Ezetast 10/10 ezetimibe and atorvastatin (as calcium trihydrate) 10 mg/10 mg tablets blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

atorvastatin calcium trihydrate, Quantity: 10.341 mg (Equivalent: atorvastatin, Qty 10 mg); ezetimibe, Quantity: 10 mg

זמין מ:

Lupin Australia Pty Limited

טופס פרצבטיות:

Tablet, film coated

הרכב:

Excipient Ingredients: crospovidone; sodium stearylfumarate; lactose; povidone; sodium lauryl sulfate; colloidal anhydrous silica; microcrystalline cellulose; lactose monohydrate; calcium carbonate; hyprolose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

30's

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Prevention of Cardiovascular Disease Ezetimibe/Atorvastatin is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy,Primary Hypercholesterolaemia Ezetimibe/Atorvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: ? not appropriately controlled with atorvastatin or ezetimibe alone; or ? already treated with atorvastatin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH) Ezetimibe/Atorvastatin is indicated in patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).

leaflet_short:

Visual Identification: White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with 'AE' on one side and '1' on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Registered

תאריך אישור:

2019-11-01

עלון מידע

CONSUMER MEDICINE INFORMATION
EZETAST
EZETIMIBE AND ATORVASTATIN (AS CALCIUM TRIHYDRATE)) TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
EZETAST.
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
EZETAST 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 EZETAST IS USED
FOR
EZETAST helps to lower
cholesterol and triglyceride
levels. It is used in people
whose cholesterol and
triglyceride levels are too high
and when diet alone cannot
lower these levels adequately.
_WHAT IS HIGH CHOLESTEROL_
Cholesterol is one of several
fatty substances found in the
bloodstream. Your total
cholesterol is made up
mainly of LDL and HDL
cholesterol.
LDL cholesterol is often called
"bad" cholesterol because it can
build up in the walls of your
arteries forming plaque.
Eventually this plaque build up
can lead to a narrowing of the
arteries. This narrowing can
slow or block blood flow to vital
organs such as the heart and
brain. This blocking of blood flow
can result in a heart attack or
stroke.
HDL cholesterol is often called
"good" cholesterol because it
helps keep the bad cholesterol
from building up in the arteries
and protects against heart
disease.
_TRIGLYCERIDES _
Triglycerides are another form of
fat in your blood that may
increase your risk for heart
disease.
_HEART DISEASE _
If you have heart disease and a
history of heart attack or
hospitalisation for unstable
angina (chest pain), EZETAST
reduces the risk of heart attack,
stroke, surgery to increase heart
blood flow, or hospitalization for
chest pain.
_HOW _EZETAST_ WORKS _
EZETAST contains two different
medicines. One is Ezetrol
(ezetimibe) and the other is
atorvastatin (atorvastatin
calcium trihydrate). EZETAST
reduces elevated

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION – EZETAST
(EZETIMIBE AND ATORVASTATIN (AS CALCIUM TRIHYDRATE)) TABLETS
1
NAME OF THE MEDICINE
Ezetimibe.
Atorvastatin (as calcium trihydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EZETAST is a film-coated tablet containing ezetimibe 10 mg and
atorvastatin 10, 20, 40 or 80 mg.
EZETAST 10/10
:
Each tablet contains 10 mg of ezetimibe and atorvastatin calcium
trihydrate equivalent to 10 mg of
atorvastatin.
EZETAST 10/20
:
Each tablet contains 10 mg of ezetimibe and atorvastatin calcium
trihydrate equivalent to 20 mg of
atorvastatin.
EZETAST 10/40
:
Each tablet contains 10 mg of ezetimibe and atorvastatin calcium
trihydrate equivalent to 40 mg of
atorvastatin.
EZETAST 10/80
:
Each tablet contains 10 mg of ezetimibe and atorvastatin calcium
trihydrate equivalent to 80 mg of
atorvastatin.
Excipients with known effect: contains sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
EZETAST 10/10
:
White to off-white, capsule-shaped, biconvex, film-coated tablet
debossed with ‘AE’ on one side and ‘1’
on the other side.
EZETAST 10/20
:
White to off-white, capsule-shaped, biconvex, film-coated tablet
debossed with ‘AE’ on one side and ‘2’
on the other side.
EZETAST 10/40
:
White to off-white, capsule-shaped, biconvex, film-coated tablet
debossed with ‘AE’ on one side and ‘3’
on the other side.
Ezetast v2.0
Page 2 of 39
(Ezetimibe and atorvastatin (as calcium trihydrate)) tablets
EZETAST 10/80
:
White to off-white, capsule-shaped, biconvex, film-coated tablet
debossed with ‘AE’ on one side and
on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PREVENTION OF CARDIOVASCULAR DISEASE
EZETAST is indicated in patients with coronary heart disease (CHD) and
a history of acute coronary
syndrome (ACS) taking their maximum tolerated dose of atorvastatin and
in need of additional lowering
of LDL-C in the expectation of a modest further reduction in the risk
of cardiovascular events following
at lea