Ezetimibe 10 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ezetimibe

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

C10AX; C10AX09

INN (International Name):

Ezetimibe

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other lipid modifying agents; ezetimibe

Authorization status:

Marketed

Authorization date:

2014-07-25

Patient Information leaflet

1
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 contains the active substance ezetimibe. Ezetimibe is a
medicine used 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).
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 arteries and protects against heart disease.
Triglycerides are another form of fat in your blood that may increase
your risk for heart disease.
Ezetimibe works by reducing the cholesterol absorbed in your digestive
tract. Ezetimibe does not help you
lose weight.
Ezetimibe adds to the cholesterol-lowering effect of statin

Summary of Product characteristics

Health Products Regulatory Authority
22 October 2021
CRN00CK9J
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe.
Excipient(s) with known effect: Lactose monohydrate.
Each tablet contains 62 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off white capsule shaped, bevelled edge tablet debossed with
‘M’ on one side of the tablet and ‘EE1’ on the other side,
approximately 8.2 mm in length and 4.1 mm 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).
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.
The recommended dose is one Ezetimibe 10 mg tablet daily.
When Ezetimibe is added to a statin, either the indicated usual
initial dose of that partic