NU-SEALS

Posology Adults Analgesic, antipyretic and anti-inflammatory actions:

The usual dose of aspirin is 300-900mg repeated three to four times daily according to clinical needs. In acute rheumatic disorders the dose is in the range of 4-8 g daily, taken in divided doses.

Antithrombotic action:

Patients should seek the advice of a doctor before commencing therapy for the first time. The usual dosage, for long-term use following myocardial infarction, transient ischaemic attack, or in patients with unstable angina, 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.

Antithrombotic action:

The risk-benefit ratio has not been fully established.

Elderly Analgesic, antipyretic and anti-inflammatory actions:

As for adults, the elderly are more likely to experience gastric side-effects and tinnitus. g. for Kawasaki’s disease). See ‘Special Warnings and Special Precautions for Use’. Method of administration For oral administration.

Summary of the safety profile The most commonly observed adverse events are gastrointestinal in nature. Tabulated list of adverse reactions Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

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 Not known: cannot be estimated from the available data Blood and lymphatic system disorders Not known: Anaemia1 Bleeding disorders2 Thrombocytopenia Immune system disorders Not known: Hypersensitivity reactions including skin rashes, urticaria, angioedema, asthma, bronchospasm and anaphylaxis.

Nervous system disorders Not known:

Cerebral haemorrhage Ear and labyrinth disorders Not known: Tinnitus Vascular disorders Not known: Haematoma Haemorrhage Respiratory thoracic and mediastinal disorders Not known: Epistaxis Haemoptysis Gastrointestinal disorders Not known: Gastrointestinal irritation Nausea Vomiting Dyspepsia Gastritis Gastrointestinal erosions Gastrointestinal ulcer Gastrointestinal bleeding Skin and subcutaneous tissue disorders Not known: Purpura Ecchymoses Renal and urinary disorders Not known: Urate kidney stones Haematuria Investigations Not known: Bleeding time prolonged2 Transaminases increased 1 may occur following chronic gastrointestinal blood loss or acute haemorrhage.

2 fatalities have occurred. 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.

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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. g. for Kawasaki’s disease). Aspirin can reduce uric acid excretions and therefore should be used with care in patients with gout or a history of gout.

Before commencing long-term aspirin therapy for the management of cerebrovascular or cardiovascular disease patients should consult their doctor who can advise on the relative benefits versus the risks for the individual patient. Aspirin decreases platelet adhesiveness and increases bleeding time.

Haematological and haemorrhagic effects can occur and may be severe. Patients should report any unusual bleeding symptoms to their physician. Salicylates should be used with caution in patients with inflammatory bowel disease or coagulation abnormalities as they may also induce gastro-intestinal haemorrhage, occasionally major.

They may also precipitate bronchospasm or induce attacks of asthma in susceptible subjects. High doses of aspirin may precipitate acute haemolytic anaemia in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency. Aspirin should be used with caution in patients with impaired renal or hepatic function (avoid if severe), or in patients who are dehydrated.

Nu-seals 300mg contains benzyl alcohol. High volumes should be used with caution and only if necessary, especially in patients with liver or kidney impairment because of the risk of benzyl alcohol accumulation and toxicity (metabolic acidosis).

Benzyl alcohol may also cause allergic reactions. Patients with hypertension should be carefully monitored. Nu-Seals should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

There is some evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. 6).

1. Hypoprothrombinaemia, haemophilia, haemorrhagic disease or a history of bleeding disorders, cerebral haemorrhage, and active peptic ulceration or a history of peptic ulceration. 6). 6).