Aspirin Tablets Bp 300mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aspirin Tablets BP 300 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active Ingredient: Aspirin BP 300.00 mg/tablet
3 PHARMACEUTICAL FORM
Plain white uncoated biconvex tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Anti-inflammatory:
Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness.
Analgesic and anti-pyretic:
Mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains.
4.2 Posology and method of administration
Adults, the elderly and children over 16 years: Usual single dose 300-1000 mg.
Maximum daily dose 4g in divided dose.
Dosage:
2 to 3 tablets every 4 to 6 hours with a maximum of 4 doses (12 tablets).
Do not give to children aged 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).
4.3 Contraindications
Known intolerance to Aspirin or any of the other ingredients in the tablet.
Known hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to aspirin or non-steroidal antinflammatory drugs.
Aspirin is contraindicated in patients with active peptic ulceration or a history of peptic ulceration and those with haemophilia, other clotting disorders or gout.
Aspirin should not be taken concurrently with anti-coagulants.
4.4 Special warnings and precautions for use
• Caution should be exercised in patients with asthma, allergic disease, impairment of hepatic or renal function (avoid if severe) and dehydration.
• Do not take if you have a stomach ulcer.
• If symptoms persist for more than three days consult your doctor.
• Medicines should not be taken in pregnancy without consulting your doctor.
• Keep out of reach of children.
• 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 under 16 years, unless specifically indicated (e.g. for Kawaski’s disease).
• Should be avoided in late pregnancy and during breast feeding (see section 4.6).
Aspirin Tablets 300 mg contain lactose. Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
• May enhance the effects of anticoagulants, and oral hypoglycaemic agents.
• May enhance the effects of antiepileptics such as phenytoin and sodium valproate
• May enhance the effects of insulin and sulphonylureas
• The activity of methotrexate may be markedly enhanced and its toxicity increased.
• May inhibit action of uricosurics.
• The toxicity of sulphonamides may also be increased.
• Adversely affects the action of some diuretics and probenecid
• May potentiate the action of heparin, phenindione.
• May potentiate the effects and side effects of other non-steroidal anti inflammatory drugs and enhance the effects of digoxin.
• Concurrent use of alcohol and corticosteroids may enhance the effects of aspirin on the gastrointestinal tract.
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 extrapolations 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 Fertility, Pregnancy and lactation
Aspirin is best avoided in late pregnancy, as it may prolong labour and cause bleeding in the neonate.
High doses of aspirin may result in closure of foetal ductus arteriosus in utero and possibly persistent pulmonary hypertension in the new born.
Kernicterus may be a consequence of jaundice in neonates.
Aspirin should be avoided during lactation, as there is a risk of Reye’s syndrome.
Regular use of high doses could impair platelet function and produce hypoprothrombinaemia in the infant if neonatal vitamin K stores are low.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Side effects are not common and are mainly gastrointestinal e.g. dyspepsia, nausea, vomiting, diarrhoea and gastrointestinal bleeding which can lead to anaemia in some cases. Gastrointestinal ulcers may develop, which may lead to haemorrhage and perforation.
Aspirin may precipitate bronchospasm, and induce attacks of asthma in susceptible subjects; it may induce gastrointestinal haemorrhage, occasionally major.
Due to the effect on platelet aggregation, aspirin may be associated with an increased risk of bleeding.
Isolated cases of liver function disturbances and skin reactions have been reported Aspirin and other NSAIDS may cause salt and water retention as well as a deterioration of renal function.
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.
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, thrombocytopenia, 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 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, 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 >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 is an analgesic and antipyretic with anti-inflammatory properties. Aspirin inhibits prostaglandin synthetase.
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.
5.2 Pharmacokinetic properties
Absorption:
Aspirin is rapidly absorbed after oral administration, with some hydrolysis to salicylate before absorption. Absorption is delayed by the presence of food and is impaired in patients suffering migraine attacks. Absorption is more rapid in patients with achlorhydria and also following administration by polysorbates and antacids.
Blood Concentration:
Peak plasma concentrations of approximately 45 mcg/ml are attained 1 to 2 hours after an oral dose of 650 mg but stabilise at approximately 270 mcg/ml after oral doses of 3 g daily. After an oral dose of about 2 g, peak plasma concentrations of approximately 15 mcg/ml of aspirin are attained in about one hour and peak plasma concentrations of approximaely 130 mcg/ml of salicylate are attained in 2-4 hours.
Half-Life:
Plasma / Aspirin: approximately 17 minutes Plasma / Salicylate:
Low Doses: 2-3 hours
High Doses: up to 19 hours.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose, starch
6.2 Incompatibilities
None stated.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original container.
Keep the container tightly closed.
6.5 Nature and contents of container
The product is available in packs of 25, 50, 100, 500, and 1000 tablets in securitainers and tampertainers. The container is made up of high density polypropylene body and low density polyethylene cap.
The product is also available in blister packs of 16 or 20 tablets.
Blister pack specification:
250 micron UPVC coated with 40 gsm PVDC
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20 micron aluminium foil coated with H66 Universal Lacquer
MARKETING AUTHORISATION HOLDER
Bristol Laboratories Ltd Unit 3, Canalside,
Northbridge Road,
Berkhamsted,
Hertfordshire HP4 1EG United Kingdom
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