Aspirin 75mg Dispersible Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aspirin 75 mg Dispersible Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg Aspirin Ph. Eur.
3. PHARMACEUTICAL FORM
White, flat, bevelled edged tablets engraved 2D4 on one side and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Aspirin tablets are indicated for the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following bypass surgery.
4.2 Posology and method of administration
For oral administration.
The advice of a doctor should be sought before commencing therapy for the first time.
Adults:
The usual dosage, for long term use, is 1 - 2 tablets once daily. In some circumstances a higher dose may be appropriate, especially in the short term, and up to 4 tablets daily may be used on the advice of a doctor.
Do not give to children under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).
4.3 Contraindications
Aspirin is contra-indicated in peptic ulceration or a history of peptic ulceration, gout, children under 16 (except under medical supervision for use for example in juvenile rheumatoid arthritis), breast-feeding, haemophilia and where there is concurrent anticoagulant therapy.
4.4 Special warnings and precautions for use
Administer with caution in the presence of allergic disease, renal or hepatic impairment and dehydration.
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. for Kawasaki’s disease).
Before commencing long term aspirin therapy for the management of cardiovascular or cerebrovascular disease, patients should consult their doctor who can advise on the relative benefits versus the risks for the individual patient.
4.5 Interaction with other medicinal products and other forms of interaction
Aspirin antagonises the diuretic effect of spironolactone, potentiates the effect of heparin, increases the risk of bleeding with warfarin and nicoumalone, increases the toxicity of methotrexate by delaying excretion, inhibits the effect of probenecid and sulphinpyrazone, and increases the risk of toxicity of acetazolomide by reducing excretion. Antacids and corticosteroids reduce the effect of aspirin. Metoclopramide potentiates the effect of aspirin.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and
no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
4.6 Pregnancy and lactation
Do not administer at term or during lactation.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
A high incidence of gastrointestinal irritation with slight asymptomatic blood loss and increased bleeding time have been reported. Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions in susceptible individuals. Aspirin can lead to hearing disturbances (such as tinnitus), vertigo, or mental confusion and has been associated with Reye's Syndrome in children.
4.9 Overdose
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
Symptoms
Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.
Management
Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Absorption of non-ionised aspirin occurs in the stomach. Acetylsalicylates and salicylates are also readily absorbed from the intestine. Hydrolysis to salicylic acid occurs rapidly in the intestine and in the circulation. Salicylates are extensively bound to plasma proteins; aspirin to a lesser degree. Aspirin is an inhibitor of enzyme cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after immediate release aspirin (81 mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.
Pharmacokinetic properties
5.2
Aspirin and salicylates are rapidly distributed to all body tissues; they appear in milk and cross the placenta. The rate of excretion of aspirin varies with the pH of the urine, increasing as the pH rises and being greatest at pH 7.5 and above. Aspirin is also excreted as salicylic acid and as glucuronide conjugate as well as salicyluric and gentisic acids.
5.3 Preclinical safety data
Preclinical information has not been included because the safety profile of Aspirin has been established after many years of clinical use. Please refer to section 4.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
The tablets contain Starch Ph. Eur., Sodium Saccharin Ph. Eur., lactose granules, Citric Acid Anhydrous BP, Calcium Carbonate Ph. Eur., Talc Ph. Eur. and Sodium Lauryl Sulphate Ph. Eur.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4
Special precautions for storage
Protect from heat, light and moisture.
6.5 Nature and contents of container
GSL packs: P packs:
POM packs:
Blister packs of 16 tablets.
Blister packs of 24, 30 or 32 tablets.
Polypropylene or HDPE containers with LDPE lids in packs of 25, 50 or 100 tablets.
Polypropylene or HDPE containers with LDPE lids in packs of 1000 tablets.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
TEVA UK Ltd,
Brampton Road Hampden Park Eastbourne BN22 9AG England.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/0229
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 04 Febuary 1992 / 03 November 1998
10 DATE OF REVISION OF THE TEXT
14/01/2009