EZETIMIBE SANDOZ Tablet

Active ingredients: Ezetimibe

Product name and form

Ezetimibe 10mg Tablets.

Pharmaceutical Form

Tablet.

White to almost white, oval tablets (7.4 mm x 4.1 mm) with debossing “10” on one side and “EZT” on the other side.

Qualitative and quantitative composition

Each tablet contains 10 mg of ezetimibe.

Excipient(s) with known effect: 68 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Ezetimibe is in a new class of lipid-lowering compounds that selectively inhibit the intestinal absorption of cholesterol. The molecular target of ezetimibe is the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is responsible for the intestinal uptake of cholesterol.

List of Excipients

Lactose monohydrate
Hypromellose
Croscarmellose sodium
Microcrystalline cellulose
Sodium lauryl sulfate
Magnesium stearate

Pack sizes and marketing

Al/Al blister or PVC/PVDC/Al blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 100 (hospital pack) tablets.

White HDPE container closed with white, tamper-evident polypropylene screw cap with mounted LDPE capsule with silica gel: 100 tablets and 250 tablets (for hospital use and dose dispensing pharmacies only).

Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization dates and numbers

PL 04416/1387

21/01/2014