Atorvastatin Pfizer 20 mg film coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atorvastatin calcium

Available from:

Pfizer Ireland Pharmaceuticals

ATC code:

C10AA; C10AA05

INN (International Name):

Atorvastatin calcium

Dosage:

20 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:

2011-10-28

Patient Information leaflet

Page 1 of 6
2018-0040731, 2018-0040732
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN PFIZER 10 MG FILM-COATED TABLETS
ATORVASTATIN PFIZER 20 MG FILM-COATED TABLETS
ATORVASTATIN PFIZER 40 MG FILM-COATED TABLETS
ATORVASTATIN PFIZER 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, 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 of the 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 Pfizer
is and what it is used for
2.
What you need to know before you take Atorvastatin Pfizer
3.
How to take Atorvastatin Pfizer
4.
Possible side effects
5.
How to store Atorvastatin Pfizer
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN PFIZER
IS AND WHAT IT IS USED FOR
Atorvastatin Pfizer
belongs to a group of medicines known as statins, which are lipid
(fat) regulating
medicines.
Atorvastatin Pfizer
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 Pfizer 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 PFIZER
DO NOT TAKE ATORVASTATIN PFIZER:

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 y

Summary of Product characteristics

Health Products Regulatory Authority
20 September 2019
CRN008PD1
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Pfizer 20 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect
Each Atorvastatin Pfizer 20 mg film-coated tablet contains 54.50 mg
lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White round, 7.1 mm, film-coated tablets debossed 20 on one side and
ATV on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin Pfizer 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 Pfizer 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 Pfizer and should continue
on this diet during treatment with Atorvastatin Pfizer. 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