ANADIN Original Tablet Ref.[50613] Active ingredients: Acetylsalicylic acid Caffeine

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

Do not take if you have a stomach ulcer.

Do not exceed the stated dose.

If symptoms persist for more than 3 days consult your doctor.

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).

Other NSAIDs and corticosteroids: Concurrent use of other NSAIDs or corticosteroids may increase the likelihood of GI side effects.

Diuretics: Antagonism of the diuretic effect.

Anticoagulants: Increased risk of bleeding due to antiplatelet effect.

Metoclopramide: Metoclopramide increases the rate of absorption of aspirin. However, concurrent use need not be avoided.

Phenytoin: The effect of phenytoin may be enhanced by aspirin. However, no special precautions are needed.

Valproate: The effect of valproate may be enhanced by aspirin.

Methotrexate: Delayed excretion and increased toxicity of methotrexate.

Warfarin: Low-dose aspirin (75 to 325 mg daily) increases the risk of bleeding when given with warfarin. High doses of aspirin (4 g daily or more) can also increase prothrombin times in patients taking warfarin. Avoid high-dose aspirin. If low-dose aspirin is indicated, monitor for signs of bleeding. Consider giving gastroprotection (e.g. a proton pump inhibitor) to at-risk patients.

Sulfinpyrazone: The uricosuric effects of aspirin and sulfinpyrazone are mutually antagonistic. Concurrent use for uricosuria should be avoided. Doses of aspirin as low as 700 mg can cause an appreciable fall in uric acid excretion but the effects of a small dose are probably of little practical importance. Sulfinpyrazone can cause gastric bleeding and inhibit platelet aggregation which may be additive with aspirin. (Severity – moderate).

Blood pressure lowering treatments (ACE inhibitors): High-dose aspirin can reduce the antihypertensive efficacy of ACE inhibitors. Low-dose aspirin (100 mg daily or less) appears to have little effect. It is unclear if aspirin attenuates the benefits of ACE inhibitors in heart failure: the likelihood of an interaction possibly depends on disease state and its severity. (Severity – moderate).

Antacids: The serum salicylate concentrations of patients taking aspirin have been reduced to subtherapeutic levels by aluminium and magnesium hydroxide. Care should be taken to monitor serum salicylate levels if any antacid is started or stopped in patients where the control of salicylate levels is critical. Occasional doses of aspirin for analgesia and aspirin given in doses that produce low salicylate levels do not appear to be affected. (Severity – moderate).

Cilostazol: Concurrent use of multiple antiplatelets would be expected to increase the risk of bleeding. Aspirin very slightly increases the exposure to cilostazol with no clinically relevant effect on bleeding times. Be aware of the increased risk of bleeding. Cilostazol is contraindicated with two or more antiplatelets or anticoagulants (UK). (Severity – moderate).

Mifepristone: Theoretically aspirin and NSAIDs might reduce the efficacy of mifepristone. However, evidence from two studies with naproxen and diclofenac suggests no reduction in mifepristone efficacy. No action needed. (Severity – moderate but theoretical).

Probenecid: The uricosuric effects of aspirin and probenecid are mutually antagonistic. Low dose, enteric-coated aspirin appears not to interact. Regular dosing with substantial amounts of salicylates should be avoided, but small very occasional analgesic doses probably do not matter. Serum salicylate levels of 5 to 10 mg/100 mL are necessary before this interaction occurs. (Severity – moderate).

Venlafaxine/SSRIs: The bleeding risk associated with antiplatelet drugs such as aspirin might be further increased by the concurrent use of an SNRI/SSRI. Advise patients to report bleeding. Consider gastroprotection (such as a proton pump inhibitor) in those at high risk of gastrointestinal bleeding (e.g. history of gastrointestinal bleeding, the elderly). (Severity – severe).

Sympathomimetics: Caffeine acts synergistically towards the hypertensive and tachycardic effects of sympathomimetics.

There is clinical and epidemiological evidence of safety of aspirin in pregnancy, but it may prolong labour and contribute to maternal and neonatal bleeding, and so should not be used in late pregnancy.

Aspirin appears in breast milk, and regular high doses may affect neonatal clotting. Not recommended while breast feeding due to possible risk of Reye’s Syndrome as well as neonatal bleeding due to hypoprothrombinaemia.

Caffeine appears in breast milk. Irritability and poor sleeping pattern in the infant have been reported.

None known.

Side effects are mild and infrequent, but there is a high incidence of gastro-intestinal irritation with slight asymptomatic blood loss. Increased bleeding time. Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions in susceptible individuals. Aspirin may induce gastro-intestinal haemorrhage, occasionally major. It may precipitate gout in susceptible individuals. Possible risk of Reye’s Syndrome in children under 16 years.

High doses of caffeine can cause tremor and palpitations.

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 at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.