FENOCOL fenofibrate 145 mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

fenofibrate, Quantity: 145 mg

Disponible des:

Arrotex Pharmaceuticals Pty Ltd

formulario farmacéutico:

Tablet, film coated

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

30 Tablets, 10 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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

Resumen del producto:

Visual Identification: White to off white coloured, oval biconvex film coated tablet debossed with Cipla on one side and code 458 on other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estat d'Autorització:

Registered

Data d'autorització:

2018-04-30

Informació per a l'usuari

FENOCOL
_Fenofibrate _
_145 MG FILM-COATED TABLETS _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Fenocol.
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
FENOCOL IS USED FOR
Fenocol 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, Fenocol
reduces the bad cholesterol and
can actually raise the good
cholesterol.
Fenocol does not reduce the
cholesterol that comes from fat
in food.
Therefore, when you are taking
Fenocol, you also need to
follow a low-fat diet and other
measures, such as exercise and

Fitxa tècnica

1
AUSTRALIAN PRODUCT INFORMATION
FENOCOL (FENOFIBRATE) TABLETS
1
NAME OF THE MEDICINE
Fenofibrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fenocol 145 mg tablets contain 145 mg of fenofibrate
Excipients with known effect: Contains sugars as sucrose and lactose
monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Fenocol 145 mg film-coated tablets are white to off white coloured,
oval shaped, biconvex
film coated tablet, debossed with 'cipla' on one side and code '458'
on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Fenocol 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
D
OSE AND METHOD OF ADMINISTRATION
NOTE:
A lower strength fenofibrate 48 mg tablets can be available from other
brand/s.
Adults (Dyslipidaemia)
Fenocol 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 Renal Impairment
sub-heading
below).
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. Fenocol 145 mg tablets should be swallowed whole with a glass of
water. Fenocol 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 same time each day. Dietary measures instituted
before therapy should
be continued.
2
Elderly
In elderly patients without renal impairment, the normal adult dose is
recommended.
Renal Impairment
Dosage reduction is required in patients with renal impairment.
In moderate renal dysfunction (eGFR between 30 and 60ml/min/1.73m
2
or creatinine
clearance between 30 and 60mL/min) start with one fenofibrate 48mg
tablet once daily. The
dose may be increased to two fenofibr