Atorvastatin Centrient 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atorvastatin

Available from:

Centrient Pharmaceuticals Netherlands B.V

ATC code:

C10AA; C10AA05

INN (International Name):

Atorvastatin

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors; atorvastatin

Authorization status:

Not marketed

Authorization date:

2017-10-20

Patient Information leaflet

1
Classification: CONFIDENTIAL
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN CENTRIENT 10 MG FILM-COATED TABLETS
ATORVASTATIN CENTRIENT 20 MG FILM-COATED TABLETS
ATORVASTATIN CENTRIENT 30 MG FILM-COATED TABLETS
ATORVASTATIN CENTRIENT 40 MG FILM-COATED TABLETS
ATORVASTATIN CENTRIENT 60 MG FILM-COATED TABLETS
ATORVASTATIN CENTRIENT 80 MG FILM-COATED TABLETS
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 pharmacist or
nurse.

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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What
ATORVASTATIN CENTRIENT
is and what it is used for
2.
What you need to know before you take
ATORVASTATIN CENTRIENT
3.
How to take
ATORVASTATIN CENTRIENT
4.
Possible side effects
5.
How to store
ATORVASTATIN CENTRIENT
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN CENTRIENT IS AND WHAT IT IS USED FOR
ATORVASTATIN CENTRIENT
belongs to a group of medicines known as statins, which are lipid
(fat) regulating
medicines.
ATORVASTATIN CENTRIENT
is used to lower lipids known as cholesterol and triglycerides in the
blood when a
low fat diet and life style changes on their own have failed. If you
are at an increased risk of heart disease,
ATORVASTATIN CENTRIENT
can also be used to reduce such risk even if your cholesterol levels
are normal. You
should maintain a standard cholesterol lowering diet during treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN CENTRIENT
DO NOT TAKE ATORVASTATIN CENTRIENT

if you are allergic to atorvastatin
CENTRIENT
or any of the other ingredients of this medicine (listed in
section 6)

if you have o

Summary of Product characteristics

Health Products Regulatory Authority
21 January 2022
CRN00CKRX
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Centrient 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ATORVASTATIN CENTRIENT 20 mg film-coated tablets: Each film-coated
tablet contains 20 mg atorvastatin (as atorvastatin calcium
trihydrate).
Excipient(s) with known effect:
Each ATORVASTATIN CENTRIENT 20 mg film-coated tablet contains 107.60
mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
ATORVASTATIN CENTRIENT 20 mg film-coated tablets: white oblong
film-coated tablets, embossed 20 on one side and ‘ATV’ on
the other side and length: 10.6 mm; width: 5.3 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
ATORVASTATIN CENTRIENT is indicated as an adjunct to diet for
reduction of elevated total cholesterol (total-C), LDL-cholesterol
(LDL-C), apolipoprotein B, and triglycerides in adults, adolescents
and children aged 10 years or older with primary
hypercholesterolaemia including familial hypercholesterolaemia
(heterozygous variant) or combined (mixed) hyperlipidaemia
(Corresponding to Types IIa and IIb of the Fredrickson classification)
when response to diet and other nonpharmacological
measures is inadequate.
ATORVASTATIN CENTRIENT is also indicated to reduce total-C and LDL-C
in adults with homozygous familial
hypercholesterolaemia as an adjunct to other lipid-lowering treatments
(e.g. LDL apheresis) or if such treatments are
unavailable.
Prevention of cardiovascular disease
Prevention of cardiovascular events in adult patients estimated to
have a high risk for a first cardiovascular event (see section
5.1), as an adjunct to correction of other risk factors.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should be placed on a standard cholesterol-lowering diet
before receiving ATORVASTATIN CENTRIENT and should
continue on this diet during treatment with ATORVASTATIN CENTR