CODANT Tablet Ref.[108792] Active ingredients: Codeine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Mercury Pharmaceuticals (Ireland) Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin, Ireland

4.1. Therapeutic indications

1) Management of mild to moderate pain.

Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone.

2) As an anti-tussive for non-productive cough.

4.2. Posology and method of administration

Posology

Adults

The usual dose is 30mg (one tablet), repeated 6 hourly as required.

Codeine should be used at the lowest effective dose for the shortest period of time. This dose may be taken, up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose should not exceed 240 mg.

The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.

Elderly

A reduced dosage may be necessary.

Paediatric population

Children aged 12 years to 18 years

“The recommended codeine dose for children 12 years and older should be 30 to 60 mg every 6 hours when necessary up to a maximum dose of 240 mg daily. The dose is based on the body weight (0.5-1mg/kg)”.

Children aged less than 12 years

"Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4).

Dosage needs to be adjusted according to the severity of pain and the response of the patient.

Method of administration

Codant tablets are for oral administration only.

4.9. Overdose

Symptoms

Serious overdosage with codeine is characterised by respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils and respiratory depression is strongly suggestive of opiate poisoning.

Management

In cases of recent overdosage, the stomach should be emptied by aspiration and lavage. A patent airway should be maintained and assisted or controlled ventilation should be instituted if required. The narcotic antagonist naloxone hydrochloride may be administered to counteract significant respiratory depression if it occurs.

6.3. Shelf life

4 years.

6.4. Special precautions for storage

Do not store above 25°C.

Store in the original container in order to protect from light.

6.5. Nature and contents of container

Polypropylene tablets containers with tamper evident polyethylene caps.

Pack size: 100 tablets.

6.6. Special precautions for disposal and other handling

No special requirements.

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