ALIPTO Film-coated tablet Ref.[115235] Active ingredients: Atorvastatin

Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Unimed Healthcare (Pty) Ltd, Corner Birch Road and Bluegum Avenue, Anchorville, Lenasia, 1827, South Africa

Product name and form

ALIPTO 10 (film-coated tablets).

ALIPTO 20 (film-coated tablets).

ALIPTO 40 (film-coated tablets).

ALIPTO 80 (film-coated tablets).

Pharmaceutical Form
Film-coated tablets. ALIPTO 10: White colored, oval shaped, biconvex film coated tablets with one side embossed “10” and other side plain. ALIPTO 20: White colored, oval shaped, biconvex film coated tablets with one side embossed “20” and other side plain. ALIPTO 40: White colored, oval shaped, biconvex film coated tablets with one side embossed “40” and other side plain. ALIPTO 80: White colored, oval shaped, biconvex film coated tablets with one side embossed “80” and other side plain.

Qualitative and quantitative composition

ALIPTO 10:

Each film-coated tablet contains atorvastatin calcium trihydrate, equivalent to 10 mg atorvastatin.

Contains sugar: mannitol 70,97 mg per tablet.

Also contains: 2,93 mg of sodium per tablet.

ALIPTO 20:

Each film-coated tablet contains atorvastatin calcium trihydrate, equivalent to 20 mg atorvastatin.

Contains sugar: mannitol 141,94 mg per tablet.

Also contains: 5,86 mg of sodium per tablet.

ALIPTO 40:

Each film-coated tablet contains atorvastatin calcium trihydrate, equivalent to 40 mg atorvastatin.

Contains sugar: mannitol 283,88 mg per tablet.

Also contains: 11,72 mg of sodium per tablet.

ALIPTO 80:

Each film-coated tablet contains atorvastatin calcium trihydrate, equivalent to 80 mg atorvastatin.

Contains sugar: mannitol 567,76 mg per tablet.

Also contains: 23,44 mg of sodium per tablet.

ALIPTO 10/ 20/ 40/ 80:

Contains Butylated hydroxyanisole as an antioxidant.

For the full list of excipients, see section 6.1.

Active Ingredient
Atorvastatin
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase. Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

List of Excipients
Tablet core: Mannitol Sodium laury sulfate Colloidal anhydrous silica Anhydrous sodium carbonate Butylated hydroxyanisole Microcrystalline cellulose Croscarmellose sodium Magnesium stearate Film coating: Septifilm LP 010 (hypromellose, microcrystalline cellulose and stearic acid)

Pack sizes and marketing

ALIPTO 10/20/40/80:

Pack size: 28 tablets or 30 tablets.

Tablets are packed in Alu-Alu blister composed of silver opaque Alu-Alu cold form laminate & silver opaque Aluminium foil. Each blister strip contains 7 tablets or 10 tablets. Four blister strips of 7’s or three blister strips of 10’s are packed in an outer carton.

Marketing authorization holder

Unimed Healthcare (Pty) Ltd, Corner Birch Road and Bluegum Avenue, Anchorville, Lenasia, 1827, South Africa

Marketing authorization dates and numbers

ALIPTO 10: 48/7.5/1206
ALIPTO 20: 48/7.5/1207
ALIPTO 40: 48/7.5/1208
ALIPTO 80: 48/7.5/1209

Date of registration: 25 November 2016

Drugs

Drug	Countries
ALIPTO	South Africa

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