EZEVYT 10/40 ezetimibe 10 mg and simvastatin 40 mg tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

ezetimibe, Quantity: 10 mg; simvastatin, Quantity: 40 mg

Dostępny od:

Torrent Australasia Pty Ltd

Forma farmaceutyczna:

Tablet

Skład:

Excipient Ingredients: ferric oxide; propyl gallate; microcrystalline cellulose; lactose monohydrate; citric acid monohydrate; ascorbic acid; hypromellose; butylated hydroxyanisole; magnesium stearate; croscarmellose sodium

Droga podania:

Oral

Sztuk w opakowaniu:

10, 5, 30

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Adults (greater than or equal to 18 years),Prevention of Cardiovascular Disease,EZEVYT is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin 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 Section 5.1 Pharmacodynamic Properties - Clinical Trials),Primary Hypercholesterolaemia,EZEVYT is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:,? Patients not appropriately controlled with a statin or ezetimibe alone. ? Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH),EZEVYT is indicated in patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).,Children and Adolescents 10-17 years (pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche),Heterozygous Familial Hypercholesterolaemia (HeFH),EZEVYT is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with HeFH where use of a combination product is appropriate:,? Patients not appropriately controlled with a statin or ezetimibe alone. ? Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH),EZEVYT is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).

Podsumowanie produktu:

Visual Identification: Light pink to pink colored with mosaic appearance, capsule shaped biconvex uncoated tablets 337 on one side and plain on 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

Status autoryzacji:

Registered

Data autoryzacji:

2019-10-15

Ulotka dla pacjenta

1
EZEVYT 10/10, EZEVYT 10/20, EZEVYT 10/40 AND EZEVYT 10/80
_Ezetimibe/Simvastatin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EZEVYT.
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 EZEVYT
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 EZEVYT
IS USED FOR
EZEVYT helps to lower cholesterol
and triglyceride levels. It is used in
people whose cholesterol levels are
too high and when diet alone cannot
lower these levels adequately.
_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.
_HOW EZEVYT WORKS_
_ _
EZEVYT reduces elevated total-
cholesterol, LDL (bad) cholesterol
and triglycerides and increases HDL
(good) cholesterol.
EZEVYT works by decreasing the
absorption of cholesterol in the small
intestine and by reducing the amount
of cholesterol made in the liver.
EZEVYT does not help you
lose weight.
If you have heart disease and a
history of heart attack or
hospitalisation for unstable angina
(chest pain), EZEVYT reduces t