Ezetimibe 10mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Ezetimibe

Commercializzato da:

DE Pharmaceuticals

Codice ATC:

C10AX09

INN (Nome Internazionale):

Ezetimibe

Dosaggio:

10mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 02120000

Foglio illustrativo

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. See section 4.
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 is a medicine to lower increased levels of cholesterol.
This medicine 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 ingredient of this medicine works by reducing
the cholesterol absorbed in your digestive
tract.
This medicine 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.
Tri

Scheda tecnica

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