Ezetimibe/ Atorvastatin Zentiva 10 mg/20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ezetimibe; Atorvastatin calcium trihydrate

Available from:

Zentiva k.s.

ATC code:

C10BA05

INN (International Name):

Ezetimibe; Atorvastatin calcium trihydrate

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

atorvastatin and ezetimibe

Authorization status:

Not marketed

Authorization date:

2024-02-23

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
11 March 2024
CRN00D5D5
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin/Ezetimibe 10 mg/20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg ezetimibe and 20 mg
atorvastatin (as atorvastatin calcium trihydrate).
Excipient(s) with known effect:
Each 10 mg/20 mg film-coated tablet contains 180.79 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, capsule shaped with the dimensions of
approximately 15 mm x 6 mm, biconvex, film-coated tablets with
one side debossed "2T and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Prevention of Cardiovascular Events_
Atorvastatin/Ezetimibe 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_
Atorvastatin/Ezetimibe 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)_
Atorvastatin/Ezetimibe 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
ezetimibe/atorvastatin.
The dose range of ezetimibe/atorvastatin is 10/10 mg/day through 10/80
mg/day. The typical dose is 10/10