LUSTRAL Film-coated tablet Ref.[49978] Active ingredients: Sertraline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Upjohn UK Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

Product name and form

LUSTRAL 50 mg film coated tablets.

Pharmaceutical Form

Film-coated tablet.

Sertraline 50 mg film-coated tablets are white, capsular shaped (10.3 × 4.2 mm), film-coated scored tablets marked ‘ZLT 50’ on one side and ‘PFIZER’ on the other. The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each 50 mg film-coated tablet contains sertraline hydrochloride equivalent to 50 mg sertraline.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sertraline

Sertraline is a potent and specific inhibitor of neuronal serotonin (5-HT) uptake in vitro, which results in the potentiation of the effects of 5-HT in animals. It has only very weak effects on norepinephrine and dopamine neuronal reuptake.

List of Excipients

Sertraline film-coated tablets

Tablet cores:

calcium hydrogen phosphate dihydrate (E341)
microcrystalline cellulose (E460)
hydroxypropylcellulose (E463)
sodium starch glycollate (Type A)
magnesium stearate (E572)

Film coating:

Opadry White containing:

titanium dioxide (E171)
hypromellose 2910, 3 mPas (E464)
hypromellose 2910, 6 mPas (E464)
macrogol 400 (E1521)
polysorbate 80 (E433)

Opadry Clear containing:

hypromellose 2910, 6 mPas (E464)
macrogol 400 (E1521)
macrogol 8000 (E1521)

Pack sizes and marketing

Tablets are packed in Aluminium/PVC blisters of 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300, or 500 tablets.

Tablets are packed in Aluminium/PVC blister strips containing 30x1.

Not all pack sizes may be marketed.

Marketing authorization holder

Upjohn UK Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 50622/0045

23/06/2009

Drugs

Drug Countries
LUSTRAL Ireland, Israel, Turkey, United Kingdom

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