Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Dexcel-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
Aspirin 75 mg tablets is not suitable for use as an anti-inflammatory/ analgesic/ antipyretic.
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 precipitate 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. The same applies for patients who also show allergic reaction to other substances (e.g. with skin reactions, itching or urticaria).
Serious skin reactions, including Steven-Johnsons syndrome, have rarely been reported in association with the use of acetylsalicylic acid (see section 4.8). Aspirin Tablets 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 salicylates. Continuous prolonged use of aspirin should be avoided in the elderly because of the risk of gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Where prolonged therapy is required, patients should be reviewed regularly.
Caution should be taken in patients with glucose-6-phosphate dehydrogenase deficiency as haemolytic anaemia may occur.
Aspirin 75 mg tablets is 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 and 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.
Care is advised when stopping antiplatelet therapy after stent insertion either after a fixed period of time or in preparation for a planned surgical procedure, as the balance between stent thrombosis and excessive bleeding has to be carefully assessed.
There is a possible association between aspirin and Reye’s Syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason aspirin should not be given to children aged under 16 years unless specifically indicated (e.g. for Kawasaki’s disease).
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. Patients should report any unusual bleeding symptoms to their physician. If gastrointestinal bleeding or ulceration occurs the treatment should be withdrawn.
Before commencing long term aspirin therapy for the management of cardiovascular or cerebrovascular disease patients should consult their doctor who can advise on the relative benefits versus the risks for the individual patient.
Concomitant treatment with Aspirin and other drugs that alter haemostasis (i.e. anticoagulants such as warfarin, thrombolytic and antiplatelet agents, anti-inflammatory drugs and selective serotonin reuptake inhibitors) is not recommended, unless strictly indicated, because they may enhance the risk of haemorrhage (see section 4.5). If the combination cannot be avoided, close observation for signs of bleeding is recommended.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration, such as oral corticosteroids, selective serotonin-reuptake inhibitors and deferasirox (see section 4.5).
Acetylsalicylic acid in low doses reduces uric acid excretion. Due to this fact, patients who tend to have reduced uric acid excretion may experience gout attacks (see section 4.5).
The risk of hypoglycaemic effect with sulfonylureas and insulins may be potentiated with Aspirin 75mg tablets taken at over dosage (see section 4.5).
Aspirin should be avoided in late pregnancy and generally during breast feeding (see section 4.6).
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The combined drugs, methotrexate and acetylsalicylic acid, enhance haematological toxicity of methotrexate due to the decreased renal clearance of methotrexate by acetylsalicylic acid. Therefore, the concomitant use of methotrexate (at doses >15 mg/week) with Aspirin 75 mg tablets is contraindicated (see section 4.3).
Salicylates reverse the effect of probenecid and sulfinpyrazone. The combination should be avoided.
Increased risk of bleeding due to inhibited thrombocyte function, injury of the duodenal mucosa and displacement of oral anticoagulants from their plasma protein binding sites. The bleeding time should be monitored (see section 4.4).
Increased risk of gastrointestinal bleeding (see section 4.4).
Salicylics may increase the hypoglycaemic effect of sulphonylureas.
Acetylsalicylic acid impairs the renal excretion of digoxin and lithium, resulting in increased plasma concentrations.Monitoring of plasma concentrations of digoxin and lithium is recommended when initiating and terminating treatment with acetylsalicylic acid. Dose adjustment may be necessary.
NSAIDs may decrease the antihypertensive effects of diuretics and other antihypertensive agents. Patients with hypertension should be carefully monitored. As for other NSAIDs concomitant administration with ACE-inhibitors increases the risk of acute renal insufficiency. Diuretics: Risk of acute renal failure due to the decreased glomerular filtration via decreased renal prostaglandin synthesis. Hydrating the patient and monitoring renal function at the start of the treatment is recommended.
Concurrent administration can increase side effects. Use of two or more NSAIDs increases risk of gastrointestinal haemorrhage.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
Concomitant use of NSAIDs and ciclosporin or tacrolimus may increase the nephrotoxic effect of ciclosporin and tacrolimus. The renal function should be monitored in case of concomitant use of these agents and acetylsalicylic acid.
The risk of gastrointestinal bleeding and ulceration is increased when acetylsalicylic acid and corticostetoids are co-administered (see section 4.4). Corticosteroids reduce the plasma salicylate concentration and salicylate toxicity may occur following withdrawal of corticosteroids.
The combined drugs, methotrexate and acetylsalicylic acid, may increase haematological toxicity of methotrexate due to decreased renal clearance of methotrexate by acetylsalicylic acid. Weekly blood count checks should be done during the first weeks of the combination. Enhanced monitoring should take place in the presence of even mildly impaired renal function, as well, as in elderly.
Reduced excretion of acetazolamide; salicylate intoxication has occurred in patients on high dose salicylate regimes and carbonic anhydrase inhibitors. Concurrent administration of carbonic anhydrase inhibitors such as acetazolamide and salicylates may result in severe acidosis and increased central nervous system toxicity.
The excretion of aspirin is increased in alkaline urine; kaolin possibly reduces absorption. Antacids will reduce the effect of aspirin. Principle incompatibilities are iron salts, carbonates and alkali hydroxides.
The manufacturer of mifepristone recommends that aspirin should be avoided until eight to twelve days after mifepristone has been discontinued.
Concomitant administration of alcohol and acetylsalicylic acid increases the risk of gastrointestinal bleeding.
Metoclopramide enhances the effects of aspirin by increasing the rate of absorption.
Salicylate diminishes the binding of phenytoin to plasma albumin. This may lead to decreased total phenytoin levels in plasma, but increased free phenytoin fraction. The unbound concentration, and thereby the therapeutic effect, does not appear to be significantly altered. Acetylsalicylic acid has been reported to decrease the binding of valproate to serum albumin, thereby increasing its free plasma concentrations at steady state.
The plasma concentration of zafirlukst is increased.
The toxicity of sulphonamides may be increased.
Aspirin may interfere with thyroid function tests.
Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.
There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day. Therefore, the recommendations below for doses of 500 mg/day and above apply also for this dose range.
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased preand post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
Consequently, acetylsalicylic acid at doses of 100 mg/day and higher is contraindicated during the third trimester of pregnancy.
As aspirin is excreted in breast milk, Aspirin 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.
Aspirin does not usually affect the ability to drive or operate machinery.
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).
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.
Aspirin decreases platelet adhesiveness and, in large doses, may cause hypoprothrombinaemia.
Existing (haematemesis, melaena) or occult gastrointestinal bleeding, which may lead to iron deficiency anaemia (more common at higher doses).
Haemolytic anaemia can occur in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Rare: Hypersensitivity reactions, skin rashes, urticarial, asthma, bronchospasm, angio-oedema, allergic oedema, anaphylactic reactions including shock.
Not known: Hyperuricemia.
Rare: Intracranial haemorrhage.
Not known: Headache, vertigo.
Not known: Reduced hearing ability; tinnitus.
Rare: Hemorrhagic vasculitis.
Uncommon: Rhinitis, dyspnoea.
Rare: Bronchospasm, asthma attacks.
Rare: Menorrhagia.
Common: Dyspepsia.
Rare: Severe gastrointestinal haemorrhage, nausea, vomiting, gastritis.
Not known: Gastric or duodenal ulcers and perforation, diarrhoea.
Not known: Hepatic insufficiency.
Uncommon: Urticaria.
Rare: Steven-Johnsons syndrome, Lyells syndrome, purpura, erythema nodosum, erythema multiforme.
Not known: Impaired renal function, salt and water retention, urate kidney stones.
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medical product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store.
Not applicable.
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