Lipitor 40 mg chewable tablets

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

ATORVASTATIN CALCIUM

Disponible des:

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

Codi ATC:

C10AA05

Designació comuna internacional (DCI):

ATORVASTATIN CALCIUM 40 mg

formulario farmacéutico:

CHEWABLE TABLET

Composición:

ATORVASTATIN CALCIUM 40 mg

tipo de receta:

POM

Área terapéutica:

LIPID MODIFYING AGENTS

Estat d'Autorització:

Authorised

Data d'autorització:

2011-02-02

Informació per a l'usuari

Page 1 of 8
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPITOR 5 MG CHEWABLE TABLETS_ _
LIPITOR 10 MG CHEWABLE TABLETS
LIPITOR 20 MG CHEWABLE TABLETS
LIPITOR 40 MG CHEWABLE 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 the combinat

Fitxa tècnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 26
1.
NAME OF THE MEDICINAL PRODUCT
Lipitor 5 mg chewable tablets
Lipitor 10 mg chewable tablets
Lipitor 20 mg chewable tablets
Lipitor 40 mg chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 5 mg atorvastatin (as atorvastatin
calcium trihydrate).
Each chewable tablet contains 10 mg atorvastatin (as atorvastatin
calcium trihydrate).
Each chewable tablet contains 20 mg atorvastatin (as atorvastatin
calcium trihydrate).
Each chewable tablet contains 40 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect
Each Lipitor 5 mg chewable tablet contains 0.625 mg aspartame.
Each Lipitor 10 mg chewable tablet contains 1.25 mg aspartame.
Each Lipitor 20 mg chewable tablet contains 2.5 mg aspartame.
Each Lipitor 40 mg chewable tablet contains 5 mg aspartame.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
White to off-white, round chewable tablets with pink to purple specks,
debossed "5" on one
side and “LCT” on the other measuring 5.6 mm in diameter.
White to off-white, round chewable tablets with pink to purple specks,
debossed "10" on one
side and “LCT” on the other measuring 7.1 mm in diameter.
White to off-white, round chewable tablets with pink to purple specks
debossed "20" on one
side and "LCT" on the other measuring 8.7 mm in diameter.
White to off-white, round chewable tablets with pink to purple specks,
debossed "40" on one
side and "LCT" on the other measuring 10.3 mm in diameter.
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 Fredr