Ezetrol 10 mg Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Ezetimibe

可用日期:

Imbat Limited

ATC代码:

C10AX; C10AX09

INN（国际名称）:

Ezetimibe

剂量:

10 milligram(s)

药物剂型:

Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Other lipid modifying agents; ezetimibe

授权状态:

Authorised

授权日期:

2016-10-21

资料单张

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETROL
® 10 MG TABLETS
ezetimibe
Your medicine is available using the above name but will be
referred to as Ezetrol throughout this leaflet.
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 strok

产品特点

Health Products Regulatory Authority
03 March 2020
CRN00957W
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 Czech Republic & UK_
White to off-white, capsule-shaped tablets debossed with '414' on one
side
4 CLINICAL PARTICULARS
As per PA0035/096/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0035/096/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Povidone
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
blister strip and outer carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30ºC.
Store in the original package in order to protect from moisture.
Health Products Regulatory Authority
03 March 2020
CRN00957W
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing PVC blisters
_Product imported from Czech Republic_
Pack size: 30 tablets
_Product imported from UK_
Pack size: 28 tablets
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 MARKETING AUTHORISATION NUMBER
PPA1151/256/001
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/256/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21
st
October 2016
10 DATE OF REVISION OF THE TEXT
March 2020