Lipitor Tablets Chewable 40mg

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

ATORVASTATIN CALCIUM

Dostopno od:

Pfizer Hellas S.A.

Koda artikla:

C10AA05

INN (mednarodno ime):

ATORVASTATIN CALCIUM

Farmacevtska oblika:

CHEWABLE TABLET

Sestava:

ATORVASTATIN CALCIUM 40 milligram(s)

Tip zastaranja:

POM

Terapevtsko območje:

LIPID MODIFYING AGENTS

Status dovoljenje:

Authorised

Datum dovoljenje:

2011-02-02

Navodilo za uporabo

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PACKAGE LEAFLET
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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
−
if you are breast-feeding
−
if you use the combina

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS
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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
o