Lipitor 20 mg chewable tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Atorvastatin

Доступно од:

Pfizer Ireland Pharmaceuticals

АТЦ код:

C10AA; C10AA05

INN (Међународно име):

Atorvastatin

Дозирање:

20 milligram(s)

Фармацеутски облик:

Chewable tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

HMG CoA reductase inhibitors; atorvastatin

Статус ауторизације:

Marketed

Датум одобрења:

2010-11-12

Информативни летак

Page 1 of 7
2019-0054511, 2019-0054859
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPITOR
 5MG, 10 MG, 20 MG AND 40 MG CHEWABLE 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 LIPITOR is and what it is used for
2.
What you need to know before you take LIPITOR
3.
How to take LIPITOR
4.
Possible side effects
5.
How to store LIPITOR
6.
Contents of the pack and other information
1.
WHAT LIPITOR IS AND WHAT IT IS USED FOR
Lipitor belongs to a group of medicines known as statins, which are
lipid (fat) regulating
medicines.
Lipitor 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, Lipitor 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 LIPITOR
DO NOT TAKE LIPITOR:

if you are allergic to atorvastatin or any of the other ingredients of
this 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
WARNI

Карактеристике производа

HealthProductsRegulatoryAuthority
26March2021
CRN009PFP
Page1of20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipitor20mgchewabletablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachchewabletabletcontains20
mgatorvastatin(asatorvastatincalciumtrihydrate).
Excipient(s) with known effect:
EachLipitor20
mgchewabletabletcontains2.5mgaspartame.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Chewabletablet
Whitetooff-white,roundchewabletabletswithpinktopurplespecks,debossed20ononesideandLCTontheother
measuring8.7mmindiameter. 
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Lipitor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.
Lipitor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 ME