Ezetimibe 10mg Tablets

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

EZETIMIBE

Dostupné z:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

ATC kód:

C10AX09

INN (Medzinárodný Name):

EZETIMIBE 10 mg

Forma lieku:

TABLET

Zloženie:

EZETIMIBE 10 mg

Typ predpisu:

POM

Terapeutické oblasti:

LIPID MODIFYING AGENTS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2014-01-23

Príbalový leták

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, this
medicine raises levels of "good"
cholesterol (HDL cholesterol).
Ezetimibe, the active substance of [Nationally completed name], 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" choles

Súhrn charakteristických

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 with known effect: 68 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to almost white, oval tablets (7.4 mm x 4.1 mm) with debossing
“10” on one side and “EZT” on
the other side.
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.
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 Ezetimibe
Route of administration is oral. The recommended dose is one Ezetimibe
10 mg tablet daily.
Ezetimibe can be administered at any time of the day,