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ASPIRIN ENTERIC COATED is a brand name for Aspirin (also known as Acetylsalicylic Acid). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery. Owing to the delayed release of the aspirin imposed by the enteric coating, these tablets are not suitable for short term pain relief.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The advice of a doctor should be sought before commencing therapy for the first time. The usual dosage for long term use is one to two tablets (75-150mg) to be taken once daily. In some circumstances a higher dose may be appropriate, especially in the short term, and up to 4 tablets (300mg) a day may be used on the advice of a doctor.
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. g. for Kawasaki’s disease). 4 ‘Special Warnings and Special Precautions for Use’).
Method of administration For oral administration to adults only. Take the tablet with water, do not cut, chew or crush the tablet. Swallow whole.
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 the lymphatic system disorders Common:
Increased bleeding tendencies.
Rare:
Thrombocytopenia, granulocytosis, aplastic anaemia.
Not known:
Cases of bleeding with prolonged bleeding time such as epistaxis, haematuria, purpura, ecchymoses, haemoptysis, haematoma, cerebral haemorrhage and 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 and Mediastinal disorders Uncommon:
Aspirin Enteric Coated Tablets 75mg is 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.
Caution should be exercised in patients with allergic disease, impairment of hepatic or renal function (avoid if severe) and dehydration, 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 also promote bronchospasm or induce attacks of asthma in susceptible subjects or promote other hypersensitivity reactions. 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. The elderly may be more susceptible to the toxic effects of NSAIDs, including acetylsalicylic acid especially gastrointestinal bleeding and perforation which may be fatal.
2). Where prolonged therapy is required, patients should be reviewed regularly. Aspirin Enteric Coated Tablets 75mg are not recommended during menorrhagia where it may increase menstrual bleeding. Aspirin prolongs bleeding time, mainly by inhibiting platelet aggregation and therefore it should be discontinued several days before scheduled surgical procedures.
Haematological & haemorrhagic effects can occur, and may be severe. Use with caution before surgery, including tooth extraction. Patients should report any unusual bleeding symptoms to their physician. Aspirin is to be used with caution in cases of hypertension and patients with a stomach ulcer or a history of stomach ulcers or duodenal ulcer or haemorrhagic episodes or undergoing therapy with anticoagulants.
g. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Rhinitis, dyspnoea.
Rare:
Bronchospasm, asthma attacks.
Reproductive System and mammary disorders Rare:
Menorrhagia 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:
Steven-Johnsons syndrome, Lyells syndrome, purpura, erythema nodosum, erythema multiforme.
Renal and urinary tract disorders Not known:
Impaired renal function, salt and water retention, urate kidney stones. 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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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. 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). 6). This medicinal product contains lactose and sucrose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.