Zimybe 10/10

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ezetimibe 10mg; Simvastatin 10mg;  

Available from:

Viatris Limited

INN (International Name):

Ezetimibe 10 mg

Dosage:

10mg/10mg

Pharmaceutical form:

Tablet

Composition:

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

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Primary Hypercholesterolaemia Zimybe 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) Zimybe 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, PVC/Aclar/Al - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2013-01-07

Patient Information leaflet

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ZIMYBE
®
10/10,
10/20, 10/40 &
10/80
_EZETIMIBE/SIMVASTATIN TABLETS_
_10MG/10MG, 10MG/20MG, 10MG/40MG & 10MG/80MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking ZIMYBE.
This leaflet answers some common
questions about ZIMYBE.
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 ZIMYBE
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 ZIMYBE IS
USED FOR
ZIMYBE 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.
ZIMYBE contains the active
ingredients ezetimibe and
simvastatin._ _
It works by reducing elevated total
cholesterol, LDL cholesterol and
triglycerides, and increasing HDL
cholesterol.
ZIMYBE works by decreasing the
absorption of cholesterol in the
small intestine and by reducing the
amount of cholesterol made in the
liver. ZIMYBE does not help you to
lose weight.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
This medicine is not addictive.
ZIMYBE IS NOT RECOMMENDED FOR
USE IN CHILDREN UNDER 10 YEARS OF
AGE.
_CHOLESTEROL_
Cholesterol is one of several fatty
substances found in the
bloodstream. Your total cholesterol
is made up mainly of low-density
lipoprotein (LDL) and high-density
lipoprotein (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 narrowing of the
arteries.
This narrowing can slow

Summary of Product characteristics

Page 1 of 42
NEW ZEALAND DATA SHEET
ZIMYBE
® 10/10; ZIMYBE
®
10/20; ZIMYBE
® 10/40 AND
ZIMYBE
® 10/80
1. PRODUCT NAME
ZIMYBE 10/10, ZIMYBE 10/20, ZIMYBE 10/40 or ZIMYBE 10/80, tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 10, 20, 40 or 80 mg of
simvastatin.
Excipient(s) with known effect:
ZIMYBE tablets contain sugars (as lactose).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ZIMYBE 10/10: A white to off-white, oval, biconvex tablet debossed
with M on one side of the tablet
and ES1 on the other side, containing 10 mg ezetimibe and 10 mg
simvastatin.
ZIMYBE 10/20: A white to off-white, oval, biconvex tablet debossed
with M on one side of the tablet
and ES2 on the other side, containing 10 mg ezetimibe and 20 mg
simvastatin.
ZIMYBE 10/40: A white to off-white, oval, biconvex tablet debossed
with M on one side of the tablet
and ES3 on the other side, containing 10 mg ezetimibe and 40 mg
simvastatin.
ZIMYBE 10/80: A white to off-white, oval, biconvex tablet debossed
with M on one side of the tablet
and ES4 on the other side, containing 10 mg ezetimibe and 80 mg
simvastatin.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
PRIMARY HYPERCHOLESTEROLAEMIA
ZIMYBE 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)
ZIMYBE 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).
P