Atorvastatin Krka 40 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atorvastatin

Available from:

KRKA, d.d., Novo mesto

ATC code:

C10AA; C10AA05

INN (International Name):

Atorvastatin

Dosage:

40 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:

2010-07-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATORVASTATIN KRKA 10 MG FILM-COATED TABLETS
ATORVASTATIN KRKA 20 MG FILM-COATED TABLETS
ATORVASTATIN KRKA 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 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 Krka is and what it is used for
2.
What you need to know before you take Atorvastatin Krka
3.
How to take Atorvastatin Krka
4.
Possible side effects
5.
How to store Atorvastatin Krka
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN KRKA IS AND WHAT IT IS USED FOR
Atorvastatin Krka belongs to a group of medicines known as statins,
which are lipid (fat) regulating
medicines.
Atorvastatin Krka 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 Krka 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 KRKA
DO NOT TAKE ATORVASTATIN KRKA
-
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 or trying to become pregnant
-
if you are breast-

Summary of Product characteristics

Health Products Regulatory Authority
24 May 2023
CRN00DHJD
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin Krka 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg atorvastatin as atorvastatin calcium.
Excipient with known effect:
Each 40 mg film-coated tablet contains 216.20 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round (diameter = 10 mm), slightly convex, bevel-edged.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin Krka is indicated as an adjunct to diet for reduction of
elevated total cholesterol (totalC), 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 Krka 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 Krka and should continue
on this diet during treatment with Atorvastatin Krka.
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