Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: H. Lundbeck A/S, Ottilavaj 9, 2500 Valby, Denmark
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. |
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 |
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 Coating: Hypromellose |
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.
H. Lundbeck A/S, Ottilavaj 9, 2500 Valby, Denmark
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
| Drug | Countries | |
|---|---|---|
| CIPRALEX | Austria, Canada, Cyprus, Germany, Estonia, Spain, Finland, Croatia, Israel, Italy, Lithuania, Malta, Romania, Turkey, United Kingdom, South Africa |
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