Ezetimibe Teva Tablets 10mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

EZETIMIBE

Available from:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

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Withdrawn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:

2016-05-04

Patient Information leaflet

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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Ezetimibe Teva 10 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipient with known effect:
Each tablet contains 35 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
8.2 mm x 4.1 mm white, biconvex, capsule shaped tablets, with debossed
“10” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia
Ezetimibe Teva, 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 Teva 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 Teva 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 Teva 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 recommended dose is one Ezetimibe Teva 10 mg tablet daily.
Ezetimibe Teva can be administered at
any time of the day, with or without food.
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When Ezetimibe Teva is added to a statin, either the indicated usual
initial dose of that particular statin or
the already established higher statin dose should be continued. In
this setting, the dosage instructions for that
particular statin should be consulted.
_USE IN PATIENTS WITH