EZETIMIBE APOTEX

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

EZETIMIBE

Disponibil de la:

Apotex Europe B.V.

Codul ATC:

C10AX09

INN (nume internaţional):

EZETIMIBE

Dozare:

10 Milligram

Forma farmaceutică:

Tablets

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

ezetimibe

Statutul autorizaţiei:

Authorised

Data de autorizare:

2017-12-15

Prospect

EZETIMIBE APOTEX 10 MG, TABLETS
MODULE 1.3
Product Information
Version: 2018-03-23
MODULE 1.3.1
Package Leaflet
Replaces : 2017-11-10
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
EZETIMIBE APOTEX 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 Apotex is and what it is used for
2.
What you need to know before you take Ezetimibe Apotex
3.
How to take Ezetimibe Apotex
4.
Possible side effects
5.
How to store Ezetimibe Apotex
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE APOTEX IS AND WHAT IT IS USED FOR
Ezetimibe Apotex 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 s

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe Apotex 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg Ezetimibe.
Excipient(s) with known effect:
Each tablet contains 86.5 mg of Lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white,
flat-face bevelled edge,
capsule shaped tablet (3.967 mm x 7.938 mm).
Engraved “APO” on one
side and “EZ 10” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_PRIMARY HYPERCHOLESTEROLAEMIA_
Ezetimibe Apotex, co-administered with an HMG-CoA reductase inhibitor
(statin) is indicated as adjunctive therapy to
diet for use in the patients with primary (heterozygous familial and
non-familial) hypercholesterolaemia who are not
appropriately controlled with a statin alone.
Ezetimibe Apotex 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 Apotex 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 Apotex 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 Apotex.
The recommended dose is one Ezetimibe Apotex 10 mg tablet daily.
When Ezetimibe Apotex is added to a statin, either the indicated usual
initial dose of that particular statin or the already
established higher statin dose sh