Atorvastatin ELC 10mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATORVASTATIN

Available from:

Basics GmbH Hemmelrather Weg 201 51377 Leverkusen, Germany

ATC code:

C10AA05

INN (International Name):

ATORVASTATIN 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ATORVASTATIN 10 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2011-10-11

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN ELC 10 MG FILM-COATED TABLETS
ATORVASTATIN ELC 20 MG FILM-COATED TABLETS
ATORVASTATIN ELC 40 MG FILM-COATED TABLETS
ATORVASTATIN ELC 80MG 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 ELC is and what it is used for
2.
What you need to know before you take Atorvastatin ELC
3.
How to take Atorvastatin ELC
4.
Possible side effects
5.
How to store Atorvastatin ELC
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN ELC IS AND WHAT IT IS USED FOR
Atorvastatin ELC belongs to a group of medicines known as statins,
which are lipid (fat) regulating
medicines.
Atorvastatin ELC 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 ELC 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 ELC
DO NOT TAKE ATORVASTATIN ELC:
•
if you are allergic to Atorvastatin ELC or to 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
contracep

Summary of Product characteristics

Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Atorvastatin ELC 10mg, 20mg, 40mg, 80mg Film-coated Tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg, 20mg, 40mg or 80mg atorvastatin (as
atorvastatin calcium
trihydrate).
Excipient with known effect:
10mg: Each tablet contains 33 mg lactose monohydrate and 0,86 mg
sodium.
20mg: Each tablet contains 66 mg lactose monohydrate and 1.73 mg
sodium.
40mg: Each tablet contains 131 mg lactose monohydrate and 3.45 mg
sodium.
80mg: Each tablet contains 262 mg lactose monohydrate and 6.9 mg
sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
10mg: White to off white, elliptical tablets about 5mm wide and 10mm
long marked “AS 10”
on one side and plain on the other side.
20mg: White to off white, elliptical, tablets about 6mm wide and 12 mm
long marked “AS 20”
on one side and plain on the other side.
40mg: White to off white, elliptical, tablets about 8mm wide and 15 mm
long marked “AS 40”
on one side and plain on the other side.
80mg ;White to off white, elliptical, tablets about 10mm long and 19
mm wide marked “AS
80” 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 wit
h pr
i
mary
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.
Page 2 of 24
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