Ezetimibe 10mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Ezetimibe

Tersedia dari:

Medical Valley Invest AB

Kode ATC:

C10AX09

INN (Nama Internasional):

Ezetimibe

Dosis:

10mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 02120000; GTIN: 5060570900280

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETROL
® 10 MG TABLETS
EZETIMIBE
The name of your medicine is Ezetrol 10 mg Tablets however, will be
referred to as Ezetrol throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
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
EZETROL is a medicine to lower increased levels of cholesterol.
EZETROL lowers levels of total cholesterol, "bad" cholesterol (LDL
cholesterol), and fatty substances called triglycerides in the blood.
In
addition, EZETROL raises levels of "good" cholesterol (HDL
cholesterol).
Ezetimibe, the active ingredient of EZETROL, works by reducing the
cholesterol absorbed in your digestive tract.
EZETROL 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.
It is used for patients who cannot control their cholesterol levels by
cholesterol lowering diet alone. You should stay on your cholesterol
lowering diet while taking this medicine.
_EZETROL is used in addit

Karakteristik produk

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