FENOFIBRATE CIPLA fenofibrate 145 mg tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

fenofibrate, Quantity: 145 mg

Disponibil de la:

Cipla Australia Pty Ltd

Forma farmaceutică:

Tablet, film coated

Compoziție:

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

Calea de administrare:

Oral

Unități în pachet:

10 tablets, 30 tablets

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

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

Rezumat produs:

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

Statutul autorizaţiei:

Registered

Data de autorizare:

2018-04-30

Prospect

FENOFIBRATE CIPLA
_48 MG AND 145 MG TABLETS _
_fenofibrate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Fenofibrate Cipla.
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 CIPLA IS
USED FOR
Fenofibrate Cipla 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
Cipla reduces the bad
cholesterol and can actually
raise the good cholesterol.
Fenofibrate Cipla does not
reduce the cholesterol that
comes from fat in food.
Therefore, when you are taking
Fenofibrate Cipla, you also
need t

Caracteristicilor produsului

AUSTRALIAN PRODUCT INFORMATION
FENOFIBRATE CIPLA (FENOFIBRATE) TABLETS
1.
NAME OF THE MEDICINE
Fenofibrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fenofibrate Cipla 48 mg film-coated tablet
Each tablet of Fenofibrate Cipla for oral administration contains 48
mg of fenofibrate.
_Excipients with known effect: _
Contains sugar (as lactose monohydrate).
Fenofibrate Cipla 145 mg film-coated tablet
Each tablet of Fenofibrate Cipla for oral administration contains 145
mg of fenofibrate
_Excipients with known effect: _
Contains sugars (as lactose and sucrose).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Fenofibrate Cipla 48 mg film-coated tablet
Fenofibrate Cipla 48 mg film-coated tablets are yellow coloured, oval
shaped, biconvex film-coated
tablet, debossed with ‘cipla’ on one side and code '459' on other
side.
Fenofibrate Cipla 145 mg film-coated tablet
Fenofibrate Cipla 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
THERAPEUTIC INDICATIONS
Fenofibrate Cipla 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 Cipla is presented as a 145 mg and 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 section 4.2 DOSE
AND METHOD OF
ADMINISTRATION-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
Cipla 145 mg and 48 mg tablets should be swallowed whole with a glass
of water. Fenofibrate Cipla
145 mg and 48 mg ta