Atorvastatin 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atorvastatin calcium trihydrate

Available from:

Dexcel Pharma GmbH

ATC code:

C10AA; C10AA05

INN (International Name):

Atorvastatin calcium trihydrate

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:

Not marketed

Authorization date:

2011-12-05

Patient Information leaflet

Atorvastatin Tablets
1.3: Product information
1.3.1 Package leaflet
Page 1 of 7
[LOGO: DEXCEL® PHARMA GMBH]
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
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 Tablets belong to a group of medicines known as statins,
which are lipid (fat)
regulating medicines.
Atorvastatin Tablets are 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 Tablets
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
fun

Summary of Product characteristics

Health Products Regulatory Authority
09 May 2023
CRN00DGRP
Page 1 of 19
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).
Excipient with known effect:
Each film-coated tablet contains approximately 26 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round, film coated tablet, embossed “10” on one side.
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