Ezetimibe Teva 10 mg tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Ezetimibe

Dostępny od:

Teva B.V.

Kod ATC:

C10AX; C10AX09

INN (International Nazwa):

Ezetimibe

Dawkowanie:

10 milligram(s)

Forma farmaceutyczna:

Tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Other lipid modifying agents; ezetimibe

Status autoryzacji:

Marketed

Data autoryzacji:

2016-06-03

Ulotka dla pacjenta

EZETIMIBE TEVA
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.
1.
What Ezetimibe Teva is and what it is
used for
2.
What you need to know before you
take Ezetimibe Teva
3.
How to take Ezetimibe Teva
4.
Possible side effects
5.
How to store Ezetimibe Teva
6.
Contents of the pack and other
information
WHAT EZETIMIBE TEVA IS AND WHAT
IT IS USED FOR
Ezetimibe Teva is a medicine to lower
increased levels of cholesterol
Ezetimibe Teva lowers levels of total
cholesterol, "bad" cholesterol (LDL
cholesterol), and fatty substances called
triglycerides in the blood. In addition,
Ezetimibe Teva raises levels of "good"
cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of
Ezetimibe Teva works by reducing the
cholesterol absorbed in your digestive
tract.
Ezetimibe Teva 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
arter

Charakterystyka produktu

Health Products Regulatory Authority
09 May 2022
CRN00CW0S
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe Teva 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe.
Excipient with known effect:
Each tablet contains 35 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
8.2 mm x 4.1 mm white, biconvex, capsule shaped tablets, with debossed
“10” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia
Ezetimibe Teva, 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 Teva 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 Teva 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 Teva 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 recommended dose is one Ezetimibe Teva 10 mg tablet daily.
Ezetimibe Teva can be administered at any time of the day,
with or without food.
When Ezetimibe Teva is added to a statin, either the indicated usual
initial dose of that particular statin or the already
established higher statin dose should be continued. In this setting,
the dosage instructions for that parti