Atorvastatin 20 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Atorvastatin calcium trihydrate

Disponibil de la:

Sun Pharmaceutical Industries Europe B.V.

Codul ATC:

C10AA; C10AA05

INN (nume internaţional):

Atorvastatin calcium trihydrate

Dozare:

20 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

HMG CoA reductase inhibitors; atorvastatin

Statutul autorizaţiei:

Marketed

Data de autorizare:

2012-09-07

Prospect

V036
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATORVASTATIN 10 MG FILM-COATED TABLETS
ATORVASTATIN 20 MG FILM-COATED TABLETS
ATORVASTATIN 40 MG FILM-COATED TABLETS
ATORVASTATIN 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 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
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

Caracteristicilor produsului

Health Products Regulatory Authority
05 December 2023
CRN00DW6Q
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 20mg of atorvastatin as atorvastatin
calcium trihydrate.
_ _
Excipient with known effect:
Contains 76.7 mg lactose monohydrate, 5.6 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, film-coated oval tablets about 6.6 mm wide and
about 12.1 mm long, embossed with 'A31' on one side and
plain on other side
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 receiving atorvastatin and should continue on this
diet during treatment with atorvastatin.
The dose should be individualised according to baseline LDL-C levels,
the goal of therapy, and patient response.
The usual starting dose is 10 mg once a day. Adju