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ASPIRIN CAPLETS 300MG

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Aspirin Caplets 300 mg or Aspirin Tablets 300 mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Aspirin BP Gran Ph Eur Aspirin BP Cryst Ph Eur Quantity 180.0mg 120.0mg

3.

PHARMACEUTICAL FORM Tablet

4. 4.1.

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

4.2.

Posology and method of administration Adults and children over 16 years: One to three tablets. 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 aged under 16 years, unless specifically indicated (e.g. Kawasakis disease). Elderly: There is no need for dosage reduction in the elderly. For oral administration.

4.3.

Contra-indications

A history of, or active peptic ulceration, haemophilia or other clotting disorders, gout, asthma, urticaria, rhinitis or other evidence of hypersensitivity to aspirin or non steroidal anti-inflammatory drugs. Aspirin should be avoided in patients with severe renal or hepatic impairment. Breast feeding.

4.4.

Special warnings and special precautions for use If symptoms persist consult your doctor. There is a possible association between aspirin and Reyes Syndrome when given to children. Reyes 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. Kawasakis disease). Aspirin and other NSAIDs may cause salt and water retention and renal failure especially in patients with pre-existing renal impairment. Do not exceed the stated dose. Keep all medicines out of the reach of children.

4.5.

Interactions 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 anticoagulant 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 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.

Aspirin is secreted into breast milk in low concentration and should therefore be avoided during lactation because of the possible risk of Reyes 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. vomiting. Less commonly irritation of the gastrointestinal mucosa may lead to erosion, ulceration and gastrointestinal bleeding. Hepatotoxicity which occurs rarely. Hypersensitivity reactions including urticaria, rhinitis, angio neurotic oedema and severe bronchospasm. Aspirin may cause salt and water retention as well as deterioration of renal function (see also section 4.4).

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 700mg/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 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. 5.1.

PHARMACOLOGICAL PROPERTIES 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 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.

Pre-clinical safety data None stated.

6. 6.1.

PHARMACEUTICAL PARTICULARS List of excipients Maize starch powder.

6.2.

Incompatibilities None stated.

6.3.

Shelf life Glass bottle: PVC/PVdC blister: PVC blister: HDPE bottle: 36 months 36 months 36 months 36 months

6.4.

Special precautions for storage Glass bottle: PVC/PVdC Blister: PVC Blister: HDPB bottle: None. Store in a dry place below 25C. Do not store above 25C. None.

6.5.

Nature and content of container

An amber coloured glass bottle with a polythene/polypropylene child resistant cap having a waxed aluminium pulpboard liner or a child resistant polyethylene/polypropylene cap with a tamper evident heat-sealed liner of surlyn/aluminium or aluminium/polyethylene. Pack sizes: 30, 32, 36, 50, 100 or A 250-ml amber coloured glass bottle with a tin-plate cap having a waxed pulpboard liner. Pack size: 500 or A child-resisitant push through opaque 250 micron PVC/40gsm PVdC blisters heat-sealed to 35gsm Glassine paper/9 micron soft temper aluminium foil. Pack sizes: 6, 8,10, 12, 16, 18, 20, 24, 25, 30, 32, 36, 48, 96, 100 A child-resisitant push through pack of opaque 250 micron PVC blisters, heat sealed to 35gsm Glassine paper/9 micron soft temper aluminium foil. Pack sizes: 6, 8, 10, 12, 16, 18, 20, 24, 25, 30, 32, 36, 48, 96, 100 or A white HDPE bottle with a polypropylene cap fitted with an induction heat seal membrane. Pack sizes: 30, 32, 36, 50, 100, 500.

6.6.

Instructions for use, handling and disposal None.

7.

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

8.

MARKETING AUTHORISATION NUMBER PL 00014/0584

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION 4 July 1997

10

DATE OF REVISION OF THE TEXT
23/11/2005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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