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1. Co-Codaprin Aspirin And Codeine Tablets
2. Co-Codaprin Aspirin And Codeine Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Co-Codaprin Aspirin & Codeine Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Aspirin    400.0mg

Codeine Phosphate    8.0mg

3 PHARMACEUTICAL FORM

Oral Tablet

4.1 Therapeutic indications

For relief of pain in headaches and menstruation and the symptomatic relief of colds, flu and feverishness.

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

4.2 Posology and method of administration

Route of administration: Oral

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.

Adults and the Elderly

One to two tablets every three or four hours - Maximum daily dose 10 tablets.

Paediatric Population

Children aged 16 years to 18 years

One to two tablets every six hours. Maximum daily dose 8 tablets.

Children aged less than 16 years

Children (under 16 years): Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).

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)

4.3    Contraindications

Patients who are prone to dyspepsia or lesions of the gastric mucosa. Patients with haemophilia. Patients with an intolerance to aspirin - especially aspirin sensitive asthmatics. Children under 16 years. Respiratory depression. Aspirin is contraindicated in patients with active peptic ulceration or a history of peptic ulceration.

In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions(see section 4.4).

In women during breastfeeding (see section 4.6)

In patients for whom it is known that they are CYP2D6 ultra-rapid metabolisers.

4.4    Special warnings and precautions for use CYP2D6 metabolism

Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained.

Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opiod toxicity even at common prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.

General symptoms of opiod toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression which may be life-threatening and very rarely fatal.

Estimates of prevalence of ultra-rapid metabolisers in different populations are summarised below:

Population	Prevalence %
Afri can/Ethi opi an	29%
African American	3.4% to 6.5%
Asian	1.2% to 2%
Caucasian	3.6% to 6.5%
Greek	6.0%
Hungarian	1.9%
Northern European	1% - 2%

Post-operative use in children

There have been reports in the published literature that codeine given postoperatively in children after tonsillectomy and /or adenoidectomy for obstructive sleep apnoea, led to rare, but life-threatening adverse events including death (see also section 4.3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.

Children with compromised respiratory function

Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.

If symptoms persist for more than 3 days, consult your doctor.

Do not take if you have a stomach ulcer.

Do not exceed the stated dose.

There is a possible link between Aspirin and Reye’s Syndrome when given to children. Reye’s Syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason aspirin should not be given to children aged under 16 years unless specifically indicated (e.g. for Kawasaki’s disease).

Patient Information Leaflet (in ’before taking’ section)

•    If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or healthcare professional.

•    Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the tablets.

•    Taking a painkiller for headaches too often or for too long can make them worse.

Packaging (to be displayed prominently on outer pack - not boxed).

•    If you need to use this medicine for more than three days at a time, see your doctor or pharmacist. Taking codeine regularly for a long time can lead to addiction.

•    Taking a painkiller for headaches too often or for too long can make them worse.

4.5 Interaction with other medicinal products and other forms of interaction

Metoclopramide - antagonistic effect.

Mexiletine - delayed absorption.

Heparin, phenindione, warfarin and other coumarins - potentiation of effect.

Methotrexate - delayed excretion - increased toxicity.

Probenecid and Sulphinpyrazone - inhibition. Alcohol - potentiation of depressant effect.

4.6    Fertility,Pregnancy and lactation

Codeine should not be used during breastfeeding (see section 4.3)

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant. However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opiod toxicity in the infant, which may be fatal.

4.7    Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Gastro-intestinal disturbances such as nausea, dyspepsia, vomiting and constipation. Irritation of the gastric mucosa with erosion, ulceration and haematemesis may occur. Slight blood loss may occur in about 70% of patients - it is not of clinical significance. Aspirin increases the bleeding time and decreases platelet adhesiveness. May cause drowsiness and confusion. Micturation may be difficult and there may be uteric or bilary spasm. There may be an antidiuretic effect. Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions in susceptible individuals.

Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when the treatment is stopped. Prolonged use of a painkiller for headaches can make them worse.

4.9 Overdose

Severe intoxication include hyperventilation, fever, restlessness, ketosis and respiratory alkalosis and metabolic acidosis. Depression of the CNS may lead to coma, cardiovascular collapse and respiratory failure.

Treatment

Empty stomach by aspiration and lavage. Patients with mild intoxication should be encouraged to drink plenty of fluids. In severe cases forced alkaline diuresis may be required. Plasma electrolytes should be monitored regularly. Intensive support therapy to correct respiratory failure and shock. The specific antagonist naloxone hydrochloride may be used (400pg I.V. at 2-3 minute intervals or 50-100pg/kg body weight).

5.1    Pharmacodynamic properties

Analgesic, antipyretic.

Codeine is a centrally acting weak analgesic. Codeine exerts it effect through p opiod 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.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Starch

Talc

6.2    Incompatibilities

None stated

6.3    Shelf life

3 years

6.4    Special precautions for storage

To be protected from light.

6.5 Nature and contents of container

Amber glass round bottle with polypropylene child resistant wadded cap containing 25 tablets.

6.6 Special precautions for disposal

Not applicable