Atorvas 80 mg film-coated tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Atorvastatin calcium trihydrate

Dostupné s:

Rowex Ltd

ATC kód:

C10AA; C10AA05

INN (Mezinárodní Name):

Atorvastatin calcium trihydrate

Dávkování:

80 milligram(s)

Léková forma:

Film-coated tablet

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

HMG CoA reductase inhibitors; atorvastatin

Stav Autorizace:

Not marketed

Datum autorizace:

2010-09-03

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATORVAS 10 MG FILM-COATED TABLETS
ATORVAS 20 MG FILM-COATED TABLETS
ATORVAS 40 MG FILM-COATED TABLETS
ATORVAS 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 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 Atorvas is and what it is used for
2. What you need to know before you take Atorvas
3. How to take Atorvas
4. Possible side effects
5
How to store Atorvas
6. Contents of the pack and other information
1.
WHAT ATORVAS IS AND WHAT IT IS USED FOR
Atorvas belongs to a group of medicines known as statins, which are
lipid (fat) regulating medicines.
Atorvas is used to lower lipids known as cholesterol and triglycerides
in the blood when a low fat diet
and lifestyle changes on their own have failed. If you are at an
increased risk of heart disease, Atorvas
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 ATORVAS
DO NOT TAKE ATORVAS:
−
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

Charakteristika produktu

Health Products Regulatory Authority
02 January 2024
CRN00F15F
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvas 80 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablets contains 80 mg of atorvastatin (as
atorvastatin calcium trihydrate)
Excipient with known effect
Each film-coated tablet contains 207.1 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, round, biconvex film-coated tablet with debossment
"A80" on one side and cross scored breaking notch on
the other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Hypercholesterolaemia_
Atorvas 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.
Atorvas 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 Atorvas and should continue on this diet
during treatment with Atorvas.
The dose should be individualised according to baseline LDL-C levels,
the goal of therapy, and patient response.
The usual starting