Atozet 10mg/20mg film-coated tablets

Šalis: Malaizija

kalba: anglų

Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Veiklioji medžiaga:

EZETIMIBE; ATORVASTATIN CALCIUM TRIHYDRATE

Prieinama:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Tarptautinis Pavadinimas):

EZETIMIBE; ATORVASTATIN CALCIUM TRIHYDRATE

Vienetai pakuotėje:

30tablet Tablets; 10tablet Tablets

Pagaminta:

MSD International GmbH (Puerto Rico Branch) LLC

Pakuotės lapelis

_Consumer Medication Information Leaflet (RiMUP)_
ATOZET
® FILM-COATED TABLETS
_ _
Ezetimibe/atorvastatin
10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg
1
WHAT IS IN THIS LEAFLET
1.
What ATOZET tablet is used for
2.
How ATOZET tablet works
3.
Before you take ATOZET tablet
4.
How to use ATOZET tablet
5.
While you are taking ATOZET
tablet
6.
Side effects
7.
Storage and Disposal of
ATOZET tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT ATOZET TABLET IS USED FOR
Your doctor has prescribed ATOZET
tablet to reduce the amount of
cholesterol and triglycerides 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.
If you have heart disease, ATOZET
reduces the risk of heart attack,
stroke, surgery to increase heart
blood flow, or hospitalization for
chest pain.
HOW ATOZET TABLET WORKS
High cholesterol can be treated in
two main ways:
LIFESTYLE CHANGES
– including a
cholesterol-lowering diet, increased
physical activity, and weight
management.
MEDICATION
– Cholesterol-lowering
medicines are used together with
lifestyle changes to help lower
cholesterol. Your doctor has
prescribed ATOZET to help lower
your cholesterol.
BEFORE YOU TAKE ATOZET TABLET
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ATOZET TABLET IF
YOU:
•
are hypersensitive (allergic)

Prekės savybės

ATOZET
® (ezetimibe/atorvastatin) LPC-MK0653C-T-122018
[Tablet]
1. NAME OF THE DRUG
ATOZET ®10MG/10MG FILM-COATED TABLETS
(EZETIMIBE 10 MG/ATORVASTATIN 10 MG)
ATOZET ®10MG/20MG FILM-COATED TABLETS
(EZETIMIBE 10 MG/ATORVASTATIN 20 MG)
ATOZET ®10MG/40MG FILM-COATED TABLETS
(EZETIMIBE 10 MG/ATORVASTATIN 40 MG)
ATOZET ®10MG/80MG FILM-COATED TABLETS
(EZETIMIBE 10 MG/ATORVASTATIN 80 MG)
2. PHARMACEUTICAL FORM
Film-coated tablets
3. PHARMACEUTICAL PARTICULARS
3.1 Chemistry
ATOZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol
absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase
inhibitor.
Ezetimibe
The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-
4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C
24H21F2NO 3. Its molecular weight is
409.4.
Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and
acetone and practically insoluble in water. Its structural formula is: