EzSimva GH 10/20 ezetimibe 10 mg and simvastatin 20 mg tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

simvastatin, Quantity: 20 mg; ezetimibe, Quantity: 10 mg

Disponible depuis:

Torrent Australasia Pty Ltd

forme pharmaceutique:

Tablet

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

5, 30, 10

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Adults (greater than or equal to 18 years),Prevention of Cardiovascular Disease,EzSimva GH 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,EzSimva GH 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),EzSimva GH s 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),EzSimva GH 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),EzSimva GH is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).

Descriptif du produit:

Visual Identification: Light pink to pink colored with mosaic appearance, capsule shaped biconvex uncoated tablets 336 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

Statut de autorisation:

Registered

Date de l'autorisation:

2019-10-15

Notice patient

CONSUMER MEDICINE INFORMATION
EZSIMVA GH
(EZETIMIBE AND SIMVASTATIN) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
EzSimva 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
EzSimva 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 EZSIMVA GH IS
USED FOR
EzSimva GH 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 EZSIMVA GH WORKS _
EzSimva GH reduces elevated
total cholesterol, LDL (bad)
cholesterol and triglycerides and
increases HDL (good)
cholesterol.
EzSimva GH works by
decreasing the absorption of
cholesterol in the small intestine
and by reducing the amount of
cholesterol made in the liver.
EzSimva GH does not help you
lose weight.
If you have heart disease and a
history of heart attack or
hospitalisation for unstable
angina (chest pain), EzSimva
GH reduc

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION – EZSIMVA GH 10/10, EZSIMVA GH
10/20, EZSIMVA GH 10/40, EZSIMVA GH 10/80
(
Ezetimibe and Simvastatin
)
1
NAME OF THE MEDICINE
Ezetimibe
Simvastatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EzSimva GH is available for oral use as tablets containing:
•
10 mg of ezetimibe and 10 mg of simvastatin (EzSimva GH 10/10);
•
10 mg of ezetimibe and 20 mg of simvastatin (EzSimva GH 10/20);
•
10 mg of ezetimibe and 40 mg of simvastatin (EzSimva GH 10/40); or
•
10 mg of ezetimibe and 80 mg of simvastatin (EzSimva GH 10/80).
List of excipients with known effect:
•
lactose (as monohydrate)
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablets
EzSimva GH 10/10: [10mg Ezetimibe/ 10mg Simvastatin]: Light pink to
pink colored with mosaic
appearance, capsule shaped biconvex uncoated tablets ‘335’ on one
side and plain on other side.
EzSimva GH 10/20 [10mg Ezetimibe/ 20mg Simvastatin]: Light pink to
pink colored with mosaic
appearance, capsule shaped biconvex uncoated tablets ‘336’ on one
side and plain on other side.
EzSimva GH 10/40 [10mg Ezetimibe/ 40mg Simvastatin]: Light pink to
pink colored with mosaic
appearance, capsule shaped biconvex uncoated tablets ‘337’ on one
side and plain on other side.
EzSimva GH 10/80 [10mg Ezetimibe/ 80mg Simvastatin]: Light pink to
pink colored with mosaic
appearance, capsule shaped biconvex uncoated tablets ‘338’ on one
side and plain on other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS (≥18 YEARS)
PREVENTION OF CARDIOVASCULAR DISEASE
EzSimva GH 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
Page 2 of 44
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
E