TRINTOGEN Film-coated tablet Ref.[115287] Active ingredients: Vortioxetine

Source: Health Products Regulatory Authority (ZA)  Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Customer Care: 0860/ADCOCK (232625)

Product name and form

TRINTOGEN 5 5 mg Film-coated tablets.

TRINTOGEN 10 10 mg Film-coated tablets.

TRINTOGEN 20 20 mg Film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

TRINTOGEN 5: Pink, almond-shaped, biconvex film-coated tablet debossed with "L" on one side and "07" on the other side (approximately 6,0 mm in length and 3,3 mm in width).

TRINTOGEN 10: Yellow, almond-shaped, biconvex film-coated tablet debossed with "L" on one side and "08" on the other side (approximately 7,2 mm in length and 4,2 mm in width).

TRINTOGEN 20: Red, almond-shaped, biconvex film-coated tablet debossed with '612' on one side and plain on other side (approximately 8,8 mm in length and 5,2 mm in width).

Qualitative and quantitative composition

TRINTOGEN 5: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine.

TRINTOGEN 10: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine.

TRINTOGEN 20: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine.

  • TRINTOGEN 5: Contains sugar (mannitol): 12,5 mg per film-coated tablet.
  • TRINTOGEN 10: Contains sugar (mannitol): 25,0 mg per film-coated tablet.
  • TRINTOGEN 20: Contains sugar (mannitol): 50 mg per film-coated tablet.

For full list of excipients, see section 6.1.

Active Ingredient

Vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter, leading to modulation of neurotransmission in several systems, including predominantly the serotonin but probably also the norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate systems. This multimodal activity is considered responsible for the antidepressant and anxiolytic-like effects and the improvement of cognitive function, learning and memory observed with vortioxetine in animal studies.

List of Excipients

Colloidal anhydrous silica
Hydroxypropyl cellulose
Magnesium stearate
Mannitol
Microcrystalline cellulose
Sodium stearyl fumarate

Coating:

TRINTOGEN 5:

Opadry Pink 03F84770, consisting of:

HPMC 2910/Hypromellose
Iron oxide red
Macrogol/PEG
Talc
Titanium dioxide

TRINTOGEN 10:

Opadry Yellow 03F520217, consisting of:

Ferrosoferric oxide/black iron oxide
HPMC 2910/Hypromellose
Iron oxide yellow
Macrogol/PEG
Titanium dioxide

TRINTOGEN 20:

Opadry Brown 03F565072, consisting of:

Ferrosoferric oxide/black iron oxide
HPMC 2910/Hypromellose
Iron oxide red
Macrogol/PEG
Titanium dioxide

Pack sizes and marketing

TRINTOGEN is packed in Alu/Alu blister pack of cold form blister (made of OPA film, soft tempered aluminium foil and PVC film) and aluminium foil. Such blisters are further packed in a carton along with the professional information and patient information leaflet.

Available in pack sizes of 28's and 30's.

Not all pack sizes may be marketed.

Marketing authorization holder

Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Customer Care: 0860/ADCOCK (232625)

Marketing authorization dates and numbers

TRINTOGEN 5: 55/1.2/0129
TRINTOGEN 10: 55/1.2/0130
TRINTOGEN 20: 55/1.2/0131

19 July 2022

Drugs

Drug Countries
TRINTOGEN South Africa

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