Lipitor 10mg film-coated tablets

Negara: Malta

Bahasa: Inggris

Sumber: Malta Medicines Authority

Bahan aktif:

ATORVASTATIN

Tersedia dari:

Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece

Kode ATC:

C10AA05

INN (Nama Internasional):

ATORVASTATIN 10 mg

Bentuk farmasi:

FILM-COATED TABLET

Komposisi:

ATORVASTATIN 10 mg

Jenis Resep:

POM

Area terapi:

LIPID MODIFYING AGENTS

Status otorisasi:

Authorised

Tanggal Otorisasi:

2005-10-05

Selebaran informasi

Page 1 of 8
PACKAGE LEAFLET
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
Page 2 of 8
−
if you are breast-feeding
−
if you use th

Karakteristik produk

Page 1 of 25
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lipitor 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect
Each Lipitor 10 mg film-coated tablet contains 27.25 mg lactose
monohydrate and 0.00004 mg
benzoic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White round, 5.6 mm, film-coated tablets debossed "10" on one side and
"ATV" on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Lipitor 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.
Lipitor 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 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.
Page 2 of 25
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should be placed on a standard cholesterol-lowering diet
before receiving Lipitor and
should continue on this diet during treatment with Lipitor.
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 do