ATORVASTATIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ATORVASTATIN CALCIUM

Available from:

WPR Healthcare Limited

ATC code:

C10AA05

INN (International Name):

ATORVASTATIN CALCIUM

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

atorvastatin

Authorization status:

Authorised

Authorization date:

2015-06-12

Patient Information leaflet

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
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Atorvastatin is and what it is used for
2.
Before you use Atorvastatin
3.
How to take Atorvastatin
4.
Possible side effects
5.
How to store Atorvastatin
6.
Further 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.
BEFORE YOU TAKE ATORVASTATIN
DO NOT TAKE ATORVASTATIN:

if you are hypersensitive (allergic) to atorvastatin or to any similar
medicines used to lower blood lipids or to any
of the other ingredients of the medicine – see Section 6 for
details.

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-feeding.
TAKE SPECIAL CARE WITH ATORVASTATIN
The following are reasons why A

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 of atorvastatin (as
atorvastatin calcium).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK:_
White to off-white, elliptic, biconvex and smooth film-coated tablets.
The dimensions of each tablet are approximately
9.7mm x 5.2mm.
4 CLINICAL PARTICULARS
As per PA0749/110/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0749/110/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core:
Microcrystalline cellulose
Sodium carbonate anhydrous
Maltose
Croscarmellose sodium
Magnesium stearate
Film-Coating:
Hypromellose (E464)
Hydroxypropylcellulose
Triethyl citrate (E1505)
Polysorbate 80
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack: 28 film-coated tablets in a cardboard box.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused product or waste material should be disposed of