Lipitor 80 mg film-coated tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Atorvastatin

Доступно од:

PCO Manufacturing Ltd.

АТЦ код:

C10AA; C10AA05

INN (Међународно име):

Atorvastatin

Дозирање:

80 milligram(s)

Фармацеутски облик:

Film-coated tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

HMG CoA reductase inhibitors; atorvastatin

Статус ауторизације:

Authorised

Датум одобрења:

2005-07-29

Информативни летак

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

Карактеристике производа

Health Products Regulatory Authority
15 July 2022
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipitor 80 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect:
Each Lipitor 80 mg film-coated tablet contains lactose monohydrate and
benzoic acid.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Italy Spain, Poland and Czech Republic_
White elliptical tablet debossed '80' on one side and 'PD 158' on the
other side OR white and round with '80' on one side and
'ATV' on the other.
4 CLINICAL PARTICULARS
As per PA23055/017/004
5 PHARMACOLOGICAL PROPERTIES
As per PA23055/017/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core:
Calcium carbonate,
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Polysorbate 80
Hyprolose
Magnesium stearate
Film coat:
Film coating containing:
Hypromellose
Macrogol 8000
Titanium dioxide (E171)
Talc
Simethicone emulsion containing:
Simethicone
Stearate emulsifiers (polyethylene glycol sorbitan tristearate,
polyethoxylate stearate, glycerides)
Thickeners (methylcellulose, xanthan gum)
Benzoic acid (E 210)
Sorbic acid
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15 July 2022
CRN00D0NZ
Page 2 of 2
Sulfuric acid
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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
precautions.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack of 28 and 30 tablets contained in an outer cardboard
carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Irela