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OTEZLA Film-coated tablets (2019)

Active ingredients: Apremilast

Product Name and Form

Otezla 10 mg film-coated tablets.

Otezla 20 mg film-coated tablets.

Otezla 30 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet (tablet).

Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with “APR” engraved on one side and “10” on the opposite side.

Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with “APR” engraved on one side and “20” on the opposite side.

Beige, diamond shaped 30 mg film-coated tablet of 12 mm length with “APR” engraved on one side and “30” on the opposite side.

Qualitative and Quantitative Composition

Each film-coated tablet contains 10 mg of apremilast.

Each film-coated tablet contains 20 mg of apremilast.

Each film-coated tablet contains 30 mg of apremilast.

Excipient(s) with known effect:

Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate).

Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate).

Each film-coated tablet contains 171 mg of lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Apremilast

Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells.

List of excipients

Tablet core:

Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Magnesium stearate

Film-coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc
Iron oxide red (E172)

The 20 mg tablets also contain iron oxide yellow (E172).

The 30 mg tablets also contain iron oxide yellow (E172) and iron oxide black(E172).

Pack sizes and Marketing

The treatment initiation pack contains 27 film-coated tablets (4 x10 mg, 4x 20 mg, 19 × 30 mg).

Not all pack sizes may be marketed

Marketing authorization holder
Authorization dates

Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands

Date of first authorisation: 15 January 2015

Marketing authorization number:

EU/1/14/981/001