Atorvastatin 10 mg film-coated tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Atorvastatin-calcium

Dostupno od:

Accord Healthcare Ireland Ltd.

ATC koda:

C10AA; C10AA05

INN (International ime):

Atorvastatin-calcium

Doziranje:

10 milligram(s)

Farmaceutski oblik:

Film-coated tablet

Područje terapije:

HMG CoA reductase inhibitors; atorvastatin

Status autorizacije:

Marketed

Datum autorizacije:

2009-09-18

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN 10 MG, 20 MG, 40MG & 80MG 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 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 are breast-feeding
-
if you use the combination of glecaprevir/pibrentasvir in the
treatment of hepatitis C.
WARNINGS AND PRECAUTIONS
Ta

Svojstava lijeka

Health Products Regulatory Authority
11 March 2020
CRN009KGQ
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 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 4.9 mm film-coated tablets marked with “10”
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 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. Adjustment of dose should
be made at intervals of 4 weeks or more. The
maximum dose is 80 mg once a day.
_Primary hypercholesterola