EZETROL 10mg Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

EZETIMIBE

Available from:

Merck Sharp and Dohme Limited

ATC code:

C10AX09

INN (International Name):

EZETIMIBE

Dosage:

10mg Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other lipid modifying agents

Authorization status:

Transfer Pending

Authorization date:

2013-06-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETROL
® 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 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 the bad cholesterol from
building up in the arte

Summary of Product characteristics

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 55 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, capsule-shaped tablets, approximately 2.60 mm
thick, debossed with “414” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia
Ezetrol 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.
Ezetrol 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_
Ezetrol 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)
Ezetrol 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).
Homozygous Sitosterolaemia (Phytosterolaemia)
Ezetrol is indicated as adjunctive therapy to diet for use in patients
with homozygous familial sitosterolaemia.
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
Ezetrol.
Route of administration is oral.
The recommended dose is one Ezetrol 10 mg tablet daily.
Ezetrol can be administered
at any time of the day, with or without food.
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