EZETIMIBE/ATORVASTATIN GH 10/80 ezetimibe and atorvastatin (as calcium trihydrate) 10 mg/80 mg tablets blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

atorvastatin calcium trihydrate, Quantity: 82.725 mg (Equivalent: atorvastatin, Qty 80 mg); ezetimibe, Quantity: 10 mg

Disponible depuis:

Lupin Australia Pty Limited

forme pharmaceutique:

Tablet, film coated

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

30's

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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).

Descriptif du produit:

Visual Identification: White to off-white, capsule-shaped, biconvex, film-coated tablet debossed with 'AE' on one side and '4' 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

Statut de autorisation:

Registered

Date de l'autorisation:

2019-11-01

Notice patient

CONSUMER MEDICINE INFORMATION
EZETIMIBE/ATORVASTATIN GH
EZETIMIBE AND ATORVASTATIN (AS CALCIUM TRIHYDRATE)) TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ezetimibe/Atorvastatin GH.
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
Ezetimibe/Atorvastatin GH
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 EZETIMIBE/
ATORVASTATIN GH IS
USED FOR
Ezetimibe/Atorvastatin GH 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),
Ezetimibe/Atorvastatin GH
reduces the risk of heart attack,
stroke, surgery to increase heart
blood flow, or hospitalization for
chest pain.
_HOW _EZETIMIBE/ATORVASTATIN
GH_ WORKS _
Ezetimibe/Atorvastatin GH
contai

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION – EZETIMIBE/ATORVASTATIN GH
(EZETIMIBE AND ATORVASTATIN (AS CALCIUM TRIHYDRATE)) TABLETS
1
NAME OF THE MEDICINE
Ezetimibe.
Atorvastatin (as calcium trihydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ezetimibe/Atorvastatin GH is a film-coated tablet containing ezetimibe
10 mg and atorvastatin 10, 20,
40 or 80 mg.
Ezetimibe/Atorvastatin GH 10/10
:
Each tablet contains 10 mg of ezetimibe and atorvastatin calcium
trihydrate equivalent to 10 mg of
atorvastatin.
Ezetimibe/Atorvastatin GH 10/20
:
Each tablet contains 10 mg of ezetimibe and atorvastatin calcium
trihydrate equivalent to 20 mg of
atorvastatin.
Ezetimibe/Atorvastatin GH 10/40
:
Each tablet contains 10 mg of ezetimibe and atorvastatin calcium
trihydrate equivalent to 40 mg of
atorvastatin.
Ezetimibe/Atorvastatin GH 10/80
:
Each tablet contains 10 mg of ezetimibe and atorvastatin calcium
trihydrate equivalent to 80 mg of
atorvastatin.
Ezetimibe/Atorvastatin GH tablets contain the following excipients:
lactose anhydrous and lactose
monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ezetimibe/Atorvastatin GH 10/10
:
White to off-white, capsule-shaped, biconvex, film-coated tablet
debossed with ‘AE’ on one side and ‘1’
on the other side.
Ezetimibe/Atorvastatin GH 10/20
:
White to off-white, capsule-shaped, biconvex, film-coated tablet
debossed with ‘AE’ on one side and ‘2’
on the other side.
Ezetimibe/Atorvastatin GH 10/40
:
White to off-white, capsule-shaped, biconvex, film-coated tablet
debossed with ‘AE’ on one side and ‘3’
on the other side.
Ezetimibe/Atorvastatin v2.0
Page 2 of 40
(Ezetimibe and atorvastatin (as calcium trihydrate)) tablets
Ezetimibe/Atorvastatin GH 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
Ezetimibe/Atorvastatin GH is indicated in patients with coronary