Ezetimibe 10mg Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Ezetimibe

Διαθέσιμο από:

Key Pharmaceuticals Ltd

Φαρμακολογική κατηγορία (ATC):

C10AX; C10AX09

INN (Διεθνής Όνομα):

Ezetimibe

Δοσολογία:

10 milligram(s)

Φαρμακοτεχνική μορφή:

Tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Other lipid modifying agents; ezetimibe

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2018-02-09

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET
EZETIMIBE 10 MG TABLETS
KEY PHARMACEUTICALS
LTD. PL 34424/0005
PA 0343/001/001
VERSION NO. – 08 (SEPTEMBER 2020)_MM
PAGE 1 OF 7
Package leaflet: Information for the user
EZETIMIBE 10 MG TABLETS
ezetimibe
Your medicine is called Ezetimibe 10 mg Tablets, but it will be
referred to as Ezetimibe
tablets or Ezetimibe throughout this leaflet.
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 side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT EZETIMIBE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EZETIMIBE TABLETS
3.
HOW TO TAKE EZETIMIBE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE EZETIMIBE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT EZETIMIBE TABLETS ARE AND WHAT THEY ARE USED FOR
Ezetimibe tablets are a medicine to lower increased levels of
cholesterol.
Ezetimibe tablets lowers levels of total cholesterol, "bad"
cholesterol (LDL cholesterol),
and fatty substances called triglycerides in the blood. In addition,
Ezetimibe tablets raise
levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of Ezetimibe tablets, works by
reducing the cholesterol
absorbed in your digestive tract.
Ezetimibe tablets add 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 arter

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
22 September 2020
CRN009VJ7
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of ezetimibe.
Each tablet contains less than 1 mmol (23mg) of sodium in the form of
croscarmellose sodium, sodium lauryl sulphate and
sodium stearyl fumerate, that is to say that each tablet is
essentially sodium free.
Excipient(s) with known effect
Each tablet contains 44.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off – white, capsule shaped, flat bevelled edged, uncoated
tablets debossed with ‘EZE’ on one side and plain on other
side, approximately 8.2mm in length and 4.1mm in width.
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).
Homozygous Sitosterolaemia (Phytosterolaemia)
Ezetimibe is indicated as adjunctive therapy to diet for use in
patients with homozygous f