Aspirin is an anti-inflammatory analgesic and antipyretic. ATC code: N02BA01

aspirin

Each tablet contains 300mg Aspirin PhEur

White uncoated tablets

1) The relief of headache, toothache, migraine, neuralgia, sore throat, dysmenorrhoea.

2) The symptomatic relief of influenza, feverishness, rheumatic pains, sciatica, lumbago, fibrositis, muscular aches and pains.

3) 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 and cerebral transient ischaemic attacks.

Adults including elderly: 1-2 tablets (300-600mg) every 3-4 hours as required, to a maximum of 12 tablets (3.6g) daily in divided doses.

Antithrombotic action: For its antithrombotic effect following myocardial infarction, transient ischaemic attack, or in patients with unstable angina, the recommended dose is 300mg daily

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

Adults including elderly: 1-2 tablets (300-600mg) every 3-4 hours as required, to a maximum of 12 tablets (3.6g) daily in divided doses.

Aspirin should not be taken by patients with the following conditions:

• Known hypersensitivity to aspirin, other ingredients in the product, other salicylates or non-steroidal anti-inflammatory drugs (a patient may have developed anaphylaxis, angioedema, asthma, rhinitis or urticaria induced by aspirin or other NSAIDs).

• Nasal polyps associated with asthma (high risk of severe sensitivity reactions).

• Active peptic ulceration or a past history of ulceration or dyspepsia.

• Haemophilia or other haemorrhagic disorder (including thrombocytopenia) as there is an increased risk of bleeding.

• Concurrent anticoagulant therapy should be avoided.

• Severe hepatic impairment

• Severe renal impairment

• Severe cardiac failure

• third trimester of pregnancy

• children under 16 years old, unless specifically indicated (e.g. Kawasaki's disease)

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 on the advice of a doctor.

Aspirin should be used with caution in patients with:

• allergic disease

• anaemia (may be exacerbated by GI blood loss)

• asthma (increased risk of bronchospastic sensitivity reactions)

• cardiac failure (conditions which predispose to fluid retention)

• dehydration

• glucose-6-phosphate dehydrogenase deficiency (aspirin rarely causes haemolytic anaemia)

• gout (serum urate may be increased)

• hepatic function impairment (avoid if severe)

• renal function impairment

• surgery. Aspirin should be discontinued several days before scheduled surgery (including dental extractions)

• systemic lupus erythematosus and other connective tissue disorders (hepatic and renal function may be impaired in these conditions)

• thyrotoxicosis (may be exacerbated by large doses of salicylates)

• long term use in elderly patients should be avoided due to a risk of gastrointestinal bleeding.

• 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 versus the risks for the individual patient.

• Vaccine recipients should avoid use of salicylates for 6 weeks after varicella vaccination.

• the following warnings are on the OTC product labelling:

• Do not take if you have a stomach ulcer

• If symptoms persist for more than 3 days, consult your doctor

• Medicines should not be taken in pregnancy without consulting your doctor

• Keep out of the reach of children

• Do not give to children aged under 16 years, unless on the advice of a doctor.

The following drug interactions should be considered when prescribing aspirin:

• Alcohol - may enhance gastro-intestinal side effect of aspirin.

• Analgesics - avoid concomitant administration of other salicylates or other NSAIDs (including topical formulations) as increased risk of side effects.

• Alkalizers of urine (eg carbonic anhydrase inhibitors, antacids, citrates) - increased excretion of aspirin.

• Anticoagulants or platelet aggregation inhibitors - increased risk of bleeding.

• Antiepileptic drugs (eg phenytoin, sodium valproate) - increased effect.

• Corticosteroids - increased risk of gastro-intestinal bleeding or ulceration.

• Dipyridamole - increase in peak concentration.

• Diuretics - frusemide and acetazolamide (risk of toxic effects), spironolactone (antagonized diuretic action).

• Hypoglycaemics - enhanced activity.

• Methotrexate - increased toxicity.

• Metoclopramide and domperidone - increased rate of absorption of aspirin.

• Mifepristone - avoid aspirin until 8-12 days after mifepristone.

• Ototoxic medicine (eg vancomycin) - potential for ototoxicity increased. Hearing loss may occur and may progress to deafness even after discontinuation of the medication. Effects may be reversible but are usually permanent.

• Uricosurics (eg probenecid, sulphinpyrazone) - effects of uricosurics reduced.

• Laboratory investigations - aspirin may interfere with some laboratory tests such as urine 5-hydroxyindoleacetic acid determinations and copper sulphate urine sugar tests.

• ACE inhibitors – reduced hypotensive effect, increased risk of renal impairment and hypokalaemia. Monitoring of renal function may be required

• Calcium-channel blockers – reduced hypotensive effects, increased antiplatelet effect which rarely results in pro-longed bleeding time.

• SSRIs – increased risk of gastrointestinal bleeding

• Varicella vaccine - Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with varicella vaccine as Reye's syndrome has been reported following use of salicylates during wild-type varicella infection.

• Ginkgo Biloba – possible increase in risk of bleeding.

Experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid 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

Adverse effects of aspirin treatment which have been reported include:

Blood and lymphatic system disorders - anaemia, haemolytic anaemia, hypoprothrombinaemia, thrombocytopenia, aplastic anaemia, pancytopenia, prolonged bleeding time, occult blood loss, elevated transaminase levels, agranulocytosis.

Gastrointestinal disorders - gastrointestinal bleeding, erosions, perforations or ulceration which can occasionally be major (may develop bloody or black tarry stools, severe stomach pain and vomiting blood), gastrointestinal irritation (mild stomach pain, heartburn, vomiting and nausea). Fatalities have occurred.

Hepatic disorders - hepatitis (particularly in patients with SLE or connective tissue disease)

Renal and urinary disorders – disturbances of renal function

Ear and labyrinth disorders - tinnitus.

Salicylism - mild chronic salicylate intoxication may occur after repeated administration of large doses, symptoms include dizziness, tinnitus, deafness, sweating, nausea, vomiting, headache and mental confusion, and may be controlled by reducing the dose.

General disorders and administration site conditions – Allergic reactions - rhinitis, urticaria, purpura, Stevens-Johnson syndrome, angioneurotic oedema, angio-oedema, asthma, worsening of asthma, bronchospasms.

Children

Aspirin may be associated with the development of Reye's Syndrome (encephalopathy and hepatic failure) in children presenting with an acute febrile illness.

Actavis UK Ltd

POM

04 November 2011