Ezetimibe Sandoz ezetimibe 10mg tablet blister pack

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

ezetimibe, Quantity: 10 mg

Fáanlegur frá:

Sandoz Pty Ltd

INN (Alþjóðlegt nafn):

Ezetimibe

Lyfjaform:

Tablet

Samsetning:

Excipient Ingredients: hypromellose; lactose monohydrate; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose

Stjórnsýsluleið:

Oral

Einingar í pakka:

30, 5, 10

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Adults (? 18 Years),Primary Hypercholesterolaemia,Ezetimibe administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,Homozygous Familial Hypercholesterolaemia (HoFH),Ezetimibe, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).,Homozygous Sitosterolaemia (Phytosterolaemia),Ezetimibe, is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,Prevention of Cardiovascular Disease,Ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) in need of additional lowering of LDL-C in the expectation of a modest further reduction in risk of cardiovascular events following at least one year therapy (see Section 5.1 Pharmacodynamic properties, Clinical trials),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 co-administered with simvastatin (doses up to 40 mg) is indicated as an 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 co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis)

Vörulýsing:

Visual Identification: 10mg tablets are white to almost white, oval tablets with debossing '10' on one side and EZT on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Leyfisstaða:

Licence status A

Leyfisdagur:

2016-11-24

Upplýsingar fylgiseðill

EZETIMIBE SANDOZ
®
1
EZETIMIBE SANDOZ
®
_ezetimibe _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ezetimibe Sandoz. 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 Ezetimibe
Sandoz 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 EZETIMIBE
SANDOZ IS USED FOR
Ezetimibe Sandoz helps to lower
cholesterol levels. It is used in people
whose cholesterol levels are too high
and when diet alone cannot lower
these levels adequately.
Ezetimibe Sandoz may be taken
alone or with other cholesterol-
lowering medicines known as HMG-
CoA reductase inhibitors (or statins),
in addition to diet.
In people who have high levels of
plant sterols in their blood (which
doctors call sitosterolaemia),
Ezetimibe Sandoz helps to lower
these levels.
_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 EZETIMIBE SANDOZ _
_WORKS _
Ezetimibe Sandoz reduces elevated
total cholesterol, LDL (bad)
cholesterol and triglycerides and
increases HDL (good)

Vara einkenni

211025-Ezetimibe Sandoz-pi
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
EZETIMIBE SANDOZ
® (EZETIMIBE)
1.
NAME OF THE MEDICINE
Ezetimibe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Ezetimibe Sandoz for oral administration contains 10 mg
ezetimibe.
_List of excipients with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Ezetimibe 10 mg, white to almost white oval tablets, debossed with
“10” on one side and
“EZT” on the other side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
_ADULTS (≥ 18 YEARS) _
_PRIMARY HYPERCHOLESTEROLAEMIA _
Ezetimibe administered alone, or with an HMG-CoA reductase inhibitor
(statin), is indicated
as
adjunctive therapy to
diet in patients with primary (heterozygous familial and non-
familial) hypercholesterolaemia.
_HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH) _
Ezetimibe, administered with a statin, is indicated for patients with
HoFH. Patients may also
receive adjunctive treatments (e.g., LDL apheresis).
_HOMOZYGOUS SITOSTEROLAEMIA (PHYTOSTEROLAEMIA) _
Ezetimibe, is indicated for the reduction of elevated sitosterol and
campesterol levels in
patients with homozygous familial sitosterolaemia.
_PREVENTION OF CARDIOVASCULAR DISEASE _
Ezetimibe, is indicated for administration in combination with the
maximum tolerated dose of
a statin with proven cardiovascular benefit in patients with coronary
heart disease (CHD) and
a history of acute coronary syndrome (ACS) in need of additional
lowering of LDL-C in the
expectation of a modest further reduction in risk of cardiovascular
events following at least
one year therapy (see Section 5.1 Pharmacodynamic properties, Clinical
trials)
_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) _
211025-Ezetimibe Sandoz-pi
Page 2 of 28
Ezetimibe co-administered with simvastatin (doses up to 40 mg) is
i