DEZZOLIP Film-coated tablet Ref.[50473] Active ingredients: Atorvastatin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Unicorn Pharmaceuticals (Pty) Ltd, Corner Searle & Pontac Streets, Cape Town, 8000 enquires@unicornpharma.co.za

Product name and form

DEZZOLIP 10 (film coated tablet).
DEZZOLIP 20 (film coated tablet).
DEZZOLIP 40 (film coated tablet).
DEZZOLIP 80 (film coated tablet).

Pharmaceutical Form

DEZZOLIP 10: White colored, oval shaped, biconvex film coated tablets with one side embossed “10” and other side plain.

DEZZOLIP 20: White colored, oval shaped, biconvex film coated tablets with one side embossed “20” and other side plain.

DEZZOLIP 40: White colored, oval shaped, biconvex film coated tablets with one side embossed “40” and other side plain

DEZZOLIP 80: White colored, oval shaped, biconvex film coated tablets with one side embossed “80” and other side plain.

Qualitative and quantitative composition

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

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

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

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

DEZZOLIP 10 contains sugar (mannitol 70,97 mg/tablet).
DEZZOLIP 20 contains sugar (mannitol 141,94 mg/tablet).
DEZZOLIP 40 contains sugar (mannitol 283,88 mg/tablet).
DEZZOLIP 80 contains sugar (mannitol 567,76 mg/tablet).

For the full list of excipients, see section 6.1

Active Ingredient Description
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

Inactive ingredients

The excipients are: anhydrous sodium carbonate, butylated hydroxyanisole, colloidal anhydrous silica, croscarmellose sodium, mannitol, microcrystalline cellulose, septifilm LP 010 (hypromellose, microcrystalline cellulose and stearic acid) and sodium lauryl sulphate.

Pack sizes and marketing

DEZZOLIP 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

Unicorn Pharmaceuticals (Pty) Ltd, Corner Searle & Pontac Streets, Cape Town, 8000
enquires@unicornpharma.co.za

Marketing authorization dates and numbers

DEZZOLIP 10: 48/7.5/1202
DEZZOLIP 20: 48/7.5/1203
DEZZOLIP 40: 48/7.5/1204
DEZZOLIP 80: 48/7.5/1205

Date of registration: 25 November 2016

Drugs

Drug Countries
DEZZOLIP South Africa

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