EZETROL 10 mg TABLET

Krajina: Južná Afrika

Jazyk: angličtina

Zdroj: South African Health Products Regulatory Authority (SAHPRA)

Dostupné z:

Organon South Africa (Pty) Ltd

Dávkovanie:

See ingredients

Forma lieku:

TABLET

Zloženie:

EACH TABLET CONTAINS EZETIMIBE 10,0 mg

Stav Autorizácia:

Registered

Dátum Autorizácia:

2006-06-03

Príbalový leták

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
EZETROL
® 10 MG TABLETS
EZETIMIBE
CONTAINS SUGAR (LACTOSE MONOHYDRATE):
EACH TABLET CONTAINS 55,0 MG OF LACTOSE MONOHYDRATE.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING EZETROL
−
Keep this leaflet. You may need to read it again.
−
If you have further questions, please ask your doctor, pharmacist,
nurse or other
healthcare provider.
−
EZETROL has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What EZETROL is and what it is used for
2.
What you need to know before you take EZETROL
3.
How to take EZETROL
4.
Possible side effects
5.
How to store EZETROL
6.
Contents of the pack and other information
1.
WHAT EZETROL IS AND WHAT IT IS USED FOR
EZETROL is a cholesterol-lowering medicine. It works by decreasing the
absorption of
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cholesterol in the small intestine.
EZETROL reduces elevated total-cholesterol and LDL (bad) cholesterol.
EZETROL may be taken with other cholesterol-lowering medicines known
as statins or
alone, in addition to diet.
EZETROL is for patients whose cholesterol levels are too high and when
diet alone cannot
lower these levels adequately.
For patients with heart disease, EZETROL combined with
cholesterol-lowering medicines
called statins reduces the risk of heart attack, stroke, surgery to
increase heart blood flow or
hospitalisation for chest pain.
Your doctor has prescribed EZETROL to reduce the amount of cholesterol
and triglycerides
in your blood. Cholesterol is one of several fatty substances found in
the bloodstream. Your
total cholesterol is made up mainly of LDL and HDL cholesterol.
Triglycerides are another form of fat in your blood that may increase
your risk for heart
disease.
HOW CAN HIGH CHOLESTEROL BE TREATED?
High cholesterol can be treated in two main ways:
LIFESTYLE CHANGES – including a cholesterol-lowering diet, increased
physical activity and
weight

Súhrn charakteristických

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SCHEDULING STATUS
1
NAME OF THE MEDICINE
EZETROL
®
10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each EZETROL10 mg tablet contains 10 mg of ezetimibe.
EZETROL contains sugar (55,0 mg of lactose monohydrate per tablet).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White to off-white capsule-shaped tablets, debossed with “414” on
one side and plain on the
other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PRIMARY HYPERCHOLESTEROLAEMIA
EZETROL, administered with an HMG-CoA reductase inhibitor (statin) or
alone, is indicated
as adjunctive therapy to diet for the reduction of elevated total
cholesterol (total-C) and low-
density lipoprotein cholesterol (LDL-C), in patients with primary
(heterozygous familial and
non-familial) hypercholesterolaemia.
REDUCTION IN RISK OF CARDIOVASCULAR EVENTS
EZETROL is indicated to reduce the risk of cardiovascular events in
patients with coronary
heart disease (CHD) and a history of acute coronary syndrome (ACS)
when added to
ongoing statin therapy or initiated concomitantly with a statin.
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HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)
EZETROL, administered with a statin, is indicated for the reduction of
elevated total-C and
LDL-C levels in patients with HoFH.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The patient should be on an appropriate lipid-lowering diet and weight
loss program where
indicated and should continue on this diet during treatment with
EZETROL.
POSOLOGY
USE IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLAEMIA
The recommended dose of EZETROL is 10 mg once daily, used alone, with
a statin or with
fenofibrate. EZETROL can be administered at any time of the day, with
or without food.
USE IN PATIENTS WITH CORONARY HEART DISEASE AND ACS EVENT HISTORY
For incremental cardiovascular event reduction in patients with
coronary heart disease and
ACS event history, EZETROL 10 mg may be administered with a statin
with proven
cardiovascular benefit.
SPECIAL POPULATIONS
USE IN PATIENTS WITH RENAL IMPAIR