POSTMI

Posology Analgesic, anti-inflammatory, anti-pyretic; Adults (including the elderly) and children over 16 years: 3 tablets (900mg) 3-4 times daily as required, at least 4 hours apart. g. for Kawasaki’s disease). Method of administration For oral administration.

Aspirin must not be chewed or crushed. The tablets are best taken before meals.

The information below lists reported adverse reactions, ranked using the following frequency classification: Common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).

Side effects are generally mild and infrequent:

System Organ Class Frequency Undesirable Effects Common Increased bleeding tendencies Rare Thrombocytopenia, granulocytosis, aplastic anaemia, anaemia following chronic GI blood loss or acute haemorrhage. Blood and lymphatic system disorders Not known Bleeding time prolonged**, epistaxis, gingival bleeding, platelet adhesiveness decreased, hypoprothrombinaemia when large doses are used, haematuria, purpura, ecchymoses, haemoptysis, haematemesis, malaena*, gastrointestinal bleeding haematoma, cerebral haemorrhage, haemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency).

Immune system disorders Rare Hypersensitivity reactions, allergic respiratory disease exacerbated by aspirin, angio-oedema, allergic oedema, anaphylactic reaction including shock. Metabolism and nutrition disorders Not known Hyperuricaemia Rare Intracranial haemorrhageNervous system disorders Not known Headache, vertigo Ear and Labyrinth disorders Not known Reduced hearing ability; tinnitus Vascular disorders Rare Haemorrhagic vasculitis Uncommon Rhinitis, dyspnoeaRespiratory, thoracic and mediastinal disorders Rare Bronchospasm, asthma attacks Common Dyspepsia Rare Gastrointestinal haemorrhage, nausea, vomiting Gastrointestinal disorders Not known Gastric or duodenal ulcers and perforation, diarrhoea or gastritis Hepatobiliary disorders Not known Hepatic insufficiency Uncommon UrticariaSkin and subcutaneous tissue disorders Rare Steven-Johnsons syndrome, Lyells syndrome, purpura, erythema nodosum, erythema multiforme or skin rash.

Renal and urinary tract disorders Not known Impaired renal function, salt and water retention. * Existing (haematemesis, melaena) or occult gastrointestinal bleeding, which may lead to iron deficiency anaemia (more common at higher doses).

** Symptoms may persist for a period of 4–8 days after acetylsalicylic acid discontinuation. As a result there may be an increased risk of bleeding during surgical procedures. 4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Aspirin should be used with caution in patients with asthma or allergic disorders. Caution should also be exercised in patients with: • hepatic impairment; • renal impairment; • dehydration; • uncontrolled hypertension. High doses of aspirin may precipitate acute haemolytic anaemia in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency.

Aspirin should be used with caution in the elderly because of the risk of serious side effects. The elderly may be more susceptible to the toxic effects of salicylates. Continuous prolonged use of aspirin should be avoided in the elderly because of the risk of gastrointestinal bleeding and perforation which may be fatal.

For elderly patients, the lowest possible dose for the shortest period of time should be used. 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.

g. for Kawasaki’s disease). Aspirin prolongs bleeding time, mainly by inhibiting platelet aggregation. g. tooth extraction). Use with caution before surgery, including tooth extraction. Temporary discontinuation of treatment may be necessary.

Aspirin may also precipitate bronchospasm or induce attacks of asthma in susceptible subjects. Risk factors are existing asthma, hay fever, nasal polyps or chronic respiratory diseases. g. with skin reactions, itching or urticaria. 8).

Aspirin should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Aspirin may interfere with insulin and glucagon in diabetes. 3). 3). Patients with hypertension should be carefully monitored.

e. less than 1 mmol (23 mg) per tablet, that is to say essentially ‘sodium-free’.

6).