Reckitt Benckiser Ireland Limited

Disprin Original 300mg Dispersible Tablets.

Each tablet contains 300 mg of acetylsalicylic acid.

For a full list of excipients, see section 6.1.

Dispersible tablets (tablets).

White, flat, circular, bevel-edged dispersible tablets with the ' Sword' motif and the word ' Disprin' engraved on one face, plain on reverse.

For the relief of mild to moderate pain, such as is associated with headache, toothache, neuralgia and period pains.

Symptomatic relief in upper respiratory tract infections (such as feverishness, cold and flu, sore throat).

Reduction of inflammation, such as in lumbago.

Oral administration after dissolution in water.

Adults and children aged 16 and over: One to two tablets every 4 hours. Do not exceed 12 tablets in 24 hours.

Do not give to children and adolescents aged under 16 years, except on medical advice, where the benefit outweighs the risk.

Elderly: Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. (See also Section 4.4).

Should not be given to patients hypersensitive (e.g. bronchospasm, rhinitis, urticaria) to aspirin or to other non-steroidal anti-inflammatory drugs. Do not use in patients suffering from active peptic ulceration or a coagulation deficiency disorder.

Elderly patients are particularly susceptible to the adverse effects of non-steroidal anti-inflammatory drugs. Unsupervised prolonged use of non-steroidal anti-inflammatory drugs in the elderly is not recommended.

This product should be taken only when necessary.

Prolonged use except under medical supervision can be harmful.

Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration.

The doctor should be consulted if there is no improvement in 24 hours.

If the patient is on any medication consult the doctor or pharmacist before using.

If the patient suffers from asthma, has renal or hepatic impairment, or a history of peptic ulceration or inflammatory bowel disease, then a doctor should be consulted before taking the product.

There is 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 and adolescents aged under 16 years unless specifically indicated.

It is considered unsafe to take non-steroidal anti-inflammatory drugs in combination with warfarin or heparin unless under direct medical supervision.

Aspirin may enhance the effects of anticoagulants, inhibit the effects of uricosurics and reduce the excretion of methotrexate (increasing its toxicity).

Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of non-steroidal anti-inflammatory drugs.

Other non-steroidals: Avoid concomitant use of two or more non-steroidal anti-inflammatory drugs.

Corticosteroids: Increased risk of gastrointestinal bleeding.

Antihypertensives: Reduced antihypertensive effect.

Oral hypoglycaemic agents: Inhibition of metabolism of sulfonylurea drugs, prolonged half-life and increased risk of hypoglycaemia.

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.

Lithium: Decreased elimination of lithium.

Methotrexate: Decreased elimination of methotrexate.

Cyclosporin: Increased risk of nephrotoxicity with NSAIDs.

Aminoglycosides: Reduction in renal function in susceptible individuals, decreased elimination of aminoglycoside and increased plasma concentrations.

Probenecid: Reduction in metabolism and elimination of NSAID and metabolites.

Sodium valproate: Aspirin may enhance its effects.

As with all other drugs, aspirin should be taken under pregnancy only after strict risk-benefit evaluation.

In the last three months of pregnancy, the prolonged administration of aspirin >300 mg/day) can lead to delayed onset and increased duration of labour, premature closure of the ductus arteriosus and inhibition of uterine contractions. An increased haemorrhagic tendency has been observed in both the mother and child. Administration of aspirin in high doses shortly before birth can lead to intracranial haemorrhages, particularly in premature babies.

Salicylates pass into breast milk in small quantities. As no adverse effects on the infant have been observed after occasional use, interruption of breast feeding is usually unnecessary. However, if high doses >300 mg/day) are used regularly, breast feeding should be discontinued as toxicity to the new-born cannot be ruled out.

Not known.

Non-steroidal anti-inflammatory drugs, including aspirin, may precipitate bronchospasm, rhinitis or urticaria or induce attacks of asthma in susceptible subjects.

Gastrointestinal disorders such as nausea, diarrhoea, vomiting and gastro-intestinal blood losses leading to anaemia have been reported with non-steroidal anti-inflammatory drugs such as aspirin. Gastrointestinal ulceration, perforation and major haemorrhage may also occur.

Isolated cases of liver (increased transaminases) and kidney dysfunction and severe skin reactions have been described.

Acute salicylate poisoning is usually manifested as hypokalaemia with metabolic acidosis and respiratory alkalosis. Nausea, vomiting, tinnitus, hyperpnoea, hyperpyrexia, confusion, disorientation, dizziness, coma and/or convulsions are common. Gastrointestinal haemorrhage is frequent. However, alkalaemia or acidaemia, alkaluria or aciduria, hyperglycaemia or hypoglycaemia, and water and electrolyte imbalances, can occur.

Chronic salicylate intoxication is commonly associated with daily headaches, nausea, tinnitus, dizziness, lethargy and confusion; coma may occur. The symptoms can mimic those resulting from illness for which the drug was given. Irritability, lethargy, delayed unresponsiveness and encephalopathy may be seen one to three days following withdrawal of aspirin. At the same time, the concentration of salicylate in the CNS may be high, with non-toxic values in the serum.

Serum salicylate levels above 3.6 mmol/l in adults (2.2 mmol/l in children) are likely to be toxic and levels of 5.4 mmol/l or above can be fatal.

Treatment: Fluid and electrolyte management is the mainstay of therapy; the immediate aim is to correct acidosis, hyperpyrexia, hypokalaemia and dehydration. Drug absorption can be arrested by induction of emesis or gastric lavage within an hour of ingestion. Drug excretion is enhanced by forced alkaline diuresis and by the early use of activated charcoal. Rarely, haemodialysis if necessary. Delayed encephalopathy may respond to the administration of mannitol.

Aspirin inhibits the cyclo-oxygenase enzyme involved in conversion of phospholipids to prostaglandins and its effects on the body are believed to result primarily from prevention of prostaglandin production. These effects include peripheral analgesia, fever reduction, reduction in inflammation and inhibition of platelet aggregation.

Aspirin is rapidly absorbed from the stomach and upper gastrointestinal tract with peak levels after around 20-30 minutes following dissolution. It is subject to first-pass metabolism with an overall bioavailability of around 70%. Metabolism is by conversion to salicylic acid and then by further conversion to other metabolites. These are excreted by the kidneys in both free and conjugated form. The plasma half-life of aspirin is around 15-20 minutes and that of salicylic acid is 2-3 hours.

No preclinical findings of relevance have been reported.

Calcium carbonate (E170)

Maize starch

Citric acid anhydrous

Talc (E553b)

Sodium laurilsulfate

Saccharin (E954)

Crospovidone

Lime flavour 2

Not applicable.

Three years.

Store below 25°C. Store in the original container in order to protect from light.

Strips of aluminium foil in cartons containing 12, 24 and 48 tablets.

Not all pack sizes may be marketed.

No special requirements.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/6/1.

Date of first authorisation: 1st April, 1978

Date of last renewal: 1st April, 2008

June 2008