Ezetimibe 10mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Ezetimibe

Доступна с:

Alliance Healthcare (Distribution) Ltd

код АТС:

C10AX09

ИНН (Международная Имя):

Ezetimibe

дозировка:

10mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 02120000

тонкая брошюра

Proof no.
Colours:
Dimensions:
Date prepared:
Font size:
Fonts:
010.0
07/02/2019
10pt
Black
165 x 620 mm
FuturaCEEF
ARTWORK PROOF BOX
Ref:
V022: Change in pharmaceutical form & change to inprocess tests
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.

Характеристики продукта

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 with known effect: Each tablet contains 63 mg of lactose
monohydrate.
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off white, capsule shaped tablets, 8 mm x 4 mm in size,
debossed with
“713” on one side and plain 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 already establis