Ezetimibe 10 mg tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Ezetimibe

Disponible desde:

Glenmark Pharmaceuticals Europe Limited

Código ATC:

C10AX; C10AX09

Designación común internacional (DCI):

Ezetimibe

Dosis:

10 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Other lipid modifying agents; ezetimibe

Estado de Autorización:

Authorised

Fecha de autorización:

2015-07-10

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE 10 MG TABLETS
Ezetimibe
SAME SIZE ARTWORK
LEAFLET SIZE: 120 mm x 460 mm
DATE: 03-11-2017
VERSION: 08 (UK)
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
tablets,
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

Ficha técnica

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(s) with known effect:
Each tablet contains 69.75 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, capsule shaped, approximately 8.0 x 4.0 x 2.6 mm
in size, flat, bevelled edged uncoated tablets
engraved with ‘G’ on one side and “44” 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 nonfamilial)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
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 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 particul