ZEKLEN 10 mg/20 mg 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:

ORGANON PHARMA PTY LTD

DCI (Dénomination commune internationale):

Ezetimibe,Simvastatin

forme pharmaceutique:

Tablet, uncoated

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

10 tablets, 30 tablets, 5 tablets

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Adults (greater than or equal to 18 years),Prevention of cardiovascular disease,ZEKLEN 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,ZEKLEN 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),ZEKLEN is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., 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),ZEKLEN is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia 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),ZEKLEN is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Descriptif du produit:

Visual Identification: White to off-white, capsule shaped, biconvex compressed tablet with "312" marked on the tablet; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

2015-11-25

Notice patient

ZEKLEN
®
_Ezetimibe/Simvastatin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZEKLEN. 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 ZEKLEN
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 ZEKLEN IS USED
FOR
ZEKLEN 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 ZEKLEN WORKS_
ZEKLEN reduces elevated total-
cholesterol, LDL (bad) cholesterol
and triglycerides and increases HDL
(good) cholesterol.
ZEKLEN works by decreasing the
absorption of cholesterol in the small
intestine and by reducing the amount
of cholesterol made in the liver.
ZEKLEN does not help you lose
weight.
If you have heart disease and a
history of heart attack or
hospitalisation for unstable angina
(chest pain), ZEKLEN reduces the
risk of heart attack, stroke, surgery to
increase h

Résumé des caractéristiques du produit

Page 1 of 40
AUSTRALIAN PRODUCT INFORMATION
ZEKLEN
®
(EZETIMIBE AND SIMVASTATIN)
TABLETS
1
NAME OF THE MEDICINE
Ezetimibe
Simvastatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZEKLEN is available for oral use as tablets containing 10 mg of
ezetimibe, and 10 mg of
simvastatin (ZEKLEN 10/10), 20 mg of simvastatin (ZEKLEN 10/20), 40 mg
of simvastatin
(ZEKLEN 10/40), or 80 mg of simvastatin (ZEKLEN 10/80).
EZETIMIBE
Ezetimibe is a white, crystalline powder that is freely to very
soluble in ethanol, methanol, and
acetone and practically insoluble in water.
SIMVASTATIN
Simvastatin is a white to off-white, non-hygroscopic, crystalline
powder that is practically
insoluble in water, and freely soluble in chloroform, methanol and
ethanol.
List of excipients with known effects:
-
lactose (as monohydrate)
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ZEKLEN is available in the following presentations:
ZEKLEN 10/10: [10mg Ezetimibe/ 10mg Simvastatin]: White to off-white,
capsule shaped,
biconvex compressed tablet marked with “311”.
ZEKLEN 10/20 [10mg Ezetimibe/ 20mg Simvastatin]: White to off-white,
capsule shaped,
biconvex compressed tablet marked with “312”.
ZEKLEN 10/40 [10mg Ezetimibe/ 40mg Simvastatin]: White to off-white,
capsule shaped,
biconvex compressed tablet marked with “313”.
ZEKLEN 10/80 [10mg Ezetimibe/ 80mg Simvastatin]: White to off-white,
capsule shaped,
biconvex compressed tablet marked with “315”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Page 2 of 40
_ADULTS (≥18 YEARS) _
_ _
_PREVENTION OF CARDIOVASCULAR DISEASE _
ZEKLEN 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 HYPERCHOLESTEROLA