ASPIRIN

Posology Adults Secondary prevention of myocardial infarction:

The recommended dose is 75-160 mg once daily. Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris: The recommended dose is 75-160 mg once daily.

History of unstable angina pectoris, except during the acute phase:

The recommended dose is 75-160 mg once daily.

Prevention of graft occlusion after Coronary Artery Bypass Grafting (CABG):

The recommended dose is 75-160 mg once daily.

Coronary angioplasty, except during the acute phase:

The recommended dose is 75-160 mg once daily. Secondary prevention of transient ischaemic attacks (TIA) and ischaemic cerebrovascular accidents (CVA), provided intracerebral haemorrhages have been ruled out: The recommended dose is 75-300 mg once daily.

Acute myocardial infarction:

The recommended loading dose is 150-300 mg followed by a lower dose (75-160 mg) daily thereafter. Aspirin should not be used at higher doses unless advised by a doctor, and the dose should not exceed 300 mg a day. Elderly patients 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. 4). Method of administration For oral use. The tablets should be swallowed with sufficient fluid (1/2 glass of water).

Duration of administration:

Long-term treatment with the lowest possible dose.

Tabulated list of adverse reactions Side effects are grouped on the basis of System Organ Class. 000 Not known: frequency cannot be estimated from the available data. System organ class Common Uncommon Rare Not known Blood and lymphatic system disorders Increased bleeding tendencies Thrombocytopenia, agranulocytosis, aplastic anaemia 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 Hypersensitivity reactions, angio- oedema, allergic oedema, anaphylactic reactions including shock. Metabolism and nutrition disorders Hyperuricemia, hypoglycaemia Nervous system disorders Intracranial haemorrhage Headache, vertigo Ear and labyrinth disorders Reduced hearing ability; tinnitus Vascular disorders Haemorrhagic vasculitis Respiratory, thoracic and mediastinal disorders Rhinitis, dyspnoea Bronchospasm, asthma attacks Gastrointestinal disorders Dyspepsia, nausea, vomiting, diarrhoea Severe gastrointestinal haemorrhage, Gastric or duodenal ulcers and perforation Hepatobiliary disorders Reye’s syndrome Hepatic insufficiency, hepatic enzyme increased Skin and subcutaneous tissue disorders Urticaria Stevens-Johnson syndrome, Lyells syndrome, purpura, erythema nodosum, erythema multiforme Renal and urinary disorders Impaired renal function, acute renal failure Reproductive system and breast disorders 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. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Aspirin is not suitable for use as an anti-inflammatory, analgesic or 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.

Aspirin is not recommended during menorrhagia where it may increase menstrual bleeding. Aspirin is to be used with caution in cases of uncontrolled 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). 3). 8). The treatment with Aspirin should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. 2). Where prolonged therapy is required, these patients should be reviewed regularly.

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. 8). 5). Aspirin should be used with caution in patients with Glucose-6-phosphate dehydrogenase deficiency.

g. 5).