Aspirin 75 mg gastro-resistant tablets

Each tablet contains 75mg of Aspirin

Pink, gastro-resistant tablets with 75 on black ink on each tablet

Enteric coated tablets

Aspirin 75mg may be used for the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery

Adults (including the elderly)

The usual dose, for long term use, is 75-150mg 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.

Children

Aspirin 75mg tablets must not be chewed or crushed.

The tablets are best taken before meals.

Aspirin 75mg tablets are contra-indicated in the following:

• Active peptic ulceration or history of peptic ulceration

• Haemophilia

• Hypersensitivity to aspirin or any other NSAIDs, including those in whom attacks of asthma, angioedema, urticaria, rhinitis have been precipitated by aspirin or any other NSAID

• Hypersensitivity to any other of the constituents

• In children under 16 years unless advised by a doctor e.g. Kawasaki's disease

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.

Caution should be exercised in patients with asthma, allergic disease, impairment of hepatic or renal function (avoid if severe) and dehydration.

Do not take with non-steroidal anti-inflammatory drugs as the effects would be additional

Do not take if you have a stomach ulcer

Medicines should not be taken during pregnancy without consulting your doctor. Keep out of the reach and sight of children.

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 under 16 years unless specifically indicated (e.g. Kawasaki's disease)

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 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).

Avoid concomitant administration of antacids and absorbents (excretion of aspirin is increased in alkaline urine whilst kaolin may reduce absorption).

Aspirin 75mg may enhance the effects of anticoagulants and oral hypoglycaemic agents.

Other antiplatlet drugs such as clopidogrel and ticlopidine increase the risk of bleeding.

Aspirin 75mg may enhance the effects of phenytoin and sodium valproate.

Administration together with corticosteroids may increase the risk of gastrointestinal bleeding and ulceration; corticosteroids reduce plasma concentration.

The activity of methotrexate may be markedly enhanced and its toxicity increased

Aspirin 75mg may antagonise the diuretic effect of spironolactone and may reduce acetazolamide excretion (risk of toxicity).

Aspirin 75mg increases plasma concentration of zafirlukast.

Metoclopramide and domperidone enhance the effect of aspirin (increased rate of absorption).

Avoid concomitant administration with mifepristone (theoretical interaction).

Aspirin 75mg may inhibit action of uricosurics.

The toxicity of sulphonamides may also be increased.

Aspirin 75mg may reduce the efficacy of antihypertensive drugs.

Aspirin is pharmaceutically incompatible with iron salts and alkalis.

There is clinical and epidemiological evidence of safety in human pregnancy.

Aspirin may prolong labour and contribute to maternal and neonatal bleeding and is best avoided at term and during breast feeding – possible risk of Reye's syndrome.

Regular use of high doses could impair platelet function and produce hypoprothrombinaemia in the infant if neonatal Vitamin K stores are low.

Aspirin does not usually affect the ability to drive or operate machinery.

Aspirin may precipitate bronchospasm and skin reactions and induce attacks of asthma in susceptible subjects. It may induce gastro-intestinal haemorrhage, occasionally major.

Dizziness, tinnitus, deafness, vasodilation and sweating, nausea and vomiting, headache and mental confusion. If more severe; hyperventilation, fever, restlessness, ketosis, respiratory alkalosis and metabolic acidosis.

Coma, if severe, with cardiovascular collapse and respiratory failure.

Hypoglycaemia may be severe in children.

Overdosage should be treated initially by aspiration and lavage and a saline purgative such as sodium sulphate, 30g in 250ml of water should be given to promote peristalsis.

Otherwise treat as for aspirin poisoning and observe for at least 72 hours to allow for possible delayed reaction from gastro-resistant system.

Restoration of acid-base balance may be necessary.

Aspirin is an analgesic and antipyretic with anti-inflammatory properties.

Aspirin inhibits prostaglandin synthetase.

Aspirin inhibits platelet aggregation.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 hours before or within 30 minutes after immediate release aspirin (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. 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.

Absorption

Absorption is more rapid in patients with achlorhydria and also followed administration of polysorbates and antacids.

To prevent stomach irritation, Aspirin 75mg tablets have a special gastro-resistant coating so that aspirin is not released until it passes through the stomach.

Distribution

Aspirin is found in the saliva, milk, plasma and synovial fluid at concentrations less than blood and crosses the placenta.

Salicylate: extensive protein binding

Aspirin: protein binding to a small extent.

Metabolism

In the blood, rapid hydrolysis to salicylic acid; glucuronic acid/glycine conjugation to form glucuronides and salicyluronic acid, oxidation of a small proportion.

Excretion

Excreted in the urine mainly as salicyluronic acid. Salicylate reabsorbed by renal tubules in acid urine and alkaline diuresis will increase the rate of excretion; 85% of dose excreted as free salicylate.

Not Applicable

Anhydrous Lactose

Colloidal Silica

Pregelatinised Starch

Zinc Stearate

Titanium Dioxide (E171)

Polyvinyl Acetate Phthalate

Acetylated vegetable Oil Monoglyceride

Hydroxypropyl Cellulose

Red Iron Oxide (E172)

Colorcon Black Ink S-1-8100HV

Potable Water

Industrial Methylated Spirits 99%

Not Applicable

Store below 25°C

(i) White blister pack (PVC/PVDC 250 micron film, lidding is aluminium hard temper foil 20 microns with heat sealed lacquer) containing 28, 30, 56, 60 or 84 tablets.

(ii) White polypropylene container (securitainer type, with white lid 26x 51mm) containing 28, 56, 100 or 500 tablets

Not Applicable

Pinewood Laboratories Ltd.

trading as Pinewood Healthcare

Ballymacarbry

Clonmel

Co. Tipperary

Ireland.

PL 04917/0070

18 March 2004

03 March 2009

21/06/2011