Ezetimibe 10 mg tablets

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Ezetimibe

Հասանելի է:

Accord Healthcare Ireland Ltd.

ATC կոդը:

C10AX; C10AX09

INN (Միջազգային անվանումը):

Ezetimibe

Դոզան:

10 milligram(s)

Դեղագործական ձեւ:

Tablet

Ռեկվիզորի տեսակը:

Product subject to prescription which may be renewed (B)

Թերապեւտիկ տարածք:

Other lipid modifying agents; ezetimibe

Լիազորման կարգավիճակը:

Not marketed

Հաստատման ամսաթիվը:

2017-03-10

Տեղեկատվական թերթիկ

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. 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.
Ezetimibe lowers levels of total cholesterol, "bad" cholesterol (LDL
cholesterol), and
fatty substances called triglycerides in the blood. In addition,
Ezetimibe raises levels
of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient 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

Ապրանքի հատկությունները

Health Products Regulatory Authority
04 March 2019
CRN008NW4
Page 1 of 15
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 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_
Ezetimib, 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.
Ezetimib 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_
Ezetimib 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)_
Ezetimib 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 Ezetimib.
Route of administration is oral. The recommended dose is one Ezetimib
10 mg tablet daily. Ezetimib can be administered at
any time of the day, with or without food.
When Ezetimib is added to a statin, either the indicated us