Atorvastatin Liconsa 10 mg film-coated tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Atorvastatin calcium trihydrate

Verfügbar ab:

Laboratorios LICONSA, S.A.

ATC-Code:

C10AA05

INN (Internationale Bezeichnung):

Atorvastatin calcium trihydrate

Darreichungsform:

Film-coated tablet

Therapiebereich:

atorvastatin

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2022-10-28

Gebrauchsinformation

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN LICONSA 10 MG FILM-COATED TABLETS
ATORVASTATIN LICONSA 20 MG FILM-COATED TABLETS
ATORVASTATIN LICONSA 40 MG FILM-COATED TABLETS
ATORVASTATIN LICONSA 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 Liconsa is and what it is used for
2.
What you need to know before you take Atorvastatin Liconsa
3.
How to take Atorvastatin Liconsa
4.
Possible side effects
5.
How to store Atorvastatin Liconsa
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN LICONSA IS AND WHAT IT IS USED FOR
Atorvastatin Liconsa belongs to a group of medicines known as statins,
which are lipid (fat) regulating
medicines.
Atorvastatin Liconsa 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 Liconsa 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 LICONSA
DO NOT TAKE ATORVASTATIN LICONSA
− 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 abl

Fachinformation

Health Products Regulatory Authority
11 May 2023
CRN00DGF4
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Liconsa 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect:
Each film-coated tablet contains 48.23 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex film-coated tablets with bisection line on one
side and debossed 10 on other side. Diameter 7 mm ±
0.2 mm. The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin Liconsa 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 Liconsa 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 Liconsa and should
continue on this diet during treatment with Atorvastatin Liconsa.
The dose should be individual