Aspirin and Codeine Tablets BP

Tablet

For the relief of headache, migraine, neuralgia, toothache, period pain, rheumatic pains and symptoms of colds and influenza.

For oral administration.

Adults and children over 16 years: 1 to 2 tablets.

This dose may be taken, up to 4 times a day at intervals of not less than 4 hours.

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

Elderly: The normal adult dose is still appropriate in the elderly.

Do not take for more than 3 days continuously without medical review.

Hypersensitivity to any of the ingredients. Active peptic ulceration or a history of ulceration, haemophilia or other clotting disorders. Gout, asthma, urticaria, angiodema, rhinitis or other evidence of hypersensitivity to aspirin.

Aspirin should be avoided in patients with severe renal or hepatic impairment.

Obstructive airways disease, respiratory depression, acute alcoholism, where there is as risk of paralytic ileus, head injuries and conditions in which intracranial pressure is raised. Breast feeding.

If symptoms persist consult your doctor.

There is a possible association 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).

Codeine should be taken with caution or in reduced doses by patients with hypotension, decreased respiratory reserve, convulsive disorders, hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy, shock, inflammatory or obstructive bowel disorders and myasthenia gravis.

Aspirin and other NSAIDs may cause salt and water retention and renal failure especially in patients with pre-existing renal impairment. Aspirin should be used with caution by patients with asthma, allergic disease, dehydration, glucose-6-phosphate dehydrogenase deficiency and the elderly.

Keep all medicines out of the reach of children.

The Leaflet will state in a prominent position in the '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 the tablets.

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

The Label will state (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.

Alcohol and corticosteroids may enhance the effects of aspirin on the gastrointestinal tract. Aspirin may enhance the effects of coumarin anticoagulants and oral hypoglycaemics of the sulphonylurea type. The toxicity of methotrexate may be enhanced by concomitant use of aspirin. Aspirin diminishes the uricosuric action of probenecid and sulphinpyrazone.

Codeine may delay the absorption of mexiletine and thus reduce the antiarrhythmic effect of the latter. The depressant effects of codeine are enhanced by depressants of the central nervous system such as hypnotics, sedatives, tricyclic antidepressants and phenothiazines. Codeine may antagonise the gastrointestinal effects of metoclopramide and domperidone.

The safety of aspirin and codeine tablets during pregnancy has not been established and use in this period should be avoided. The use of aspirin during pregnancy, particularly during the third trimester, should be avoided since the drug may affect maternal and new born haemostatic mechanisms, leading to an increased risk of haemorrhage. Aspirin may also delay the onset and increase the duration of labour. With high doses, there may be premature closure of the ductus arteriosus, leading possibly to persistent pulmonary hypertension. In addition, codeine during pregnancy has been associated with respiratory and heart malformations.

Although both aspirin and codeine are secreted into breast milk in low concentrations, use of aspirin and codeine tablets should be avoided during lactation because of the risk of Reye's syndrome and the fact that high doses of aspirin could potentially impair platelet function.

May cause drowsiness and therefore may influence the ability to drive and operate machinery.

Dyspepsia, nausea, vomiting, constipation, increased bleeding time, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, tachycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, miosis, respiratory depression, difficulty in micturition and possibly ureteric or biliary spasm, headache, hallucinations, dysphoria, decreased libido or potency, pruritis. Less commonly irritation of the gastrointestinal mucosa may lead to erosion, ulceration, gastrointestinal bleeding. Hepatotoxicity which occurs rarely.

Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions including urticaria, rhinitis and angioneurotic oedema in susceptible individuals.

Aspirin may also cause salt and water retention as well as deterioration in renal function (see also section 4.4).

Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.

Prolonged use of a painkiller for headaches can make them worse.

Salicylate poisoning is usually associated with plasma concentrations >350mg/L (2.5mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1mmol/L). Single doses less than 100mg/kg are unlikely to cause serious poisoning.

Common features of salicylate poisoning include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.

A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of 4 years. In children aged 4 years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.

Uncommon features of salicylate poisoning include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.

Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.

Give activated charcoal if an adult presents within one hour of ingestion of more than 250mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate.

The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.

Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700mg/L (5.1mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

The effects of codeine in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350mg or a child more than 5mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least 4 hours after ingestion.

Aspirin has analgesic, antipyretic and anti-inflammatory actions which are considered to be due to inhibition of the synthesis of prostaglandins.

Codeine phosphate is an opioid analgesic which acts via the central nervous system.

Absorption of non-ionised aspirin occurs in the stomach and intestine. Some aspirin is hydrolysed to salicylate in the gut wall. After absorption aspirin is rapidly converted to salicylate but during the first 20 minutes following oral administration, aspirin is the predominant form of the drug in the plasma. Aspirin is bound to plasma proteins and is widely distributed. Plasma aspirin concentrations decline rapidly (half life 15-20 minutes) as plasma salicylate concentrations increase.

Salicylate is mainly eliminated by the hepatic metabolism the metabolites including salicylic acid, salicyl phenolic glucuronide, salicylic acyl glucuronide, gentisic acid and gentisuric acid. As a result of zero order kinetics, plasma steady state salicylate concentrations increase disproportionately with dose. Salicylate is also excreted unchanged in the urine to an extent which depends on the dosage and urinary pH. Renal excretion involves glomerular filtration, active renal tubular secretion and passive tubular reabsorption.

Codeine phosphate is absorbed from the gastrointestinal tract and peak plasma concentrations occur after about one hour. Codeine is metabolised by O- and N-Demethylation in the liver to morphine and norcodeine. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid. The plasma half life has been reported to be between 3 and 4 hours.

Not applicable.

Specially Dried Maize Starch EP.

Sodium Metabisulphite BP.

None known.

36 months: For glass bottle

24 months: For HDPE bottle

None.

Amber glass bottle with a child-resistant polythene/polypropylene cap, fitted with a lectraseal tamper-evident liner which is: surlyn/aluminium foil/polythene/bleached kraft paper/dot adhered to melinex coated carton board or a child-resistant polyethylene/polypropylene cap fitted with a waxed aluminium faced pulpboard liner.

Pack sizes: 24, 25, 30, 32, 36, 48, 50, 100.

or

A white HDPE bottle with a polypropylene cap fitted with an induction heat seal membrane.

Pack sizes: 24, 25, 30, 32, 36, 48, 50, 100.

None

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

PL 00014/0155R

Date first authorisation: 13 April 1981

Date most recent renewal granted: 13 April 1991

August 2005