Atorvastatin 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atorvastatin-calcium

Available from:

Actavis Group PTC ehf

ATC code:

C10AA; C10AA05

INN (International Name):

Atorvastatin-calcium

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors; atorvastatin

Authorization status:

Marketed

Authorization date:

2009-09-18

Patient Information leaflet

ATORVASTATIN 10 MG, 20 MG, 40 MG & 80 MG
FILM-COATED TABLETS
Atorvastatin
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
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 PRE

Summary of Product characteristics

Health Products Regulatory Authority
26 September 2019
CRN0091QN
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 hypercholeste