Section 4.4 A new paragraph reading "Aspirin decreases platelet adhesiveness and increases bleeding time. Haematological and haemorrhagic effects can occur, and may be severe. Patients should report any unusual bleeding symptoms to their physician." has been added.
Section 4.5 The first sentence has been amended: "Salicylates may enhance the effect of
anticoagulants, oral hypoglycaemic agents, phenytoin and sodium valproate."
The following text has been added:
"Aspirin may potentiate the effect of heparin and increases the risk of bleeding with oral anticoagulants, antiplatelet agents and fibrinolytics.
Plasma salicylate concentrations may be reduced by concurrent use of corticosteroids, and salicylate toxicity may ocur following withdrawal of the corticosteroids. The risk of gastrointestinal ulceration and bleeding may be increased when aspirin and corticosteroids are co-administered.
Concurrent use of aspirin and other NSAIDs should be avoided. Use of two or more NSAID preparations increases the risk of serious gastrointestinal haemorrhage.
Concurrent administration of carbonic anhydrase inhibitors such as acetazolamide and salicylates may result in severe acidosis and increased central nervous system toxicity."
Section 4.6 Has been amended as follows (text in bold has been added):
Usage in pregnancy: Aspirin does not appear to have teratogenic effects.
Pregnancy: Although clinical and epidemiological evidence suggests the safety of aspirin for use in pregnancy, caution should be exercised when considering use in pregnant patients. Aspirin has the ability to alter platelet function and there may be a risk of haemorrhage in infants whose mothers have consumed aspirin during pregnancy.
Prolonged pregnancy and labour, with increased bleeding before and after delivery, decreased birth weight and increased rate of stillbirth
were have been reported with high blood salicylate levels. With high doses there may be permanent closure of the ductus arteriosus and possible persistent pulmonary hypertension in the newborn. Analgesic doses of aspirin should be avoided during the last trimester of pregnancy.
Lactation: As aspirin is excreted in breast milk, Nu-Seals should not be taken by patients who are breast-feeding, as there is a risk of Reye's syndrome in the infant. High maternal doses may impair platelet function in the infant.
Section 4.8 This section has been completely re-written.
Section 4.9 This section has been completely re-written.