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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Ezetimibe 10 mg tablets
Ezetimibe
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Ezetimibe is and what it is used for
2. What you need to know before you take Ezetimibe
3. How to take Ezetimibe
4. Possible side effects
5. How to store Ezetimibe
6. Contents of the pack and other information
1. WHAT EZETIMIBE IS AND WHAT IT IS USED FOR
_ _
Ezetimibe contains the active substance ezetimibe.
Ezetimibe is a medicine used to lower levels of total cholesterol,
"bad" cholesterol (LDL
cholesterol), and fatty substances called triglycerides in the blood.
In addition, this medicine raises
levels of "good" cholesterol (HDL cholesterol). It is used for
patients who cannot control their
cholesterol levels by diet alone. You should stay on a
cholesterol-lowering diet while taking this
medicine.
This medicine works by reducing the cholesterol absorbed in your
digestive tract. It does not help
you lose weight.
Ezetimibe adds to the cholesterol-lowering effect of statins, a group
of medicines that reduce the
cholesterol your body makes by itself.
Ezetimibe is used in addition to diet if you have:
a raised cholesterol level in your blood (primary
hypercholesterolaemia [heterozygous familial
and non-familial])
This medicine can be taken
-
together with a statin, when your cholesterol level is not well
controlled with a stati
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ezetimibe, 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipient(s) with known effect: 68 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL
FORM
Tablet
White to almost white, oval tablets (7.4 mm x 4.1 mm) with
debossing “10” on one side and “EZT”
on the other side.
4. CLINICAL
PARTICULARS
4.1 THERAPEUTIC
INDICATIONS
_Primary hypercholesterolaemia _
_ _
Ezetimibe, co-administered with an HMG-CoA reductase inhibitor
(statin) is indicated as
adjunctive therapy to diet for use in patients with primary
(heterozygous familial and non-familial)
hypercholesterolaemia who are not appropriately controlled with a
statin alone.
Ezetimibe monotherapy is indicated as adjunctive therapy to diet for
use in patients with primary
(heterozygous familial and non-familial) hypercholesterolaemia in
whom a statin is considered
inappropriate or is not tolerated.
_Homozygous Familial Hypercholesterolaemia (HoFH) _
_ _
Ezetimibe co-administered with a statin, is indicated as adjunctive
therapy to diet for use in patients
with HoFH. Patients may also receive adjunctive treatments (e.g. LDL
apheresis).
_Homozygous sitosterolaemia (phytosterolaemia) _
_ _
Ezetimibe is indicated as adjunctive therapy to diet for use in
patients with homozygous familial
sitosterolaemia.
A beneficial effect of Ezetimibe on cardiovascular morbidity and
mortality has not yet been
demonstrated.
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The patient should be on an appropriate lipid lowering diet and should
continue on this diet during
treatment with Ezetimibe.
Route of administration is oral. The recommended dose is one Ezetimibe
10 mg tablet daily.
Ezetimibe can be administered at any time of
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