TREPILINE Film-coated tablet Ref.[51235] Active ingredients: Amitriptyline

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2017  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Product name and form

TREPILINE 10 (tablets).

TREPILINE 25 (tablets).

Pharmaceutical Form

TREPILINE 10: Pale blue, round, shallow, biconvex, film-coated tablets, plain on both sides.

TREPILINE 25: Yellow, round, shallow, biconvex, film-coated tablet, plain on both sides.

Qualitative and quantitative composition

TREPILINE 10

Each tablet contains 10 mg amitriptyline hydrochloride.

Excipients: Colloidal silicon dioxide, disodium edetate, indigo carmine aluminium lake 73015, lactose monohydrate, macrogol, magnesium stearate, polyvinyl alcohol, starch (maize), starch (pregelatinised), sunset yellow FCF aluminium lake 15985, talc, titanium dioxide 77891, quinolene yellow aluminium lake 47005.

Contains sugar: Lactose monohydrate 60 mg.

TREPILINE 25

Each tablet contains 25 mg amitriptyline hydrochloride.

Excipients: Colloidal silicon dioxide, disodium edetate, indigo carmine aluminium lake 73015, iron oxide yellow 77492, lactose monohydrate, macrogol, magnesium stearate, polyvinyl alcohol, starch (maize), starch (pregelatinised), sunset yellow FCF aluminium lake 15985, talc, titanium dioxide 77891, quinolene yellow aluminium lake 47005.

Contains sugar: Lactose monohydrate 40 mg.

Active Ingredient Description
Amitriptyline

Amitriptyline is a tricyclic antidepressant and an analgesic. It prevents the re-uptake, and hence the inactivation of noradrenaline and serotonin at nerve terminals. Reuptake prevention of these monoamine neurotransmitters potentiate their action in the brain. This appears to be associated with the antidepressant activity.

List of Excipients

Colloidal silicon dioxide
Disodium edetate
Indigo carmine aluminium lake 73015
Lactose monohydrate
Macrogol
Magnesium stearate
Polyvinyl alcohol
Starch (maize)
Starch (pregelatinised)
Sunset yellow FCF aluminium lake 15985
Talc
Titanium dioxide 77891
Quinolene yellow aluminium lake 47005

Pack sizes and marketing

TREPILINE 10: Packs of 100 and 500 tablets in white polypropylene securitainers together with a foam insert/rayon and professional information which is sealed with white, low density polyethylene securitainer caps.

Packs of 28 tablets into metallised patient ready packs which are sealed with lay-flat zips after filling and packed into polyethylene bags.

TREPILINE 25: Packs of 100 and 500 tablets in white polypropylene securitainers together with a foam insert/rayon and professional information which is sealed with white low density polyethylene securitainer caps.

Packs of 28 and 84 tablets into metallised patient ready packs which are sealed with lay-flat zips after filling and packed into polyethylene bags.

Not all packs and pack sizes are necessarily marketed.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Marketing authorization dates and numbers

TREPILINE 10: J/1.2/219
TREPILINE 25: J/1.2/220

Drugs

Drug Countries
TREPILINE South Africa

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