Active ingredients: Atorvastatin
Lipitor 10 mg film-coated tablets.
Film-coated tablet.
White, round, 5.6 mm, film-coated tablets debossed ‘10’ on one side and ‘ATV’ on the other.
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate).
Excipient(s) with known effect: Each Lipitor 10 mg film-coated tablet contains 27.25 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
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.
Tablet core:
Calcium carbonate
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Polysorbate 80
Hydroxypropyl cellulose
Magnesium stearate
Film coat:
Film coating containing:
Hypromellose
Macrogol 8000
Titanium dioxide (E171)
Talc
Simethicone emulsion containing:
Simethicone
Stearate emulsifiers (polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides)
Thickeners (methylcellulose, xanthan gum)
Benzoic acid
Sorbic acid
Sulfuric acid
The blisters consist of a forming film made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl heat-seal coating.
The bottle is made of HDPE, containing desiccant, with squeeze-and-turn child-resistant closure.
Blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets.
Hospital packs containing 50, 84, 100, 200 (10 × 20) or 500 film-coated tablets.
HDPE bottle containing 90 film-coated tablets.
Not all pack sizes may be marketed.
Pfizer Ireland Pharmaceuticals, Operations Support Group, Ringaskiddy, Co Cork, Ireland
PL 39933/0001
Date of first authorisation: 8 September 1997
Date of latest renewal: 03 March 2013