LIPITOR 10 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Viatris Healthcare (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS ATORVASTATIN CALCIUM EQUVALENT TO 10,0 mg ATORVASTATIN

Authorization status:

Registered

Authorization date:

1998-11-07

Patient Information leaflet

Viatris Healthcare (Pty) Ltd
Page 1 of 9
Lipitor 10, 20, 40, 80 tablet
Final approved PIL – 13 March 2023
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
LIPITOR
®
10 TABLET
LIPITOR
® 20 TABLET
LIPITOR
® 40 TABLET
LIPITOR
® 80 TABLET
ATORVASTATIN CALCIUM
READ THIS LEAFLET CAREFULLY BEFORE YOU START USING LIPITOR
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist.
•
LIPITOR has been prescribed for you personally and you should not
share it with other people. It may
harm them, even if their symptoms are the same as yours.
WHAT LIPITOR CONTAINS:
Each
LIPITOR
tablet
contains
the
active
ingredient
atorvastatin
calcium
trihydrate,
equivalent
to
10/20/40/80 mg atorvastatin respectively.
LIPITOR tablets contain the following inactive ingredients: Calcium
carbonate, microcrystalline cellulose,
lactose monohydrate, croscarmellose sodium, polysorbate 80,
hydroxypropyl cellulose and magnesium
stearate.
The coating of LIPITOR tablets contains Opadry white (consisting of
hydroxypropyl methylcellulose,
polyethylene glycol, titanium dioxide and talc) and simethicone
emulsion (consisting of simethicone,
stearate emulsifiers, thickeners, benzoic acid and sorbic acid). The
10, 20 and 40 mg tablets also contain
candelilla wax.
WHAT LIPITOR IS USED FOR:
Viatris Healthcare (Pty) Ltd
Page 2 of 9
Lipitor 10, 20, 40, 80 tablet
Final approved PIL – 13 March 2023
LIPITOR belongs to a group of medicines known as lipid or cholesterol
(fat) regulating medicines
commonly known as statins.
LIPITOR lowers cholesterol in your blood. It lowers the LDL-C ("bad"
cholesterol) and triglycerides in your
blood. It can raise your HDL-C ("good" cholesterol) as well. LIPITOR
is for adults and children over 10 whose
cholesterol does not come down enough with exercise and a low-fat diet
alone.
LIPITOR can lower risk of heart disease and disorders of the blood
vessels of the brain, which are
conditions due to reduced blood

Summary of Product characteristics

Viatris Healthcare (Pty) Ltd
Page 1 of 17
Lipitor 10, 20, 40, 80 tablet
Final approved PI – 13 March 2023
SCHEDULING STATUS: S4
PROPRIETARY NAME AND DOSAGE FORM:
LIPITOR
® 10 TABLET
LIPITOR
® 20 TABLET
LIPITOR
® 40 TABLET
LIPITOR
® 80 TABLET
COMPOSITION:
LIPITOR 10: Each tablet contains atorvastatin calcium trihydrate,
equivalent to 10 mg atorvastatin.
LIPITOR 20: Each tablet contains atorvastatin calcium trihydrate,
equivalent to 20 mg atorvastatin.
LIPITOR 40: Each tablet contains atorvastatin calcium trihydrate,
equivalent to 40 mg atorvastatin.
LIPITOR 80: Each tablet contains atorvastatin calcium trihydrate,
equivalent to 80 mg atorvastatin.
LIPITOR
tablets
contain
the
following
inactive
ingredients:
Calcium
carbonate,
microcrystalline
cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80,
hydroxypropyl cellulose and
magnesium stearate.
The coating of LIPITOR tablets contains Opadry white (consisting of
hydroxypropyl methylcellulose,
polyethylene glycol, titanium dioxide and talc) and simethicone
emulsion (consisting of simethicone,
stearate emulsifiers, thickeners, benzoic acid and sorbic acid). The
10, 20 and 40 mg tablets also
contain candelilla wax.
PHARMACOLOGICAL CLASSIFICATION:
A 7.5 Serum-cholesterol reducers
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
Atorvastatin is a selective, competitive inhibitor of HMG-CoA
reductase, the rate-limiting enzyme that
converts 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a
precursor of sterols, including
cholesterol.
Viatris Healthcare (Pty) Ltd
Page 2 of 17
Lipitor 10, 20, 40, 80 tablet
Final approved PI – 13 March 2023
The liver is its primary site of action and the principal site of
cholesterol synthesis and low-density
lipoprotein cholesterol (LDL-C) clearance.
In animal models, atorvastatin lowers plasma cholesterol and
lipoprotein levels by inhibiting HMG-CoA
reductase and cholesterol synthesis in the liver and by increasing the
number of LDL-C receptors on
the cell-surface of liver cells, providing for enhanced uptake