ASPAVOR 80 TABLET

Valsts: Dienvidāfrikas Republika

Valoda: angļu

Klimata pārmaiņas: South African Health Products Regulatory Authority (SAHPRA)

Pieejams no:

Upjohn South Africa (Pty) Ltd

Deva:

See ingredients

Zāļu forma:

TABLET

Kompozīcija:

EACH TABLET CONTAINS ATORVASTATIN 80,0 mg

Autorizācija statuss:

Registered

Autorizācija datums:

2013-05-12

Lietošanas instrukcija

Viatris South Africa (Pty) Ltd
Page 1 of 9
Aspavor 10, 20, 40, 80 tablet
Final approved PIL – 05 October 2022
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
ASPAVOR
® 10 TABLET
ASPAVOR
® 20 TABLET
ASPAVOR
®
40 TABLET
ASPAVOR
®
80 TABLET
ATORVASTATIN
READ THIS LEAFLET CAREFULLY BEFORE YOU START USING ASPAVOR
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist.
•
ASPAVOR 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 ASPAVOR CONTAINS:
Each ASPAVOR tablet contains the active ingredient atorvastatin
calcium trihydrate, equivalent to
10/20/40/80 mg atorvastatin respectively.
ASPAVOR tablets contain the following inactive ingredients: Calcium
carbonate, microcrystalline cellulose,
lactose monohydrate, croscarmellose sodium, polysorbate 80,
hydroxypropyl cellulose and magnesium
stearate.
The coating of ASPAVOR 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 ASPAVOR IS USED FOR:
Viatris South Africa (Pty) Ltd
Page 2 of 9
Aspavor 10, 20, 40, 80 tablet
Final approved PIL – 05 October 2022
ASPAVOR belongs to a group of medicines known as lipid or cholesterol
(fat) regulating medicines
commonly known as statins.
ASPAVOR 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. ASPAVOR
is for adults and children over 10 whose
cholesterol does not come down enough with exercise and a low-fat diet
alone.
ASPAVOR can lower risk of heart disease and disorders of the blood
vessels of the brain, which are
conditions due to reduced blood

Produkta apraksts

Viatris South Africa (Pty) Ltd
Page 1 of 18
Aspavor 10, 20, 40, 80 tablet
Final approved PI – 05 October 2022
SCHEDULING STATUS: S4
PROPRIETARY NAME AND DOSAGE FORM:
ASPAVOR
® 10 TABLET
ASPAVOR
® 20 TABLET
ASPAVOR
®
40 TABLET
ASPAVOR
®
80 TABLET
COMPOSITION:
ASPAVOR 10: Each tablet contains atorvastatin calcium trihydrate,
equivalent to 10 mg atorvastatin.
ASPAVOR 20: Each tablet contains atorvastatin calcium trihydrate,
equivalent to 20 mg atorvastatin.
ASPAVOR 40: Each tablet contains atorvastatin calcium trihydrate,
equivalent to 40 mg atorvastatin.
ASPAVOR 80: Each tablet contains atorvastatin calcium trihydrate,
equivalent to 80 mg atorvastatin.
ASPAVOR tablets contain the following inactive ingredients: Calcium
carbonate, microcrystalline
cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80,
hydroxypropyl cellulose and
magnesium stearate.
The coating of ASPAVOR 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 South Africa (Pty) Ltd
Page 2 of 18
Aspavor 10, 20, 40, 80 tablet
Final approved PI – 05 October 2022
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 enhanc