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Aspirin 300mg Soluble Tablets

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Boots Soluble Aspirin Tablets or Dispersible Aspirin Tablets BP 300mg or Soluble Aspirin Tablets 300mg or Boots Aspirin 300mg    Soluble Tablets

2.    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Active ingredient    mg/tablet

Aspirin    300

3.    PHARMACEUTICAL FORM

Tablet

4.    CLINICAL PARTICULARS

4.1    Therapeutic Indications

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

For oral administration.

4.2    Posology and Method of Administration

Adults and children over 16 years: One to three tablets.

Stir the tablets in a little water until dispersed immediately before use.

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

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

Elderly: There is no need for dosage reduction in the elderly.

4.3 Contra-Indications

A history of, or active peptic ulceration. Haemophilia or other clotting disorders, gout, asthma, angiodema, urticaria, rhinitis or other evidence of hypersensitivity to aspirin or non steroidal antiinflammatory drugs. Aspirin should be avoided in severe renal or hepatic impairment.

4.4 Special Warnings and Special Precautions for Use

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, unless specifically indicated (e.g. 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 of uricosurics.

4.6 Pregnancy and Lactation

Use during pregnancy, particularly of chronic or intermittent high doses should be avoided. Use in the third trimester should be avoided since 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.

Aspirin should be avoided during lactation because of the possible risk of Reye’s syndrome. Regular use of high doses could impair platelet function and produce hypoprothrombinaemia in infants, if neonatal vitamin K stores are low.

Aspirin may displace bilirubin from plasma albumin and may lead to kernicterus in jaundiced neonates.

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 (2.5 mmol/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.

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 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.

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 salicyluric acid, salicyl phenolic glucuronide, salicylic acyl glucuronide, gentisic acid and gentisuric acid. The formation of the major metabolites, salicyluric acid and salicyl phenolic glucuronide is easily saturated and follows michaelis-menten kinetics; the other metabolic routes are first-order processes. As a result, steady-state plasma-salicylate concentrations increase disproportionately with dose. Following a 325-mg aspirin dose, elimination is a first order process and the plasma salicylate halflife is about 2 to 3 hours; at high aspirin doses, the half-life increases to 15 to

30 hours. Salicylate is also excreted unchanged in the urine; the amount excreted by this route increases with increasing dose and also depends on urinary pH, about 30% of a dose being excreted in alkaline urine compared with 2% of a dose in acidic urine. Renal excretion involves glomerular filtration, active renal tubular secretion and passive tubular reabsorption.

5.3. Pre-clinical Safety Data

None stated.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Dried maize starch powder Sodium lauryl sulphate Lactose

Sodium saccharin recryst (76% sacc)

Anhydrous citric acid pdr

Anhydrous citric acid gran

Calcium carbonate

Povidone

Isopropyl alcohol

Purified water

6.2. Incompatibilities

None stated.

6.3. Shelf life

Amber glass bottle: 36 months Cold form blister: 36 months Opaque blister: 24 months White HDPE bottle: 24 months

6.4.


Special precautions for storage

None.

6.5. Nature and contents of container

1.    Amber glass bottle with tinplate screw cap having a waxed aluminium faced liner. Pack size: 500

2.    A child resistant push through pack of opaque 250 micron PVC/40gsm PVdC blisters heat sealed to 35gsm Glassine paper/9micron soft temper aluminium foil.

Pack sizes: 6 / 8 / 10 / 12 / 16 / 18 / 20 / 24 / 25 / 30 / 32 / 36 / 48 / 96 / l00.

3.    White HDPE bottle with a polypropylene cap fitted with an induction heat seal membrane containing 100 or 500 tablets.

Pack sizes: 30 / 32 / 36 / 50 / l00 / 500

4.    Aluminium/polyethylene laminate strip pack.

Pack size: 24

5.    An amber-coloured glass bottle with a polyethylene or polypropylene child-resistant cap having a waxed aluminium-faced pulpboard or lectraseal liner. Pack sizes: 30 / 32 / 36 / 50 / 100

6.6. Instructions for use and handling

Not applicable.

7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

8. MARKETING AUTHORISATION NUMBER

PL 00014/5031R

9.    DATE OF FIRST AUTHORISATION / RENEWAL OF THE

AUTHORISATION

12 October 1981 / 12 October 1991

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DATE OF REVISION OF THE TEXT

07/05/2010