DISPERSIBLE ASPIRIN

For the management of cardiovascular or cerebrovascular disease:

Adults The advice of a doctor should be sought before commencing therapy for the first time. The usual dosage, for long term use, is 75 – 150 mg 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.

Elderly In general, acetylsalicylic acids should be used with caution in elderly patients who are more prone to adverse events. 4). Treatment should be reviewed at regular intervals. Method of Administration For oral administration. The tablets should be dispersed in water before taking.

Children under 16 years of age Do not give to children under 16 years of age (see ‘Special Warnings and Precautions for Use’)

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, angio-oedema, allergic oedema, anaphylactic reactions including shock Metabolism and digestive system 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:

Hemorrhagic vasculitis. Respiratory, thoracic Uncommon: and mediastinal disorders Rhinitis, dyspnoea.

Dispersible Aspirin 75 mg Tablets are not suitable for use as an anti- inflammatory/analgesic/antipyretic. Recommended for use in adults and adolescents from 16 years of age. This medicinal product is not recommended for use in adolescents/children under 16 years unless the expected benefits outweigh the risks.

Acetylsalicylic acid may be a contributory factor in the causation of Reye's Syndrome in some children. g. tooth extraction). Use with caution before surgery, including tooth extraction. Temporary discontinuation of treatment may be necessary.

Dispersible Aspirin 75 mg Tablets are not recommended during menorrhagia where it may increase menstrual bleeding. Dispersible Aspirin 75 mg Tablets are 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. Acetylsalicylic acid should be used with caution 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. 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 75 mg Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. 2). Where prolonged therapy is required, patients should be reviewed regularly.

g. 5).