SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Dispersible Aspirin Tablets BP 300mg Selles Soluble Aspirin Tablets BP 300mg Savory & Moore Dispersible Aspirin BP 300mg Tremletts Soluble Aspirin Tablets BP 300mg Cross & Herberts Soluble Aspirin Tablets BP 300mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Aspirin 300mg

3 PHARMACEUTICAL FORM

Dispersible tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of pain in headaches and menstruation and the symptomatic relief of colds, flu and feverishness.

4.2 Posology and method of administration

Route of Administration: Oral.

For adults, the elderly and children over 16 years:

One to three tablets to be taken dispersed in water every four hours if required. Maximum daily dose 12 tablets.

Children under 16 years:

Do not give to children under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).

4.3 Contraindications

Aspirin should be avoided or used cautiously in patients prone to dyspepsia or known to have or have ever had a stomach ulcer. It should not be given to patients with haemophilia or other haemorrhagic disorders or to patients with an intolerance to aspirin (especially aspirin or NSAID-sensitive asthmatics). Caution is necessary when renal or hepatic function is impaired.

4.4 Special warnings and precautions for use

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

Do not take if you have or have ever had a stomach ulcer.

Keep out of reach 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 aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).

4.5 Interaction with other medicinal products and other forms of interaction

Alcohol - effects on gastro-intestinal tract enhanced.

Antacids and adsorbents - excretion of aspirin increased in alkaline urine. Anticoagulants - increased risk of bleeding due to antiplatelet effect. Antiepilepticcs - enhancement of effects of phenytoin and sodium valproate. Cytotoxics - delayed excretion of methotrexate (increased toxicity).

Diuretics - antagonism of diuretic effect of spironolactone ; reduced excretion of acetazolamide (risk of toxicity).

Domperidone and metoclopramide - enhances effect of aspirin.

Uricosurics - effect of probenecid and sulphinpyrazone reduced.

4.6 Pregnancy and lactation

It should be used with caution in pregnancy especially in the first three months and should be avoided during lactation.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

The most common adverse effects are gastrointestinal disturbances such as nausea, dyspepsia and vomiting. Irritation of the gastric mucosa with erosion, ulceration, haematemesis and melaena may occur. Slight blood loss may occur in about 70% of patients but it is not usually of clinical significance except in long term therapy when it might cause iron-deficiency anaemia. Some persons, especially asthmatics, exhibit, notable sensitivity to aspirin. Aspirin increases the bleeding time, decreases platelet adhesiveness and in large doses may cause hypoprothrombinaemia.

4.9 Overdose

Symptoms

Dizziness, tinnitus, deafness, sweating, nausea, vomiting, headache and mental confusion. Also hyperventilation, fever, restlessness, ketosis and respiratory alkalosis and metabolic acidosis. Depression of the central nervous system may lead to coma, cardiovascular collapse and respiratory failure.

Treatment - Empty stomach by aspiration or gastric lavage. In cases of mild intoxication patients should drink plenty of fluid. In more severe intoxication, forced alkaline diureses may be required. Plasma electrolytes, especially potassium and the acid-base balance should be monitored regularly. Encouraging results have been obtained with repeated doses of oral suspensions of activated charcoal. In the presence of cardiac or renal impairment, haemodyalysis or haemoperfusion may need to be considered.

Pharmacodynamic properties

Aspirin possesses both analgesic and antipyretic properties.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric acid, anhydrous powder Maize starch, pregelatinised Maize starch Calcium carbonate Saccharin sodium Industrial methylated spirit.

6.2 Incompatibilities

None known.

Shelf life

36 months

6.4 Special precautions for storage

Store at or below 25°C.

6.5 Nature and contents of container

Polypropylene bottle or glass bottle with a child resistant closure containing 25, 50 or 100 tablets.

6.6 Special precautions for disposal

None.

7    MARKETING AUTHORISATION HOLDER

Ayrton Saunders Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0171

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 9/7/85 / 21/12/95

10 DATE OF REVISION OF THE TEXT

25/01/2011