NUBACAP Hard gelatine capsule Ref.[51233] Active ingredients: Pregabalin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Forrester Pharma (Pty) Ltd, 2 Waterford Mews, Waterford Place, Century City, 7441, Cape Town, South Africa

Product name and form

NUBACAP 25 hard gelatine capsule.

NUBACAP 75 hard gelatine capsule.

NUBACAP 150 hard gelatine capsule.

Pharmaceutical Form

NUBACAP 25: Opaque white, size “4” hard gelatine capsules, radially imprinted with ‘A’ on cap and ‘140’ on body with black ink, filled with white to offwhite powder.

NUBACAP 75: Opaque white and opaque orange, size “4” hard gelatine capsules, radially imprinted with ‘A’ on cap and ‘142’ on body with black ink, filled with white to off-white powder.

NUBACAP 150: Opaque white, size “2” hard gelatine capsules, radially imprinted with ‘A’ on cap and ‘144’ on body with black ink, filled with white to off-white powder.

Qualitative and quantitative composition

NUBACAP 25: Each capsule contains 25 mg pregabalin.

NUBACAP 75: Each capsule contains 75 mg pregabalin.

NUBACAP 150: Each capsule contains 150 mg pregabalin.

NUBACAP is sugar free.

For 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

Capsule content:

Pregelatinised starch
Talc

Capsule shell:

Gelatine
Titanium dioxide

The capsule shell of NUBACAP 75 also contains iron oxide red (colourant).

Printing ink:

Black iron oxide
Shellac

Pack sizes and marketing

NUBACAP 25, 75 and 150 are packed in blister strips of clear PVC/aluminium and packed into an outer cartons.

Pack size: 10, 14, 56, 60 or 100 capsules.

Marketing authorization holder

Forrester Pharma (Pty) Ltd, 2 Waterford Mews, Waterford Place, Century City, 7441, Cape Town, South Africa

Marketing authorization dates and numbers

NUBACAP 25: 48/2.5/1339
NUBACAP 75: 48/2.5/1340
NUBACAP 150: 48/2.5/1341

12 November 2019

Drugs

Drug Countries
NUBACAP South Africa

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