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

4.1. Therapeutic indications

Codeine phosphate is indicated for:

  • the relief of mild to moderate pain (including pain associated with terminal illness, post-operative pain, headache),
  • the relief of symptoms of diarrhoea (except diarrhoea caused by poisoning).

4.2. Posology and method of administration

Adults

Codeine phosphate may be given orally in doses of 15 mg – 60 mg every 4 – 6 hours as needed. If these doses fail to relieve pain, larger doses rarely succeed and may give rise to restlessness and excitement.

The maximum daily dose in adults should not exceed 300 mg.

Paediatric

Do not use in children aged less than 12 years (see sections 4.3 and 4.4).

The usual paediatric dose is 0.5 mg per kg of body weight, every 4 to 6 hours as needed. The total dose should not exceed 240 mg in 24 hours. The duration of treatment should not normally exceed 3 days.

4.9. Overdose

Symptoms

Signs of overdose may include nausea, vomiting, constipation, lack of appetite, somnolence, extreme sleepiness, confusion, shallow breathing, and coma.

Signs of overdose in children include excessive sleepiness, difficulty waking, difficulty breathing, confusion, slow heart rate, weak pulse, paradoxical excitation or restlessness, and coma.

Toxic doses vary considerably with the individual and regular users may tolerate larger doses.

Treatment

The stomach should be emptied by aspiration or lavage. A laxative may be given to aid peristalsis. Intensive supportive therapy may be required to correct respiratory failure and shocks. In addition, the specific antagonist naloxone hydrochloride is used to counteract very rapidly the severe respiratory depression and coma produced by excessive doses of opioid analgesics. A dose of 0.4mg to 2mg is given intravenously, intramuscularly or subcutaneously, repeated at intervals of 2 to 3 minutes, if necessary, up to 10mg. The effect of naloxone may be of shorter duration than that of the opioid analgesic and additional doses may be required to prevent relapses.

The use of opioid antagonists such as naloxone, nalorphine and levallorphan in persons physically dependent on opioid agonists may induce withdrawal symptoms.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

6.3. Shelf life

Glass bottles: 36 months from date of manufacture when stored at 25°C.

Blister pack: 24 months from date of manufacture when stored at 25°C.

6.4. Special precautions for storage

Protect from light and moisture. Store at or below 25°C. Keep out of reach of children.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

Any unused medicine or waste material should be disposed of in accordance with local requirements.

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