CODEINE PHOSPHATE Tablet Ref.[108794] Active ingredients: Codeine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2023  Publisher: Noumed Pharmaceuticals Limited, Auckland, New Zealand

Product name and form

Codeine Phosphate Tablets(Noumed) 15 mg, 30 mg & 60 mg tablets.

Pharmaceutical Form

Oral – tablet, uncoated.

Presentation: Codeine Phosphate Tablets (Noumed) are white to cream, biconvex circular tablets.

Qualitative and quantitative composition

Name and strength of the active substance:

Codeine Phosphate Hemihydrate BP 15 mg.

Codeine Phosphate Hemihydrate BP 30 mg.

Codeine Phosphate Hemihydrate BP 60 mg.

Codeine phosphate hemihydrate is obtained from opium or made by methylating morphine. It occurs as odourless colourless crystals or white crystalline powder. The molecular formula of codeine phosphate is C18H21NO3,H3PO4.½H2O and the molecular weight 406.4.

Excipient(s) with known effect:

Contains sugars as lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Codeine

Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain. The anti-tussive activity of codeine is probably due to its depressant effect on the medullary cough centre in the brain.
List of Excipients

For Codeine Phosphate Tablets (Noumed) 15 mg:

Maize starch
Lactose monohydrate
Magnesium stearate

For Codeine Phosphate Tablets (Noumed) 30 mg:

Acacia
Maize starch
Lactose monohydrate
Purified talc
Magnesium stearate

For Codeine Phosphate Tablets (Noumed) 60 mg:

Maize starch
Lactose monohydrate
Magnesium stearate

Pack sizes and marketing

Codeine Phosphate Tablets (Noumed) 15 mg:

Bottle, glass, 100 tablets.

Blister pack, 100 tablets.

Codeine Phosphate Tablets (Noumed) 30 mg:

Bottle, glass, 100 tablets.

Blister pack, 100 tablets.

Codeine Phosphate Tablets (Noumed) 60 mg:

Bottle glass, 100 tablets.

Blister pack, 100 tablets.

Marketing authorization holder

Noumed Pharmaceuticals Limited, Auckland, New Zealand

Marketing authorization dates and numbers

Date of first approval: 30/12/1969

 
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