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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Boots 75mg Soluble Aspirin Tablets or Dispersible Aspirin Tablets BP 75mg or Boots Aspirin 75mg Dispersible Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient Aspirin EP 75.0 mg/tablet

3    PHARMACEUTICAL FORM

Dispersible Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery.

4.2    Posology and method of administration

The advice of a doctor should be sought before commencing therapy for the first time. The usual dose, for long term use, is 75-150 mg once daily. In some circumstances a higher dose may be appropriate, especially in the short term, and up to 300 mg a day may be used on the advice of a doctor.

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

For oral administration.

4.3 Contraindications

A history of, or active peptic ulceration, haemophilia or other clotting disorders. Asthma, urticaria, rhinitis or other evidence of hypersensitivity to aspirin or non steroidal anti-inflammatory drugs.

4.4 Special warnings and precautions for use

Before commencing long-term aspirin therapy for the management of cardiovascular or cerebrovascular disease, patients should consult their doctor who can advise on the relative benefits of aspirin versus the risks for the individual patient.

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 it should not be given to children under 16 years of age unless specifically indicated (e.g. for Kawasaki’s disease).

Keep all medicines out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

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 action uricosurics.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

Pregnancy and lactation

The use of analgesic doses of aspirin during pregnancy, particularly during the third trimester, should be avoided. The drug may affect maternal and newborn 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. The use of low doses of aspirin, for the secondary prevention of myocardial infarction and stroke are probably not harmful.

Aspirin is secreted into breast milk in low concentration and should therefore be avoided during lactation because of the possible risk of Reye's Syndrome and the fact that high doses could potentially impair platelet function.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Dyspepsia, nausea and vomiting. Less commonly irritation of the gastrointestinal mucosa may lead to erosion, ulceration and gastrointestinal bleeding. Hypersensitivity reactions including urticaria, rhinitis, angioneurotic oedema and severe bronchospasm.

4.9 Overdose

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

Symptoms

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.

Management

Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/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 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 >700 mg/L (5.1 mmol/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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

Aspirin also inhibits platelet aggregation by irreversible acetylation of platelet cyclooxygenase.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after immediate release aspirin (81 mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

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 1520 minutes) as plasma salicylate concentrations increase.

Salicylate is mainly eliminated by 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.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Dried Maize starch powder Sodium lauryl sulphate Lactose

Sodium saccharin

Anhydrous citric acid

Calcium carbonate

Povidone

Isopropyl alcohol

Lactose - Starch basic granules

Not applicable.

6.3    Shelf life

Blister pack and amber glass bottle - 36 months. HDPE bottle - 24 months.

6.4    Special precautions for storage

None.

6.5 Nature and contents of container

25pm Aluminium foil/33pm polythene laminate strip pack. Three strips of eight tablets in a carton.

Pack size: 24.

or

Rectangular amber-glass bottle with a polythene child resistant cap fitted with a lectraseal tamper-evident liner which is: surlyn/aluminium foil/polythene/bleached kraft paper/dot adhered to Melinex coated carton board.

Pack size: 100.

or

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

Pack size: 16, 28, 30, 32, 50, 100.

6.6 Special precautions for disposal

Not applicable.