NURIKA Hard capsule Ref.[50571] Active ingredients: Pregabalin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Teva Pharmaceuticals (Pty) Ltd, Maxwell Office Park, Magwa Crescent West, Waterfall City, Midrand, Gauteng, 2090, South Africa Tel: (011) 055 0200

Product name and form

NURIKA 25 (capsule).
NURIKA 50 (capsule).
NURIKA 75 (capsule).
NURIKA 150 (capsule).

Pharmaceutical Form

NURIKA hard gelatin capsules contain a white to off-white, granulated powder.

NURIKA 25: Ivory opaque hard gelatin capsule imprinted in black with ‘25’ on the capsule body.

NURIKA 50: Ivory opaque hard gelatin capsule with the capsule cap imprinted with a radial black band and the
capsule body imprinted in black with ‘50’ and a radial black band.

NURIKA 75: Opaque hard gelatin capsule with a pink cap and ivory body imprinted in black with ‘75’.

NURIKA 150: Ivory opaque hard gelatin capsule imprinted in black with ‘150’ on the capsule body.

Qualitative and quantitative composition

Each hard capsule contains 25 mg, 50 mg, 75 mg, or 150 mg of pregabalin.

Contains sugar (mannitol).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Pregabalin

Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.

List of Excipients

Maize starch
Mannitol
Talc

Capsule shell contains:

Colourants (titanium dioxide, yellow iron oxide and red iron oxide)
Gelatin

Pack sizes and marketing

NURIKA 25, 50, 75 & 150 are packed in PVC/aluminium blisters. The blister consists of a silver/grey aluminum foil with a transparent, colourless PVC foil. Blisters are contained in an outer carton.

Pack size 14: Each carton contains 1 blister strip with 14 capsules per blister.

Pack size 56: Each carton contains 4 blister strips with 14 capsules per blister.

Pack size 60: Each carton contains 6 blister strips with 10 capsules per blister.

Pack size 100: Each carton contains 10 blister strips with 10 capsules per blister.

NURIKA 75 is packed in a white, high density polyethylene (HDPE) 150 ml bottle, with a white polypropylene closure with an inner seal. Pack size: 200 capsules.

NURIKA 150 is packed in a white, high density polyethylene (HDPE) 300 ml bottle, with a white polypropylene closure with an inner seal. Pack size: 200 capsules.

Not all pack sizes are marketed.

Marketing authorization holder

Teva Pharmaceuticals (Pty) Ltd, Maxwell Office Park, Magwa Crescent West, Waterfall City, Midrand, Gauteng, 2090, South Africa
Tel: (011) 055 0200

Marketing authorization dates and numbers

NURIKA 25: 46/2.5/0772.764
NURIKA 50: 46/2.5/0773.765
NURIKA 75: 46/2.5/0774.766
NURIKA 150: 46/2.5/0775.767

23 November 2017

Drugs

Drug Countries
NURIKA South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.