Atozet 10 mg/80 mg film-coated tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Ezetimibe; Atorvastatin

Disponible depuis:

PCO Manufacturing Ltd.

Code ATC:

C10BA; C10BA05

DCI (Dénomination commune internationale):

Ezetimibe; Atorvastatin

Dosage:

10/80 mg/mg

forme pharmaceutique:

Film-coated tablet

Domaine thérapeutique:

HMG CoA reductase inhibitors in combination with other lipid modifying agents; atorvastatin and ezetimibe

Date de l'autorisation:

2021-06-25

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATOZET
® 10 MG/10 MG FILM-COATED TABLETS
ATOZET
® 10 MG/20 MG FILM-COATED TABLETS
ATOZET
®
10 MG/40 MG FILM-COATED TABLETS
ATOZET
®
10 MG/80 MG FILM-COATED TABLETS
EZETIMIBE/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 ATOZET is and what it is used for
2. What you need to know before you take ATOZET
3. How to take ATOZET
4. Possible side effects
5. How to store ATOZET
6. Contents of the pack and other information
1.
WHAT ATOZET IS AND WHAT IT IS USED FOR
ATOZET is a medicine to lower increased levels of cholesterol. ATOZET
contains
ezetimibe and atorvastatin.
ATOZET is used in adults to lower levels of total cholesterol,
“bad” cholesterol (LDL
cholesterol), and fatty substances called triglycerides in the blood.
In addition, ATOZET
raises levels of “good” cholesterol (HDL cholesterol).
ATOZET 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 attack

Résumé des caractéristiques du produit

Health Products Regulatory Authority
04 October 2023
CRN00DV1D
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atozet 10 mg/80 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of ezetimibe and 80 mg of
atorvastatin (as atorvastatin calcium trihydrate).
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Product imported from France:_
Film-coated tablet.
Capsule-shaped, biconvex, white to off-white, film-coated, size 19.05
mm x 7.94 mm, "357" debossed on one side.
4 CLINICAL PARTICULARS
As per PA23198/022/004
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/022/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core
Ezetimibe Layer
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Cellulose, microcrystalline
Povidone
Sodium laurilsulfate
Atorvastatin Layer
Cellulose, microcrystalline
Lactose monohydrate
Hydroxypropylcellulose
Croscarmellose sodium
Polysorbate 80
Calcium carbonate
Magnesium stearate
Silica, colloidal anhydrous
Film coating
Hypromellose
Macrogol 8000
Titanium dioxide (E171)
Talc
Health Products Regulatory Authority
04 October 2023
CRN00DV1D
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from oxygen.
6.5 NATURE AND CONTENTS OF CONTAINER
Packs of 30 film-coated tablets in aluminium blisters.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/470/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
June 2021
10 DATE OF REVISION OF THE TEXT
October