Atorvastatin Teva 80 mg Film-coated Tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Atorvastatin

Saatavilla:

Teva Pharma B.V.

ATC-koodi:

C10AA; C10AA05

INN (Kansainvälinen yleisnimi):

Atorvastatin

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:

2010-10-08

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN TEVA 10 MG FILM-COATED TABLETS
ATORVASTATIN TEVA 20 MG FILM-COATED TABLETS
ATORVASTATIN TEVA 40 MG FILM-COATED TABLETS
ATORVASTATIN TEVA 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 Atorvastatin Teva is and what it is used for
2.
What you need to know before you take Atorvastatin Teva
3.
How to take Atorvastatin Teva
4.
Possible side effects
5.
How to store Atorvastatin Teva
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN TEVA 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 lifestyle 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 TEVA
DO NOT TAKE ATORVASTATIN TEVA
•
If you are allergic to atorvastatin or to any similar medicines used
to lower blood lipids or to
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

Valmisteyhteenveto

Health Products Regulatory Authority
03 July 2023
CRN00DJ66
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Teva 80 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 80 mg atorvastatin (as atorvastatin
calcium).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Atorvastatin Teva 80 mg Film-coated Tablets are white to off-white,
elliptic, biconvex and smooth film-coated tablets. The
dimensions of each tablet are approximately 18.8 mm x 10.3 mm.
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
Atorvastatin is indicated in 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
b