Atorvastatin 20 mg film-coated tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Atorvastatin-calcium

Beschikbaar vanaf:

Actavis Group PTC ehf

ATC-code:

C10AA; C10AA05

INN (Algemene Internationale Benaming):

Atorvastatin-calcium

Dosering:

20 milligram(s)

farmaceutische vorm:

Film-coated tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

HMG CoA reductase inhibitors; atorvastatin

Autorisatie-status:

Marketed

Autorisatie datum:

2009-09-18

Bijsluiter

ATORVASTATIN 10 MG, 20 MG, 40 MG & 80 MG
FILM-COATED TABLETS
Atorvastatin
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 IS AND WHAT
IT IS USED FOR
2
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ATORVASTATIN
3
HOW TO TAKE ATORVASTATIN
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ATORVASTATIN
6
CONTENTS OF THE PACK AND
OTHER INFORMATION
1
WHAT ATORVASTATIN IS AND WHAT
IT IS USED FOR
Atorvastatin belongs to a group of
medicines known as statins, which are
lipid (fat) regulating medicines.
Atorvastatin 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 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
DO NOT TAKE ATORVASTATIN:
•
if you are allergic to Atorvastatin
or any of the other ingredients of
medicine (listed in section 6)
•
if you have or have ever had a disease
which affects the liver
•
if you have had any unexplained
abnormal blood tests for liver function
•
if you are a woman able to have
children and not using reliable
contraception
•
if you are pregnant or trying to
become pregnant
•
if you are breast-feeding
•
if you use the combination of
glecaprevir/pibrentasvir in the
treatment of hepatitis C.
WARNINGS AND PRE

Productkenmerken

HealthProductsRegulatoryAuthority
26September2019
CRN0091QN
Page1of18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin20mgfilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachfilm-coatedtabletcontains20
mgofatorvastatinasatorvastatincalciumtrihydrate.
For thefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Film-coatedtablet.
White,oval,biconvex6.2x11.5mm
film-coatedtabletsmarkedwith“20”ononesideand“A”ontheother.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin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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r