to off-white biconvex oblong
tablets, ca 10.5 x 5.8 mm,
debossed with “F” on one side and “48” on the other side, in
blister (PVC/PVDC/Al) packs of
60.
Fenofibrate 145 mg tablets are white to off-white biconvex oblong
tablets, ca 15.5 x 8.5
mm, debossed with “F” on one side and “145” on the other side,
in blister (PVC/PVDC/Al)
packs of 30.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults (Dyslipidaemia)
Fenofibrate 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).
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 145 mg and 48 mg tablets should be swallowed whole
with a glass of
water. Fenofibrate 145 mg and 48 mg may be given at any time of the
day,