DISPERSIBLE ASPIRIN

Posology The advice of a doctor should be sought before commencing therapy for the first time.

Adults and the elderly:

The usual dosage, for long term use, is 75-150mg once daily. In some circumstances a higher dose may be appropriate, especially in the short term, and up to 300mg a day may be used on the advice of a doctor. In general, acetylsalicylic acid should be used with caution in elderly patients who are more prone to adverse events.

4). Treatment should be reviewed at regular intervals. g. 4).

Method of administration:

Dispersible Aspirin Tablets should be dissolved in a glass of water and taken orally.

Side effects are grouped on the basis of System Organ Class.

Within each system organ class the frequencies are defined as:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and not known (cannot be estimated from the available data) Blood and lymphatic system disorders Common: Increased bleeding tendencies.

Rare:

Thrombocytopenia, granulocytosis, aplastic anaemia.

Not known:

Cases of bleeding with prolonged bleeding time such as epistaxis, gingival bleeding. 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.

Existing (haematemesis, melaena) or occult gastrointestinal bleeding, which may lead to iron deficiency anaemia (more common at higher doses).

Immune system disorders Rare:

Hypersensitivity reactions, angioedema, allergic oedema, anaphylactic reactions including shock.

Metabolism and nutrition disorders Not known:

Hyperuricemia.

Nervous system disorders Rare:

Intracranial haemorrhage Not known: Headache, vertigo.

Ear and labyrinth disorders Not known:

Reduced hearing ability, tinnitus.

Vascular disorders Rare:

Haemorrhagic vasculitis.

Respiratory, thoracic and mediastinal disorders Uncommon:

Rhinitis, dyspnoea.

Rare:

Bronchospasm, asthma attacks.

Gastrointestinal disorders Common:

Dyspepsia.

Rare:

Severe gastrointestinal haemorrhage, nausea, vomiting.

Not known:

Gastric or duodenal ulcers and perforation, diarrhoea.

Hepatobiliary disorders Not known:

Hepatic insufficiency Skin and subcutaneous tissue disorders Uncommon: Urticaria.

Rare:

Stevens-Johnson Syndrome, Lyells syndrome, purpura, erythema nodosum, erythema multiforme.

Renal and urinary disorders Not known:

Impaired renal function, salt and water retention.

Reproductive system and breast disorders Rare:

Menorrhagia 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.

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Dispersible Aspirin Tablets are not suitable for use as an anti- inflammatory/analgesic/antipyretic. 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 of aspirin versus the risks for the individual patient.

Acetylsalicylic acid should be used with caution in the presence of allergic disease, in patients with moderately impaired renal or hepatic function (contraindicated if severe), or in patients who are dehydrated, since the use of NSAIDs may result in deterioration of renal function.

Liver function tests should be performed regularly in patients presenting slight or moderate hepatic insufficiency. Aspirin 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 when given to children with a fever. Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal. g. for Kawasaki’s disease). g. tooth extraction). Use with caution before surgery, including tooth extraction.

Temporary discontinuation of treatment may be necessary. Dispersible Aspirin Tablets are not recommended during menorrhagia where it may increase menstrual bleeding. Acetylsalicylic acid may promote bronchospasm and asthma attacks or other hypersensitivity reactions.

Risk factors are existing asthma, hay fever, nasal polyps or chronic respiratory diseases. g. with skin reactions, itching or urticaria). 8). Dispersible Aspirin Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

6). This medicine contains lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 2). Where prolonged therapy is required, patients should be reviewed regularly.

Aspirin may induce gastro-intestinal haemorrhage, occasionally major. Aspirin is to be used with caution in cases of hypertension and when patients have a past history of gastric or duodenal ulcer or haemorrhagic episodes or are undergoing therapy with anticoagulants.

Patients should report any unusual bleeding symptoms to their physician. If gastrointestinal bleeding or ulceration occurs the treatment should be withdrawn. e. 5). If the combination cannot be avoided, close observation for signs of bleeding is recommended.

5). Acetylsalicylic acid in low doses reduces uric acid excretion. 5). 5).

1. g. for Kawasaki's disease). g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, rhinitis and urticaria) or to any of the other ingredients or non-steroidal anti-inflammatory drugs, and severe renal or hepatic impairment.

6). 5).