Atozet 10mg/10mg Film-coated tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Ezetimibe; Atorvastatin

Dostopno od:

Merck Sharp & Dohme Ireland (Human Health) Limited

Koda artikla:

C10BA; C10BA05

INN (mednarodno ime):

Ezetimibe; Atorvastatin

Odmerek:

10 mg/10 milligram(s)

Farmacevtska oblika:

Film-coated tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

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

Status dovoljenje:

Marketed

Datum dovoljenje:

2014-11-07

Navodilo za uporabo

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 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 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 ATOZETATOZET 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 att

Lastnosti izdelka

Health Products Regulatory Authority
23 September 2020
CRN009NVD
Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atozet 10mg/10mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of ezetimibe and 10 mg of
atorvastatin (as atorvastatin calcium trihydrate).
Excipient(s) with known effect:
Each 10 mg/10 mg film-coated tablet contains 153 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
10 mg/10 mg tablet: Capsule-shaped, biconvex, white to off-white,
film-coated, size 12.74 mm x 5.10 mm, "257" debossed on
one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Prevention of Cardiovascular Events_
ATOZET 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), either previously
treated with a statin or not.
_Hypercholesterolaemia _
ATOZET is indicated as adjunctive therapy to diet for use in adults
with primary (heterozygous familial and non-familial)
hypercholesterolaemia or mixed hyperlipidaemia where use of a
combination product is appropriate.

patients not appropriately controlled with a statin alone

patients already treated with a statin and ezetimibe
_Homozygous Familial Hypercholesterolaemia (HoFH)_
ATOZET is indicated as adjunctive therapy to diet for use in adults
with HoFH. Patients may also receive adjunctive treatments
(e.g., low-density lipoprotein [LDL] apheresis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Hypercholesterolaemia and/or Coronary Heart Disease (with ACS
History)_
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during treatment with ATOZET.
The dose range of ATOZET is 10/10 mg/day through 10/80 mg/day. The
typical dose is 10/10 mg once a day. The patient's
low-density lipoprotein cholesterol (LDL‑C) level, coronary heart
disease risk status, and response to current
cholest