VEIKIRIN Film-coated tablet Ref.[50615] Active ingredients: Amitriptyline

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Strides Pharma SA (Pty) Ltd, 106 16th Road, Building 2, Midrand

Product name and form

VEIKIRIN 10 (film-coated tablets).

VEIKIRIN 25 (film-coated tablets).

VEIKIRIN 50 (film-coated tablets).

Pharmaceutical Form

Film-coated tablet.

VEIKIRIN 10: Round blue colored biconvex tablets debossed 1 on one side and plain on other side.

VEIKIRIN 25: Round yellow colored biconvex tablets plain on both sides.

VEIKIRIN 50: Round brown colored biconvex tablets plain on both sides.

Qualitative and quantitative composition

VEIKIRIN 10: Each film-coated tablet contains 10 mg amitriptyline hydrochloride.

Contains sugar: lactose monohydrate 10 mg.

VEIKIRIN 25: Each film-coated tablet contains 25 mg amitriptyline hydrochloride.

Contains sugar: lactose monohydrate 10 mg.

VEIKIRIN 50: Each film-coated tablet contains 50 mg amitriptyline hydrochloride.

Contains sugar: lactose monohydrate 20 mg.

For the full list of excipients, see section 6.1.

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

Tablet core:

Colloidal silicon dioxide
Corn maize starch
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Talc

Tablet coating VEIKIRIN 10:

Hypromellose
Macrogol 6000
Macrogol (E1521)
Polyvinyl alcohol (E1203)
Talc (E553b)
Titanium dioxide (E171)
FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133)

Tablet coating VEIKIRIN 25:

Hypromellose
Iron oxide yellow (E172)
Macrogol 6000
Macrogol (E1521)
Polyvinyl alcohol (E1203)
Talc (E553b)
Titanium dioxide (E171)

Tablet coating VEIKIRIN 50:

Hypromellose
Iron oxide yellow (E172)
Iron oxide red (E172)
Macrogol 6000
Macrogol (E1521)
Polyvinyl alcohol (E1203)
Talc (E553b)
Titanium dioxide (E171)

Pack sizes and marketing

VEIKIRIN 10 are packed in PVC/PVdC/Aluminium blisters containing 30 film-coated tablets. The blister strips are packed in a printed carton.

VEIKIRIN 25 are packed in PVC/PVdC/Aluminium blisters containing 30 or 60 film-coated tablets. The blister strips are packed in a printed carton.

VEIKIRIN 50 are packed in PVC/PVdC/Aluminium blisters containing 30 film-coated tablets. The blister strips are packed in a printed carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Strides Pharma SA (Pty) Ltd, 106 16th Road, Building 2, Midrand

Marketing authorization dates and numbers

VEIKIRIN 10: 54/1.2/0681
VEIKIRIN 25: 54/1.2/0682
VEIKIRIN 50: 54/1.2/0683

29 March 2022

Drugs

Drug Countries
VEIKIRIN South Africa

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