1. Name Of The Medicinal Product
Dispersible Aspirin Tablets BP 75mg.
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Tablets
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 75-150mg once daily. In some circumstances a higher dose may be appropriate , especially in the short term, and up to 300mg 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 antiinflammatory 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 aspirin should not be given to children aged under 16 years 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).
4.6 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 >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.
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 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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Aspirin has analgesic, antipyretic and antiinflammatory 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 400mg was taken within 8 hours before or within 30 minutes after immediate release aspirin (81mg), 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.
5.2 Pharmacokinetic Properties
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 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
6.2 Incompatibilities
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
25μm Aluminium foil/33μm 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 And Other Handling
Not applicable.
7. Marketing Authorisation Holder
The Boots Company PLC
Nottingham
NG2 3AA
Trading as
BCM
8. Marketing Authorisation Number(S)
PL 00014/5322R.
9. Date Of First Authorisation/Renewal Of The Authorisation
First Authorisation: 22 September 1981.
Last renewal: 24 July 1997.
10. Date Of Revision Of The Text
November 2008
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