DISPRIN

Oral administration after dissolution in water.

Adults (including children 16 years and over):

Two to three tablets every 4 -6 hours. Do not exceed 12 tablets in 24 hours. g. for Kawasaki’s disease). There is no indication that dosage need be modified in the elderly. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 3 days. 4). 4). 4).

Adverse events which have been associated with acetylsalicylic acid are given below, tabulated by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class Frequency Adverse Events Blood and Not known Hypoprothrombinaemia, System Organ Class Frequency Adverse Events Lymphatic System Disorders thrombocytopenia, aplastic anaemia, agranulocytosis, pancytopenia Immune System Disorders Not known Hypersensitivity1, pyrexia, urticaria, pruritus, angioedema1 Metabolism and Nutrition Disorders Not known Sodium retention, fluid retention Nervous System Disorders Not known Aseptic meningitis Cardiac Disorders Not known Cardiac failure, oedema Vascular Disorders Not known Hypertension, haemorrhage intercranial Very rare Aspirin-exacerbated respiratory diseaseRespiratory, Thoracic and Mediastinal Disorders Not known Bronchospasm, asthma, dyspnoea, rhinitis1 Gastrointestinal Disorders Not known Gastrointestinal haemorrhage, gastrointestinal disturbances2, peptic ulcer, melaena, haematemesis, mouth ulceration Hepatobiliary Disorders Not known Hepatotoxicity Skin and Subcutaneous Tissue Disorders Not known Stevens-Johnson syndrome, toxic epidermal necrolysis, rash1 Renal and Urinary Disorders Not known Blood uric acid increased Investigations Not known Bleeding time prolonged, platelet adhesiveness decreased ¹ Hypersensitivity reactions may consist of (a) respiratory tract reactivity, including asthma, bronchospasm (potentially severe, even fatal) and dyspnoea; (b) various skin reactions, including urticaria, angioedema, pruritus, other skin eruptions, and more rarely bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

This medicine contains less than 1mmol sodium (23 mg) per dose, that is to state essentially ‘sodium-free’. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

8). Gastrointestinal bleeding, ulceration or perforation which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without 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 and in the elderly.

These patients should commence treatment on the lowest dose available. Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Acetylsalicylic acid decreases platelet adhesiveness and increases bleeding time. 5). 8). 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.

Acetylsalicylic acid should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Paediatric use:

There is a possible association between acetylsalicylic acid 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. g. for Kawasaki’s disease).

Cardiovascular effects:

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, hypertension, and oedema have been reported in association with NSAID therapy.

1. Hypersensitivity to other non-steroidal anti-inflammatory drugs. Nasal polyps associated with asthma. Should not be given to patients suffering from a previous history of peptic ulceration or active peptic ulceration or bleeding disorders including haemophilia.

Disprin contains soy protein. If you are allergic to peanut or soya do not use this medicinal product. Severe hepatic impairment. Severe renal impairment. Severe heart failure. 4). 6). 6).