Disprin Extra Strength 500mg Effervescent 16 Tablets

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500mg EFFERVESCENT TABLETS. ASPIRIN (acetylsalicylic acid).


FOR FAST RELIEF OF: Headache, Toothache, Feverishness, Muscular aches and pains.

TO RELIEVE SYMPTOMS OF: Colds and flu, Sore throat, Neuralgia, Lumbago.

For oral use, after dissolution in water.

Adults: One tablet. The dose may be repeated every 3-4 hours, if necessary, to a maximum of eight tablets in 24 hours.

There is no indication that dosage need be modified in the elderly.

Do not give to children and adolescents aged under 16 years, except on medical advice, where the benefit outweighs the risk.

Elderly: Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients who are more prone to adverse events.

The lowest dose compatible with adequate safe clinical control should be employed.

The use with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms (See section 4.2, and GI and cardiovascular risks below).

Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without any warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and 4.5).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving Disprin Extra Strength, the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's Disease) as their condition may be exacerbated (see section 4.8 – undesirable effects).

Cardiovascular and cerebrovascular effects: Clinical trial and epidemiological data suggest that use of NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There is insufficient data to exclude such a risk for aspirin when given at a daily dose of ≤4000mg.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Disprin Extra Strength should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

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 and adolescents aged 16 years unless specifically indicated.

Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and performation which may be fatal (see section 4.2)

Elderly patients are particularly susceptible to the adverse effects of non-steroidal anti-inflammatory drugs. Unsupervised prolonged use of non-steroidal anti-inflammatory drugs in the elderly is not recommended.

This product should be taken only when necessary.

Prolonged use except on medical advice can be harmful.

Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration.

The doctor should be consulted if there is no improvement in 24 hours.

If the patient is on any medication consult the doctor or pharmacist before using.

If the patient suffers from asthma, has renal or hepatic impairment, or a history of peptic ulceration or inflammatory bowel disease, then a doctor should be consulted before taking the product.

Always read the instructions before use

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