Vytorin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ezetimibe 10mg; Simvastatin 10mg

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Ezetimibe 10 mg

Dosage:

10/10mg

Pharmaceutical form:

Tablet

Composition:

Active: Ezetimibe 10mg Simvastatin 10mg Excipient: Butylated hydroxyanisole Citric acid monohydrate Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Propyl gallate

Units in package:

Blister pack, Al, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

MSD International GmbH (Singapore Branch)

Therapeutic indications:

Homozygous familial hypercholesterolaemia VYTORIN is indicated for the reduction of elevated total-C and LDL-C levels in adult and adolescent (10 to 17 years of age) patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Product summary:

Package - Contents - Shelf Life: Blister pack, Al - 10 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 10 tablets - 18 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 30 tablets - 18 months from date of manufacture stored at or below 25°C

Authorization date:

2003-10-10

Patient Information leaflet

VYTORIN
®
 tablets 
Page 1 of 9 
NEW ZEALAND CONSUMER MEDICINE INFORMATION 
VYTORIN
®

_ezetimibe/simvastatin _
10/10 mg, 10/20 mg, 10/40 mg & 10/80 mg tablets 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about VYTORIN.  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 
VYTORIN 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 VYTORIN IS USED FOR 
VYTORIN helps to lower high LDL
(bad) cholesterol and triglyceride levels, and raises 
levels of HDL (good) cholesterol.  VYTORIN is for adults and
adolescents (10 to 17 years 
of age) who
cannot control their cholesterol levels by diet alone.  You
should stay on a 
cholesterol-lowering diet while taking this medicine. 

Everyone has cholesterol and triglycerides in
their blood.  They are types of blood fat 
needed by the body for many things. 
CHOLESTEROL 
Some of the reasons cholesterol is needed by the
body include; building cell walls making 
bile acids (which help to digest food) and certain hormones. 
However, too much 
cholesterol can be a problem. 

Your body makes cholesterol, but it also comes from food. 

Normally the body balances the cholesterol it makes with the
cholesterol it gets from food.  
This means if more cholesterol comes from food, less is made
by the body.  However, if 
you eat a diet high in fat, your body may not keep
this balance and your cholesterol levels 
rise. 

High cholesterol is more likely to occur with certain
diseases or if you have a family history 
of�

Summary of Product characteristics

VYTORIN Datasheet A20130212v5 
Page 1 of 19 
(0653A-NZL-2012-005584/ 0653A-NZL-2013-005641) 

NAME OF MEDICINE 
VYTORIN
®

_ezetimibe/simvastatin _
10/10 mg, 10/20 mg, 10/40 mg & 10/80 mg tablets 
PRESENTATION 
10/10 mg tablet:  A white to off white, capsule
shaped, biconvex compressed tablet marked 311 on 
one side.  Dimensions are 8.48 mm x 4.24 mm. 
10/20 mg tablet:  A white to off white, capsule
shaped, biconvex compressed tablet marked 312 on 
one side.  Dimensions are 10.66 mm x 5.33 mm. 
10/40 mg tablet:  A white to off white, capsule
shaped, biconvex compressed tablet marked 313 on 
one side.  Dimensions are 13.86 mm x 5.98 mm. 
10/80 mg tablet:  A white to off white, capsule
shaped, biconvex compressed tablet marked 315 on 
one side.  Dimensions are 17.46 mm x 7.53 mm. 
THERAPEUTIC CLASS 
VYTORIN
(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. 
INDICATIONS 
PRIMARY HYPERCHOLESTEROLAEMIA 
VYTORIN is indicated as adjunctive therapy to diet for the
reduction of elevated total cholesterol 
(total-C), low-density lipoprotein
cholesterol (LDL-C), apolipoprotein B (Apo
B), triglycerides (TG), 
and non-high-density lipoprotein cholesterol (non-HDL-C), and to
increase high-density lipoprotein 
cholesterol (HDL-C) in adult and adolescent (10 to 17
years of age) patients with primary 
(heterozygous familial and non-familial) hypercholesterolaemia
or mixed hyperlipidaemia in 
patients not adequately treated on a statin alone. 
HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH) 
VYTORIN is indicated for the reduction of elevated total-C and
LDL-C levels in adult and 
adolescent (10 to 17 years of age) patients with HoFH. 
Patients may also receive adjunctive 
treatments (e.g., LDL apheresis). 
DOSAG