Atorvastatin 80 mg Film-Coated Tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Atorvastatin Calcium Trihydrate

Saatavilla:

Wockhardt UK Limited

ATC-koodi:

C10AA; C10AA05

INN (Kansainvälinen yleisnimi):

Atorvastatin Calcium Trihydrate

Annos:

80 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

HMG CoA reductase inhibitors; atorvastatin

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2012-06-22

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN 10 MG FILM-COATED TABLETS
ATORVASTATIN 20 MG FILM-COATED TABLETS
ATORVASTATIN 40 MG FILM-COATED TABLETS
ATORVASTATIN 80 MG FILM-COATED TABLETS
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 Tablets are and what they are used for
2. What you need to know before you take Atorvastatin Tablets
3. How to take Atorvastatin Tablets
4. Possible side effects
5. How to store Atorvastatin Tablets
6. Contents of the pack and other information
1. WHAT ATORVASTATIN TABLETS ARE AND WHAT THEY ARE 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 TABLETS
DO NOT TAKE ATORVASTATIN TABLETS
• 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 o

Valmisteyhteenveto

Health Products Regulatory Authority
07 August 2020
CRN009JF4
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin 80 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect: This medicinal product contains sodium
(as sodium lauryl sulfate, anhydrous sodium carbonate,
croscarmellose sodium) and mannitol (E421).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White coloured, oval shaped, biconvex tablets with one side embossed
“80” and other side plain.
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 startin