LEXAMIL Film-coated tablet Ref.[115213] Active ingredients: Escitalopram

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2019  Publisher: CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530

Product name and form

LEXAMIL 5 (Tablets).

LEXAMIL 10 (Tablets).

LEXAMIL 20 (Tablets).

Pharmaceutical Form

LEXAMIL 5: White, round, biconvex, film-coated tablets plain on both sides.

LEXAMIL 10: White, round, biconvex, film-coated tablets plain on both sides.

LEXAMIL 20: White, round, biconvex, film-coated tablets plain on both sides.

Qualitative and quantitative composition

LEXAMIL 5: Each tablet contains escitalopram oxalate equivalent to 5 mg escitalopram.

LEXAMIL 10: Each tablet contains escitalopram oxalate equivalent to 10 mg escitalopram.

LEXAMIL 20: Each tablet contains escitalopram oxalate equivalent to 20 mg escitalopram.

Contains sugar: Mannitol:-

LEXAMIL 5: 34,36 mg/tablet.

LEXAMIL 10: 68,73 mg/tablet.

LEXAMIL 20: 137,45 mg/tablet.

Active Ingredient

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. The inhibition of 5-HT re-uptake is the only likely mechanism of action explaining the pharmacological and clinical effects of escitalopram.

List of Excipients

Inactive ingredients include:

Croscarmellose sodium
Magnesium stearate
Mannitol
Microcrystalline cellulose
Opadry 04F58804 white (hydroxyl propyl methyl cellulose, titanium dioxide and macrogol)
Corn starch

Pack sizes and marketing

LEXAMIL 5: Outer carton containing Aluminium foil/PVC/PVDC blister strips of 10 tablets packed in 30’s.

LEXAMIL 10: Outer carton containing Aluminium foil/PVC/PVDC blister strips of 10 tablets packed in 30’s.

LEXAMIL 20: Outer carton containing Aluminium foil/PVC/PVDC blister strips of 10 tablets packed in 30’s.

Marketing authorization holder

CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530

Marketing authorization dates and numbers

LEXAMIL 5: 41/1.2/0394
LEXAMIL 10: 41/1.2/0395
LEXAMIL 20: 41/1.2/0396

Drugs

Drug Countries
LEXAMIL South Africa

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