Aspirin Tablets Bp 300mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dispersible Aspirin Tablets BP 300mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains aspirin BP 300mg.
3 PHARMACEUTICAL FORM
Dispersible tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness. For mild to moderate pain, including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains. For the symptomatic relief of influenza, feverishness and feverish colds.
4.2 Posology and method of administration
For all indications:
Adults and elderly patients:
1 to 3 tablets every 4 hours, if necessary, up to a maximum of 12 tablets a day. Children:
Do not give to children under 16 years unless specifically indicated (e.g. for Kawasakis’s disease). (See 4.4 Special warnings and special precautions for use).
Method of administration: Dispersible Aspirin Tablets should be dissolved in a glass of water and taken orally.
4.3 Contraindications
Due to the increased risk of Reye’s syndrome, aspirin is not recommended in children under 16 years of age unless specifically indicated (e.g. for Kawasaki's disease).
Other contraindications include active peptic ulceration or a history of peptic ulceration, gout, breast feeding, haemophilia, concurrent anticoagulant therapy, hypersensitivity to acetylsalicylic acid and other NSAIDs, haemorrhagic disease, and severe renal or hepatic impairment.
4.4 Special warnings and precautions for use
Administer with caution in the presence of allergic disease, renal or hepatic impairment, or dehydration. Acetylsalicylic acid may trigger haemolysis in patients with glucose-6-phosphate dehydrogenase deficiency.
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).
Elderly patients may be more susceptible to the toxic effects of salicylates.
Before commencing long-term therapy for the management of cardiovascular or cerebrovascular disease patients should consult their doctor who can advise on the relative benefits versus the risks for the individual patient.
Aspirin may also precipitate bronchospasm or induce attacks of asthma in susceptible subjects.
Continuous prolonged use of aspirin should be avoided in the elderly because of the risk of gastrointestinal bleeding.
Aspirin may interfere with insulin and glucagon in diabetes.
Aspirin prolongs bleeding time, mainly by inhibiting platelet aggregation and therefore it should be discontinued several days before scheduled surgical procedures. Haematological & haemorrhagic effects can occur, and may be severe. Patients should report any unusual bleeding symptoms to their physician.
Salicylates should not be used in patients with a history of coagulation abnormalities as they may also induce gastro-intestinal haemorrhage, occasionally major. (see section 4.3)
Aspirin should not be taken by patients with a stomach ulcer or a history of stomach ulcers. (see section 4.3)
Patients with hypertension should be carefully monitored.
4.5 Interaction with other medicinal products and other forms of interaction
Anticoagulants: Aspirin may potentiate the effect of heparin and increases the risk of bleeding with oral anticoagulants, antiplatelet agents and fibrinolytics. Concomitant use is not recommended (see Section 4.3).
Other non-steroidal anti-inflammatory drugs (NSAIDs): Concurrent administration can increase side effects. Use of two or more NSAIDs increases risk of gastrointestinal haemorrhage. 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)
Corticosteroids: The risk of gastrointestinal bleeding and ulceration is increased. Corticosteroids reduce the plasma salicylate concentration and salicylate toxicity may occur following withdrawal of corticosteroids.
Carbonic anhydrase inhibitors: Reduced excretion of acetazolamide; salicylate intoxication has occurred in patients on high dose salicylate regimes and carbonic anhydrase inhibitors. Concurrent administration of carbonic anhydrase inhibitors such as acetazolamide and salicylates may result in severe acidosis and increased central nervous system toxicity.
Antacids and adsorbents: The excretion of aspirin is increased in alkaline urine; kaolin possibly reduces absorption. Patients should be advised against ingesting antacids simultaneously to avoid premature drug release.
Mifepristone: The manufacturer of mifepristone recommends that aspirin should be avoided until eight to twelve days after mifepristone has been discontinued.
Antimetabolites: The activity of methotrexate may be markedly enhanced and its toxicity increased.
Antibacterials: The toxicity of sulfonamides may be increased.
Alcohol: Some of the effects of aspirin on the gastrointestinal tract are enhanced by alcohol.
Antiemetics: Metoclopramide enhances the effects of aspirin by increasing the rate of absorption.
ACE inhibitors: Aspirin may reduce the antihypertensive effect of ACE inhibitors.
Anti-epileptics: May enhance the effects of phenytoin and sodium valproate.
Diuretics: Antagonism of the diuretic effect of spironolactone.
Hypoglycaemic agents: Aspirin may enhance the effects of insulin and oral hypoglycaemic agents.
Leukotriene antagonists: The plasma concentration of zafirlukst is increased.
Uricosurics: Effect of probenecid and sulfinpyrazone may be reduced.
Thyroid function tests: Aspirin may interfere with thyroid function tests.
4.6 Fertility, Pregnancy and lactation
Acetylsalicylic acid should not be taken during pregnancy, unless directed by a doctor. Do not administer at term or during lactation.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Side effects are generally mild and infrequent:
Blood and the lymphatic system disorders: Aspirin prolongs bleeding time, decreases platelet adhesiveness and, in large doses, may cause hypoprothrombinaemia. Thrombocytopenia may also occur. Bleeding disorders such as epistaxis, haematuria, purpura, ecchymoses, haemoptysis, gastrointestinal bleeding, haematoma and cerebral haemorrhage have occasionally been reported. Fatalities have occurred. Haemolytic anaemia can occur in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Immune system disorder: Hypersensitivity reactions include skin rashes, urticaria, angioedema, asthma, bronchospasm, rhinitis and rarely, anaphylaxis.
Ear & Labyrinth disorder: Tinnitus.
Gastrointestinal disorders: Gastrointestinal irritation is common in patients taking aspirin preparations, and nausea, vomiting dyspepsia, gastritis, gastrointestinal erosions and ulceration have been reported. Anaemia may occur following chronic gastrointestinal blood loss or acute haemorrhage.
Skin and subcutaneous tissue disorders: Skin reactions may occur in susceptible patients.
Renal and Urinary disorders: urate kidney stones
4.9 Overdose
Produces dizziness, tinnitus, sweating, nausea and vomiting, confusion and hyperventilation. Gastric lavage, forced alkaline diuresis and supportive therapy, restoration of acid-base balance may be necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
B01A C (blood and blood forming organs — antithrombotic agents)
Aspirin has analgesic, anti-inflammatory and anti-pyretic activity. It also has an antithrombotic action, mediated through inhibition of platelet activation, which has been shown to be useful in secondary prophylaxis following myocardial infarction and in patients with unstable angina or ischaemic stroke including cerebral transient attacks.
In the body it is rapidly converted to the salicylate form which has similar activity and works via the inhibition of the enzyme cyclo-oxygenase inhibiting prostaglandin synthesis.
The enteric coat is intended to resist gastric fluid whilst allowing disintegration in the intestinal fluid. Owing to the delay that the coating imposes on the release of the active ingredient, enteric coated tablets are unsuitable for the short-term relief of pain.
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 h before or within 30min after immediate release aspirin dosing (81mg), a decreased effect of ASA 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 of polysorbates and antacids.
Blood concentration: Single and multiple 100 mg doses of enteric- coated aspirin give systemic bioavailabilities of between 15% and 20% of that seen with immediate release aspirin preparations. Cmax of aspirin for several enteric -coated preparations has been shown to be approximately 100 -200ng/mlwith a half -life of approximately 1.7 hours. Plasma concentrations of salicylic acid increase disproportionately with dose -a 325 mg dose having a half-life of 2-3 hours and higher doses showing lower plasma concentrations in the presence of an increased half ~ life due to a disproportionate increase in volume of distribution.
Distribution: Aspirin is found in the saliva, milk, plasma and synovial fluid at concentrations less than blood and crosses the placenta.
Salicylate -extensive protein binding.
Aspirin-protein binding to a small extent.
Metabolism: In the blood, rapid hydrolysis to salicylic acid; glucuronic acid/ glycine conjugation to form glucuronides and salicyluronic acid; oxidation of a small proportion.
Excretion: Excreted in the urine mainly as salicyluronic acid. Salicylate reabsorbed by renal tubules in acid urine, and alkaline diuresis will increase the rate of excretion; 85% of dose excreted as free salicylate.
5.3 Preclinical safety data
There are no preclinical safety data of relevance to the prescriber.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch, sodium saccharin, lactose, anhydrous citric acid, calcium carbonate, talc and sodium lauryl sulphate.
6.2 Incompatibilities
Not known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store in a cool dry place. Protect from light.
6.5 Nature and contents of container
Blister packs: pack size: 24. Snapsafe packs: pack size: 25.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Ennogen Pharma Limited Unit G4,
Riverside Industrial Estate,
Riverside Way,
Dartford DA1 5BS UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 40147/0024
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30 July 1992
10 DATE OF REVISION OF THE TEXT
03/03/2012