SERTRALINE Film coated tablet Ref.[7083] Active ingredients: Sertraline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Product name and form

Sertraline 100mg Film coated Tablets.

Pharmaceutical Form

Film coated Tablet.

White coloured, biconvex, capsule shaped, film coated tablets debossed with ‘IJ’ on one side and plain on other side.

Qualitative and quantitative composition

Each film-coated tablet contains 100mg sertraline (as sertraline hydrochloride).

For a 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

Core tablets:

Calcium hydrogen phosphate dihydrate
Cellulose microcrystalline
HydroxypropylcelluloseSodium starch glycolate (Type A)
Magnesium stearate

Film coating:

Opadry White OY-S-7355 containing:

Titanium dioxide (E171)
Hypromellose
Macrogol 400
Polysorbate-80

Pack sizes and marketing

White opaque PVC – Aluminium blister or white opaque PVdC – PVC Aluminium blisters.

Packs of 10, 14, 28, 30, 42, 50, 56, 84, 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0068

28/07/2008

Drugs

Drug Countries
SERTRALINE Hong Kong

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