Ezetimibe 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ezetimibe

Available from:

Sandoz Ltd

ATC code:

C10AX09

INN (International Name):

Ezetimibe

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5050650955019

Patient Information leaflet

Ezetimibe is a medicine to lower increased levels of
cholesterol.
Ezetimibe lowers 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).
Ezetimibe, the active substance of Ezetimibe, works
by reducing the cholesterol absorbed in your
digestive tract.
Ezetimibe adds to the cholesterol-lowering effect of
statins, a group of medicines that reduce the
cholesterol your body makes by itself.
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 are another form of fat in your blood
that may increase your risk for heart disease.
This medicine is used for patients who cannot control
their cholesterol levels by cholesterol-lowering diet
alone. You should stay on a cholesterol-lowering
diet while taking this medicine.
Ezetimibe is used in addition to your
cholesterol-lowering diet if you have:
• a raised cholesterol level in your blood
(primary hypercholesterolaemia [heterozygous
familial and non-familial])
-
together with a statin, when your cholesterol
level is not well controlled with a statin alone
-
alone, when statin treatment is
inappropriate or is not tolerated.
• a hereditary illness (homozygous familial
hypercholesterolaemia) that increases the
cholesterol level in your blood. You will also be
prescribed a statin and may also receive other
treatments.
If you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ezetimibe 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipient(s) with known effect
Each tablet contains 64.1 mg of lactose (as 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 4.0 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.
_PREVENTION OF CARDIOVASCULAR EVENTS _
_Ezetimibe_ is indicated to reduce the risk of cardiovascular events
(see section
5.1) 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.
_ _
_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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 the day,
with or
without food.
When Ezetimibe is added to a statin, either the indicated usual
initial dose of
that particular statin or the a