NEURALYN Capsule, hard Ref.[115175] Active ingredients: Pregabalin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: Unicorn Pharmaceuticals (Pty) Ltd, Cnr. Searle & Pontac Streets, Cape Town, South Africa, 8001

Product name and form

NEURALYN 25 mg hard capsules.

NEURALYN 50 mg hard capsules.

NEURALYN 75 mg hard capsules.

NEURALYN 100 mg hard capsules.

NEURALYN 150 mg hard capsules.

Pharmaceutical Form

Capsules, hard.

NEURALYN 25: White powder in a white cap and white body hard gelatin capsule, imprinted with “25” on the body.

NEURALYN 50: White powder in a white cap and white body hard gelatin capsule, imprinted with “50” on the body.

NEURALYN 75: White powder in a Swedish orange cap and white body hard gelatin capsule, imprinted with “75” on the body.

NEURALYN 100: White powder in a Swedish orange cap and Swedish orange body hard gelatin capsule, imprinted with “100” on the body.

NEURALYN 150: White powder in a white cap and white body hard gelatin capsule, imprinted with “150” on the body.

Qualitative and quantitative composition

Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of pregabalin.

Sugar content:

NEURALYN 25: Each hard capsule also contains 10,6 mg of sugar (mannitol)

NEURALYN 50: Each hard capsule also contains 21,2 mg of sugar (mannitol)

NEURALYN 75: Each hard capsule also contains 31,8 mg of sugar (mannitol)

NEURALYN 100: Each hard capsule also contains 42,4 mg of sugar (mannitol)

NEURALYN 150: Each hard capsule also contains 63,6 mg of sugar (mannitol).

For full list of excipients, see section 6.1.

Active Ingredient

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

List of Excipients

Neuralyn 25 mg, 50 mg, 75 mg, 100 mg and 150 mg hard capsules

Capsules content:

Pregelatinised Starch
Mannitol (spray dried)
Talc

Capsules shell:

Gelatin
Titanium dioxide (E171)
Red Iron Oxide E172 (additional in Neuralyn 75 mg and Neuralyn 100 mg)

Black printing ink:

Shellac Glaze-45% (20% esterified) in ethanol
Iron oxide black (E172)
Propylene glycol (E1520)
Ammonium hydroxide 28% (E527)

Pack sizes and marketing

This medicine is packaged in a cardboard box containing PVC-Aluminum foil blisters or in white opaque HDPE bottles with child resistant screw caps.

Blister pack sizes of: 14, 56, 60 or 100 (blisters of 7 or 10 capsules), and

HDPE bottles containing 60 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Unicorn Pharmaceuticals (Pty) Ltd, Cnr. Searle & Pontac Streets, Cape Town, South Africa, 8001

Marketing authorization dates and numbers

NEURALYN 25 mg: 51/2.5/0895
NEURALYN 50 mg: 51/2.5/0896
NEURALYN 75 mg: 51/2.5/0897
NEURALYN 100 mg: 51/2.5/0898
NEURALYN 150 mg: 51/2.5/0899

Date of the registration certificate: 22 February 2022

Drugs

Drug Countries
NEURALYN South Africa

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