Ezetimibe Tablets 10mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

EZETIMIBE

Available from:

Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic

ATC code:

C10AX09

INN (International Name):

EZETIMIBE 10 mg

Pharmaceutical form:

TABLET

Composition:

EZETIMIBE 10 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2016-12-15

Patient Information leaflet

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 is a medicine 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).
Ezetimibe, the active ingredient of Ezetimibe, works by reducing the
cholesterol absorbed in
your digestive tract.
Ezetimibe 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 chole

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ezetimibe 10 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipient(s) with known effect:
Each tablet contains 79.00 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White, oblong tablets with length approx. 8.10 mm and width approx.
4.10 mm, plain on both
sides.
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).
_ _
_Homozygous Sitosterolaemia (phytosterolaemia)_
Ezetimibe is indicated as adjunctive therapy to diet for use in
patients with homozygous
familial sitosterolaemia.
Ezetimibe
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The patient should be on an appropriate lipid
lowering diet and should continue on this diet
during treatment with Ezetimibe.
Posology
The recommended dose is one Ezetimibe 10 mg tablet daily.
When Ezetimibe is added to a statin, either the indicated usual
initial do