ATOZET 10 /10 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

EZETIMIBE, MICRONIZED, ATORVASTATIN, ATORVASTATIN CALCIUM TRIHYDRATE

Available from:

Merck Sharp and Dohme Limited

ATC code:

C10BA05

INN (International Name):

EZETIMIBE, MICRONIZED, ATORVASTATIN, ATORVASTATIN CALCIUM TRIHYDRATE

Dosage:

10 /10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors in combination with other lipid modifying agents

Authorization status:

Transfer Pending

Authorization date:

2014-11-07

Patient Information leaflet

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 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

Summary of Product characteristics

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 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
Capsule-shaped, biconvex, white to off-white, film-coated tablets,
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
cholesterol-lowering therapy should be considered when starting
therapy or adjusting the dose.
The dose of ATOZET should