Ezetimibe STADA 10 mg, tabletten

Država: Nizozemska

Jezik: nizozemski

Izvor: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivni sastojci:

EZETIMIB

Dostupno od:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC koda:

C10AX09

INN (International ime):

EZETIMIB

Farmaceutski oblik:

Tablet

Sastav:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON (E 1201),

Administracija rute:

Oraal gebruik

Područje terapije:

Ezetimibe

Proizvod sažetak:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POVIDON (E 1201);

Datum autorizacije:

2016-10-10

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE STADA 10MG, TABLETTEN
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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
is a medicine to lower increased levels of cholesterol
in your blood.
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 arteries and protects against heart disease.
Triglycerides are another form of fat in your blood that may increase
your risk for heart
disease.
lowers levels of total cholesterol, "bad" cholesterol
(LDL cholesterol), and
fatty substances called triglycerides in the blood. In addition,
raises levels
of "good" cholesterol (HDL cholesterol).
Ezetimibe, the ac

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ezetimibe STADA 10 mg, tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipients with known effect:
Each tablet contains 58 mg of lactose monohydrate and 0.80 mg of
sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White to off-white, oval, capsule-shaped tablets with a length of
approximately 8 mm and a
width of approximately 4 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary hypercholesterolaemia
, 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.
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
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)
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)

is
indicated
as
adjunctive
therapy
to
diet
for
use
in
patients
with
homozygous familial sitosterolaemia.
2
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.
The recommended dose is one ezetimibe 10 mg tablet daily. Ezetimibe
can be admini