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Introduction

Paracetamol relieves pain and fever in adults and children, and is the most widely accepted medicine in the UK for this purpose. It is used mainly for its pain relief properties either as a medicine prescribed by a doctor or it can be purchased as an over-the-counter (OTC) medicine both in retail pharmacies or grocers' shops. When sold in pharmacies pack sizes are limited to a maximum of 32 tablets, and in shops other than pharmacies pack sizes are limited to a maximum of 16 tablets. Multiple packs can be purchased provided the total does not exceed 100 tablets. For quantities of more than 100 tablets a doctor's prescription is necessary. These limitations do not apply to products in the form of liquids, effervescent tablets or powders.

In addition to these statutory requirements, the Royal Pharmaceutical Society of Great Britain (RPSGB) has advised pharmacists that they should restrict sales of paracetamol to one pack of 32 tablets per sale unless there are 'justifiable circumstances' for selling more than one pack. The RPSGB has not defined what constitutes 'justifiable circumstances'.

There are virtually no groups of people who should not take paracetamol, and interactions with other treatments are rarely a problem.

When taken at the recommended dosage, there are virtually no side-effects.

Dosage

The recommended adult dose of paracetamol is two 500 mg tablets, with four hours between doses, and no more than eight tablets in 24 hours.

If this recommended dose is adhered to, there will be no toxic effects, even in prolonged or habitual use. Paracetamol does not accumulate in the body following normal doses. It is not absorbed any more rapidly or slowly than other highly popular pain relieving medicines and does not leave the stomach at a different rate.

Overdose

In substantial overdose liver damage is likely to occur assuming the patient does not receive treatment.

There is an antidote to paracetamol overdose and provided it is given within 12 hours, a complete recovery can be made. The antidote is often useful beyond 12 hours, showing benefit up to 48 hours after overdosing. Most medicines other than paracetamol, when taken in fatal overdose, bring about death in 12-18 hours.

Publicity has been given to death by 'accidental' overdose. It is difficult to see how a person can take a dose of paracetamol that is sufficient to be fatal without being aware of it. Indeed, research with patients who have overdosed shows that overdoses are taken deliberately, and in a majority death was the intended outcome. In a proportion, although the overdose was deliberate, induced illness or self harm rather than death was the intended outcome.

When press reports of death brought about by small numbers of paracetamol tablets are investigated, and autopsy reports checked, invariably it becomes apparent that either much larger doses of paracetamol were taken or other medicines were taken and were the primary cause of death. Reports given to the press at the time of inquest, by family and friends may, quite understandably, be not entirely accurate or reliable.

Labelling

All proprietary medicines containing paracetamol are comprehensively labelled. They have to be by law. They have information that they contain paracetamol, how much, and the recommended dose. They all contain the statements 'Do not exceed the stated dose' and 'Immediate medical advice should be sought in the event of an overdose, even if you feel well'.

Safe use of medicines

An independent survey carried out by the British Market Research Bureau in 1987, showed that 97% of respondents read the instructions carefully before using a medicine for the first time, 94% take medicine only when absolutely necessary, and 95% exercise care in the use of non-prescription medicines; 86% strongly disagreed with the statement that it is perfectly safe to take as many as you wish of non-prescription medicines.

The survey also showed that 85% of people use just one OTC product for an illness. It is clear that the British population is inclined to be cautious in their approach to the use of medication generally.

Approximately 30 million people each year use paracetamol safely and properly.