EZETIMIBE/SIMVASTATIN-MEDIS 10/10 ezetimibe/simvastatin 10/10 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Medis Pharma Pty Ltd

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults (?18 years),Prevention of Cardiovascular Disease EZETIMIBE/SIMVASTATIN-MEDIS 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 Clinical Trials).,Primary Hypercholesterolaemia EZETIMIBE/SIMVASTATIN-MEDIS 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) EZETIMIBE/SIMVASTATIN-MEDIS 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) EZETIMIBE/SIMVASTATIN-MEDIS 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) EZETIMIBE/SIMVASTATIN-MEDIS is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Product summary:

Visual Identification: Light tan, mottled, round about 6 mm, biconvex tablet. Marking 511 on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-11-06

Summary of Product characteristics

Ezetimibe/simvastatin 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg tablets
PRODUCT INFORMATION
Medis Pharma Pty Ltd
EZETIMIBE/SIMVASTATIN-MEDIS PI 0817 V4
Page 1 of 43
PRODUCT INFORMATION
EZETIMIBE/SIMVASTATIN-MEDIS
(ezetimibe and simvastatin)
NAME OF THE MEDICINE
_EZETIMIBE_
Chemical name:
1-(4-fluorophenyl)-3(_R_)-[3-(4-fluorophenyl)-3(_S_)-
hydroxypropyl]-
4(_S_)-
(4-hydroxyphenyl)-2-azetidinone.
Molecular formula:
C
24
H
21
F
2
NO
3
Molecular weight:
409.4
CAS registry number: 163222-33-1
Structural formula:
_SIMVASTATIN_
Chemical name:
Simvastatin, an inactive lactone, is hydrolysed to the corresponding
β-hydroxyacid form,
which is an inhibitor of HMG-CoA reductase. Simvastatin is
(1_S_,3_R_,7_S_,8_S_,8a_R_)-8-[2-
[(2_R_,4_R_)-4-Hydroxy-6-oxotetrahydro-2_H_-pyran-2-yl]ethyl]-3-7-dimethyl-
1,2,3,7,8,8ahexahydronaphtalen-1-yl 2,2-dimethylbutonate..
Molecular formula:
C
25
H
38
O
5
Molecular weight:
418.57
CAS registry number: 79902-63-9
Structural formula:
Ezetimibe/simvastatin 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg tablets
PRODUCT INFORMATION
Medis Pharma Pty Ltd
EZETIMIBE/SIMVASTATIN-MEDIS PI 0817 V4
Page 2 of 43
DESCRIPTION
Ezetimibe is a white, crystalline powder that is freely to very
soluble in ethanol, methanol,
and acetone and practically insoluble in water.
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.
EZETIMIBE/SIMVASTATIN-MEDIS (ezetimibe/simvastatin) is a
lipid-lowering product that
selectively inhibits the intestinal absorption of cholesterol and
related plant sterols and
inhibits the endogenous synthesis of cholesterol.
EZETIMIBE/SIMVASTATIN-MEDIS is available for oral use as tablets
containing 10 mg of
ezetimibe, and 10 mg of simvastatin (EZETIMIBE/SIMVASTATIN-MEDIS
10/10), 20 mg of
simvastatin
(EZETIMIBE/SIMVASTATIN-MEDIS
10/20),
40
mg
of
simvastatin
(EZETIMIBE/SIMVASTATIN-MEDIS
10/40),
or
80
mg
of
simvastatin
(EZETIMIBE/SIMVASTATIN-MEDIS 10/80).
Each tablet contains the followi