ACOMPLIA Film-coated tablet Ref.[9172] Active ingredients: Rimonabant

Source: European Medicines Agency (EU)  Revision Year: 2009  Publisher: sanofi-aventis, 174 Avenue de France, F-75013, Paris, France

Product name and form

ACOMPLIA 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Biconvex, teardrop-shaped, white tablets debossed with “20” on one side.

Qualitative and quantitative composition

Each tablet contains 20 mg rimonabant.

Excipients: The tablets contain approx. 115 mg lactose.

For a full list of excipients, see section 6.1.

Active Ingredient Description

Rimonabant is a selective cannabinoid-1 receptor (CB1) antagonist that inhibits the pharmacological effects of cannabinoid agonists in vitro and in vivo. The endocannabinoid system is a physiological system present in brain and peripheral tissues (including adipocytes) that affects energy balance, glucose and lipid metabolism and body weight, and in neurons of the mesolimbic system modulates the intake of highly palatable, sweet or fatty foods.

List of Excipients

Tablet core:

Maize starch
Lactose monohydrate
Povidone K 30 (E1201)
Croscarmellose sodium (E468)
Sodium laurilsulfate (E487)
Microcrystalline cellulose (E460)
Magnesium stearate

Tablet coating:

Lactose monohydrate
Hypromellose 15 mPa.s (E464)
Titanium dioxide (E171)
Macrogol 3000

Tablet polishing:

Carnauba wax (E903)

Pack sizes and marketing

PVC-aluminium blister packs containing 14, 28, 30, 56, 84, 90 and 98 film-coated tablets.

70 × 1 film-coated tablets in PVC-aluminium perforated unit dose blister packs.

Opaque white HDPE bottles containing 28, 98 and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

sanofi-aventis, 174 Avenue de France, F-75013, Paris, France

Marketing authorization dates and numbers


19 June 2006

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