Ezetrol 10 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ezetimibe

Available from:

PCO Manufacturing Ltd.

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:

Authorised

Authorization date:

2009-07-31

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETROL
®
10MG 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 EZETROL is and what it is used for
2.
What you need to know before you take EZETROL
3.
How to take EZETROL
4.
Possible side effects
5.
How to store EZETROL
6.
Contents of the pack and other information
1.
WHAT EZETROL IS AND WHAT IT IS USED FOR
EZETROL is a medicine to lower increased levels of cholesterol.
EZETROL lowers levels of total cholesterol, “bad” cholesterol (LDL
cholesterol), and fatty substances called triglycerides in the blood.
In addition, EZETROL raises levels of “good” cholesterol (HDL
cholesterol).
Ezetimibe, the active ingredient of EZETROL, works by reducing the
cholesterol absorbed in your digestive tract.
EZETROL 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 bad cholestero

Summary of Product characteristics

Health Products Regulatory Authority
15 July 2022
CRN00D0VQ
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetrol 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipient(s) with known effect:
Each tablet contains lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Greece, the Czech Republic and Poland:_
White to off-white, capsule-shaped tablets debossed with '414' on one
side.
4 CLINICAL PARTICULARS
As per PA23198/023/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/023/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Povidone (K29-32)
Sodium laurilsulfate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Health Products Regulatory Authority
15 July 2022
CRN00D0VQ
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
2 x blister strips containing 14 tablets contained in a carton or an
over-labelled outer carton.
Pack size: 28 tablets (sourced from the UK, Greece, Czech Republic &
Poland)
3 x blister strips containing 10 tablets or 2 x blisters containing 15
tablets contained in a carton and an over-labelled carton.
Pack size: 30 tablets (sourced from Greece & The Czech Republic).
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/227/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 31
st
July 2009
10 DATE OF REVISIO