ATORVASTATIN 10 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ATORVASTATIN CALCIUM TRIHYDRATE

Available from:

Chanelle Medical

ATC code:

C10AA05

INN (International Name):

ATORVASTATIN CALCIUM TRIHYDRATE

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors

Authorization status:

Authorised

Authorization date:

2010-01-29

Patient Information leaflet

ID 140M/141M/142M/143M
VERSION: 10
EFFECTIVE DATE: 04/12/2017
PAGE 1 OF 6
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
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 is and what it is used for
2.
What you need to know before you take Atorvasatin
3.
How to take Atorvastatin
4.
Possible side effects
5.
How to store Atorvastatin
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN 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 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
DO NOT TAKE ATORVASTATIN:
−
if you are allergic to ATORVASTATIN or to any of the other ingredients
of the
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
contraceptio

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin
calcium trihydrate)
Excipients with known effect:
Each Atorvastatin 10 mg film-coated Tablet contains 33 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
White oval shaped film-coated tablet, plain on both sides.
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 (eg. 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 is 80 mg once a day.
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