CIPRALEX Film-coated tablets

Active ingredients: Escitalopram

Product name and form

CIPRALEX 5 mg film-coated tablets.
CIPRALEX 10 mg film-coated tablets.
CIPRALEX 20 mg film-coated tablets.

Pharmaceutical Form

Cipralex 5 mg: Round, white, film-coated tablet of 6 mm marked with “EK” on one side.

Cipralex 10 mg: Oval, white, scored, film-coated tablet of 8 × 5.5 mm marked with “E” and “L” on each side of the score on one side of the tablet.

Cipralex 20 mg: Oval, white, scored, film-coated tablet of 11.5 × 7 mm marked with “E” and “N” on each side of the score on one side of the tablet.

The 10 mg and 20 mg tablets can be divided into equal doses.

Qualitative and quantitative composition

Cipralex 5 mg: Each tablet contains 5 mg escitalopram (as oxalate).

Cipralex 10 mg: Each tablet contains 10 mg escitalopram (as oxalate).

Cipralex 20 mg: Each tablet contains 20 mg escitalopram (as oxalate).

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a 1000 fold lower affinity.

List of Excipients

Tablet core:

Microcrystalline cellulose
Colloidal anhydrous silica
Talc
Croscarmellose sodium
Magnesium stearate

Coating:

Hypromellose
Macrogol 400
Titanium dioxide (E171)

Pack sizes and marketing

Blister: Transparent; PVC/PE/PVdC/Aluminium blister, pack with an outer carton; 14, 28, 56, 98 tablets – Unit dose; 49x1, 56x1, 98x1, 100x1, 500x1 tablets (5, 10 and 20 mg)

Blister: White; PVC/PE/PVdC/Aluminium blister, pack with an outer carton; 14, 20, 28, 50, 100, 200 tablets (5, 10 and 20 mg)

High Density Polyethylene (HDPE) tablet container; 100 tablets (5, 10 and 20 mg), 200 tablets (5 and 10 mg)

Not all pack sizes may be marketed.

Marketing authorization holder

H. Lundbeck A/S, Ottilavaj 9, 2500 Valby, Denmark

Marketing authorization dates and numbers

Cipralex 5 mg film-coated tablets: PL 13761/0008
Cipralex 10 mg film-coated tablets: PL 13761/0009
Cipralex 20 mg film-coated tablets: PL 13761/0011

10 June 2002/13 January 2016

Drugs

Drug
Countries
Austria, Canada, Cyprus, Germany, Spain, Lithuania, United Kingdom