CODEINE PHOSPHATE TABLETS Uncoated tablet

Active ingredients: Codeine

Product name and form

CODEINE PHOSPHATE TABLETS BP 15mg.

Pharmaceutical Form

White uncoated tablets.

Qualitative and quantitative composition

Each tablet contains 15mg Codeine phosphate hemihydrate.

Each tablet contains 17.00mg lactose BP.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

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.

List of Excipients

Also contains lactose, magnesium stearate, maize starch, pregelatinised maize starch, stearic acid.

Pack sizes and marketing

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.

The product may also be supplied in blister packs in cartons:

  • Carton: Printed carton manufactured from white folding box board.
  • Blister pack:
    • 250µm white rigid PVC.
    • Surface printed 20µm hard temper aluminium foil with 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material.

Maximum size of bulk packs: 50,000.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/6458 R

(Product Licence of Right issued: Pre 1974) 2.11.81 / 30.06.02