RUBILIM Prolonged release tablet Ref.[108831] Active ingredients: Valproic acid

Source: Health Products Regulatory Authority (ZA)  Publisher: Ruby Pharmaceuticals (PTY) LTD, P.O. Box 431, Pinetown 3600

Product name and form

RUBILIM CR 200 mg (Prolonged release tablets).

RUBILIM CR 300 mg (Prolonged release tablets).

RUBILIM CR 500 mg (Prolonged release tablets).

Pharmaceutical Form

RUBILIM CR 200 mg is a film coated, oblonged shaped and violet coloured prolonged release tablet.

RUBILIM CR 300 mg is a film coated, oblonged shaped and blue coloured prolonged release tablet.

RUBILIM CR 500 mg is a film coated, oblonged shaped and violet coloured prolonged release tablet.

Qualitative and quantitative composition

RUBILIM CR 200: each prolonged release tablet contains 133,2 mg sodium valproate and 58,0 mg valproic acid equivalent to 200 mg sodium valproate.

RUBILIM CR 300: each prolonged release tablet contains 199,8 mg sodium valproate and 87,0 mg valproic acid equivalent to 300 mg Sodium Valproate.

RUBILIM CR 500: each prolonged release tablet contains 333,0 mg sodium valproate and 145,0 mg valproic acid equivalent to 500 mg sodium valproate.

Sugar free.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Valproic acid

Valproic acid is anti-convulsant. The most likely mode of action for valproate is potentiation of the inhibitory action of gamma amino butyric acid (GABA) through an action on the further synthesis or further metabolism of GABA.

List of Excipients

Tablet core:

Hypromellose
Ethylcellulose
Silicon dioxide

Coating:

Opadry OY-S-6705 violet
Opadry 09B505001 blue

Pack sizes and marketing

RUBILIM CR is packed in cold form ALU-ALU blister packs in cartons of 56, 60, 100 or 120 or 140 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Ruby Pharmaceuticals (PTY) LTD, P.O. Box 431, Pinetown 3600

Marketing authorization dates and numbers

6 April 2022

Drugs

Drug Countries
RUBILIM South Africa

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