ATOZET ezetimibe/atorvastatin 10mg/20mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

atorvastatin calcium trihydrate, Quantity: 21.7 mg (Equivalent: atorvastatin, Qty 20 mg); ezetimibe, Quantity: 10 mg

Beschikbaar vanaf:

ORGANON PHARMA PTY LTD

INN (Algemene Internationale Benaming):

atorvastatin calcium trihydrate,Ezetimibe

farmaceutische vorm:

Tablet, multilayer

Samenstelling:

Excipient Ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; polysorbate 80; sodium lauryl sulfate; silicon dioxide; povidone; magnesium stearate; hyprolose; titanium dioxide; macrogol 8000; hypromellose; purified talc

Toedieningsweg:

Oral

Eenheden in pakket:

30, 10

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Prevention of Cardiovascular Disease ATOZET 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 (see Clinical Trials). Primary Hypercholesterolaemia ATOZET 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) ATOZET is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).

Product samenvatting:

Visual Identification: Capsule shaped, biconvex, white to off white tablets, with "333" debossed on one side of the tablet; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Autorisatie-status:

Licence status A

Autorisatie datum:

2015-02-04

Bijsluiter

ATOZET
®
_ezetimibe and atorvastatin calcium trihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Atozet. 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 Atozet 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 ATOZET IS USED
FOR
Atozet 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), Atozet reduces the risk
of heart attack, stroke, surgery to
increase heart blood flow, or
hospitalization for chest pain.
_HOW ATOZET WORKS_
Atozet contains two different
medicines. One is Ezetrol (ezetimibe)
and the other is atorvastatin
(atorvastatin calcium trihydrate).
Atozet reduces elevated total-
cholest

Productkenmerken

ATOZET PI A190418 v5.0
S-CCDS-MK0653C-T-122018
Page 1 of 37
AUSTRALIAN PRODUCT INFORMATION
ATOZET
®
(EZETIMIBE, ATORVASTATIN (AS CALCIUM TRIHYDRATE)) TABLETS
1
NAME OF THE MEDICINE
Ezetimibe
Atorvastatin (as calcium trihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATOZET 10 mg/10 mg containing ezetimibe 10 mg and atorvastatin (as
calcium trihydrate) 10
mg
ATOZET 10 mg/20 mg containing ezetimibe 10 mg and atorvastatin (as
calcium trihydrate) 20
mg
ATOZET 10 mg/40 mg containing ezetimibe 10 mg and atorvastatin (as
calcium trihydrate)
40 mg
ATOZET 10 mg/80 mg containing ezetimibe 10 mg and atorvastatin (as
calcium trihydrate) 80
mg
ATOZET is available for oral use as tablets containing 10 mg of
ezetimibe and: 10.9 mg of
atorvastatin calcium trihydrate, equivalent to 10 mg of atorvastatin
(ATOZET 10 mg/10 mg);
21.7 mg of atorvastatin calcium trihydrate, equivalent to 20 mg of
atorvastatin (ATOZET 10
mg/20 mg); 43.4 mg of atorvastatin calcium trihydrate, equivalent to
40 mg of atorvastatin
(ATOZET 10 mg/40 mg); or 86.8 mg of atorvastatin calcium trihydrate,
equivalent to 80 mg of
atorvastatin (ATOZET 10 mg/80 mg).
List of excipients with known effect:
-
lactose (as monohydrate)
For full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ATOZET is a film-coated tablet containing ezetimibe 10 mg and
atorvastatin 10, 20, 40 or 80
mg.
ATOZET 10/10 contains 10 mg of ezetimibe and 10.9 mg of atorvastatin
calcium trihydrate,
equivalent to 10 mg of atorvastatin. The tablets are white to
off-white capsule-shaped,
biconvex, film-coated with code 257 on one side and plain on the
other.
ATOZET 10/20 contains 10 mg of ezetimibe and 21.7 mg of atorvastatin
calcium trihydrate,
equivalent to 20 mg of atorvastatin. The tablets are white to
off-white capsule-shaped,
biconvex, film-coated with code 333 on one side and plain on the
other.
ATOZET 10/40 contains 10 mg of ezetimibe and 43.4 mg of atorvastatin
calcium trihydrate,
equivalent to 40 mg of atorvastatin. The tablets are white to
off-white capsule