EZEVAST 10 mg/ 10 mg, tabletten

국가: 네덜란드

언어: 네덜란드어

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

유효 성분:

ATORVASTATINE CALCIUM 3-WATER 10,9 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk

제공처:

Fidia Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A I-35031 ABANO TERME - PADOVA (ITALIË)

INN (국제 이름):

ATORVASTATINE CALCIUM 3-WATER 10,9 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk

약제 형태:

Tablet

구성:

CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201), CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201)

관리 경로:

Oraal gebruik

승인 날짜:

1900-01-01

환자 정보 전단

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PACKAGE LEAFLET: INFORMATION FOR THE USER
EZEVAST 10 MG/ 10 MG, TABLETTEN
EZEVAST 10 MG/ 20 MG, TABLETTEN
EZEVAST 10 MG/ 40 MG, TABLETTEN
EZEVAST 10 MG/ 80 MG, TABLETTEN
ezetimibe and atorvastatin
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 Ezevast is and what it is used for
2.
What you need to know before you take Ezevast
3.
How to take Ezevast
4.
Possible side effects
5.
How to store Ezevast
6.
Contents of the pack and other information
1.
WHAT EZEVAST IS AND WHAT IT IS USED FOR
Ezevast is a medicine to lower increased levels of cholesterol.
Ezevast contains ezetimibe and atorvastatin.
Ezevast is used in adults to lower levels of total cholesterol,
“bad” cholesterol (LDL cholesterol), and fatty
substances called triglycerides in the blood. In addition, Ezevast
raises levels of “good” cholesterol (HDL
cholesterol).
Ezevast works to reduce your cholesterol in two ways. It reduces the
cholesterol absorbed in your digestive
tract, as well as 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
atta

제품 특성 요약

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
EZEVAST 10 mg/ 10 mg, tabletten
EZEVAST 10 mg/ 20 mg, tabletten
EZEVAST 10 mg/ 40 mg, tabletten
EZEVAST 10 mg/ 80 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe and 10, 20, 40 or 80 mg of
atorvastatin (as atorvastatin calcium
trihydrate).
Excipients with known effect
Each 10 mg/10 mg tablet contains 145 mg lactose.
Each 10 mg/20 mg tablet contains 170 mg lactose.
Each 10 mg/40 mg tablet contains 219 mg lactose.
Each 10 mg/80 mg tablet contains 317 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
10 mg/10 mg tablet: White to off white, capsule-shaped tablets (12.7
mm × 5.1 mm) on one side debossed with
“1”
10 mg/20 mg tablet: White to off white, capsule-shaped tablets (14.5
mm × 6.8 mm) on one side debossed with
“2”
10 mg/40 mg tablet: White to off white, capsule-shaped tablets (16.4
mm × 6.3 mm) on one side debossed with
“3”
10 mg/80 mg tablet: White to off white, capsule-shaped tablets (17.0
mm × 8.0 mm) on one side debossed with
“4”
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ezevast as an adjunct to diet is indicated as substitution therapy for
treatment of adults with primary
(heterozygous and homozygous familial and non-familial)
hypercholesterolaemia or mixed hyperlipidaemia
already controlled with atorvastatin and ezetimibe given concurrently
at the same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Ezevast is 1 tablet per day.
The maximum recommended dose of Ezevast is 10 mg/80 mg per day.
The patient should be on an appropriate lipid lowering diet and should
continue on this diet during treatment
with Ezevast.
Ezevast is not suitable for initial therapy. Treatment initiation or
dose adjustment if necessary should only be
done with the monocomponents and after setting the appropriate doses
the switch to the fixed dose combination
of the appropriate st