Atorvastatin Basics 30 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATORVASTATIN CALCIUM, TRIHYDRATE

Available from:

Basics GmbH Hemmelrather Weg 201 51377 Leverkusen, Germany

ATC code:

C10AA05

INN (International Name):

ATORVASTATIN CALCIUM TRIHYDRATE 30 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ATORVASTATIN CALCIUM TRIHYDRATE 30 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2015-03-18

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN BASICS 30 MG FILM-COATED TABLETS
ATORVASTATIN BASICS 60 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 Basics is and what it is used for
2.
What you need to know before you take Atorvastatin Basics
3.
How to take Atorvastatin Basics
4.
Possible side effects
5.
How to store Atorvastatin Basics
6.
Contents of the pack and other information.
1.
WHAT ATORVASTATIN BASICS IS AND WHAT IT IS USED FOR
Atorvastatin Basics belongs to a group of medicines known as statins,
which are lipid (fat) regulating
medicines.
Atorvastatin Basics 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 Basics 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 BASICS
DO NOT TAKE ATORVASTATIN BASICS:
•
if you are allergic to atorvastatin or to any similar medicines used
to lower blood lipids 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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Atorvastatin Basics 30 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30mg atorvastatin (as atorvastatin calcium
trihydrate).
Excipient:
Each tablet contains 98.46 mg lactose monohydrate
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, elliptical tablets debossed ‘AS 30’ on one
side and plain on the other 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 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.
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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.
_Primary hypercholesterolaemia a