APO-NICOTINIC ACID Tablet Ref.[10967] Active ingredients: Nicotinic acid

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2017  Publisher: Apotex NZ Ltd., 32 Hillside Road, Glenfield, AUCKLAND 0627 Telephone: (09) 444 2073, Fax: (09) 444 2951, E-mail: NZcustomerservice@apotex.com

Product name and form

APO-NICOTINIC ACID (50mg & 500mg tablets).

Pharmaceutical Form

APO-NICOTINIC ACID 50mg tablets are white, round, 7mm in diameter, flat faced with beveled edged. Each tablet contains 50mg nicotinic acid and typically weighs 130mg.

APO-NICOTINIC ACID 500mg tablets are white, round, biconvex tablets, 12.5mm in diameter. Each tablet contains 500mg nicotinic acid and typically weighs 623mg.

Qualitative and quantitative composition

Nicotinic acid 50 mg.
Nicotinic acid 500 mg.

Excipient with known effect: Lactose.

Apo-Nicotinic acid contain Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Apo-Nicotinic acid is gluten free.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Nicotinic acid

Niacin (nicotinic acid) is an essential B complex Vitamin (B3), whose deficiency results in the clinical syndrome known as pellagra. Nicotinamide (niacinamide), the active ingredient, is the physiologically active form of niacin and is the chemical form of Vitamin B3 found in virtually all multivitamin products. Though nicotinic acid and nicotinamide are so closely related chemically, they differ somewhat in pharmacological properties.

List of Excipients

Apo-Nicotinic acid 50 mg tablet contains the following excipients:

  • Povidone
  • Lactose
  • Ethanol
  • Aerosil
  • Magnesium Stearate

Apo-Nicotinic acid 500 mg tablets contains the following excipients:

  • Povidone
  • Ethanol
  • Colloidal Silicon Dioxide
  • Croscarmellose Sodium
  • Lactose monohydrate
  • Magnesium Stearate

Apo-Nicotinic acid 50 mg and 500 mg tablets contain Lactose and small amounts of ethanol. Apo-Nicotinic acid is gluten free.

Pack sizes and marketing

APO-NICOTINIC ACID 50mg tablets: HDPE Bottles of 100 or 500 tablets.

APO-NICOTINIC ACID 500mg tablets: HDPE Bottles of 100 or 500 tablets.

Not all pack sizes maybe marketed.

Marketing authorization holder

Apotex NZ Ltd., 32 Hillside Road, Glenfield, AUCKLAND 0627
Telephone: (09) 444 2073, Fax: (09) 444 2951, E-mail: NZcustomerservice@apotex.com

Marketing authorization dates and numbers

31 December 1969

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