Aspirin Tablets Bp 75mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dispersible Aspirin Tablets BP 75mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Aspirin 75mg For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Dispersible tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery.
4.2 Posology and method of administration
The advice of a doctor should be sought before commencing therapy for the first time.
Adults, the elderly and children 16 years or over:
The usual dosage, for long term use, 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.
Children under 16 years:
Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). See ‘4.4 Special Warnings and Special Precautions for Use’.
Method of Administration:
Dispersible Aspirin Tablets should be dissolved in a glass of water and taken orally.
4.3 Contraindications
Not to be given to children under 16 years unless specifically indicated (eg. for Kawasaki’s disease).
Other contraindications include active peptic ulceration, or a history of peptic ulceration, gout, breast feeding, haemophilia or other clotting disorders, concurrent anticoagulant therapy, hypersensitivity (e.g. bronchospasm, rhinitis, urticaria) to aspirin or to any of the other ingredients or non-steroidal anti-inflammatory drugs, and severe renal or hepatic impairment.
4.4 Special warnings and precautions for use
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 of aspirin versus the risks for the individual patient.
Administer with caution in the presence of allergic disease, renal or hepatic impairment, or dehydration. Aspirin may trigger haemolysis in patients with glucose-6-phosphate dehydrogenase deficiency.
There is a possible association between aspirin and Reye’s syndrome when give to children. Reye’s syndrome is a very rare disease when given to children with a fever. 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 (eg. for Kawasaki’s disease).
Aspirin should be avoided in late pregnancy and during breastfeeding (see section
4.6).
Dispersible Aspirin Tablets 75mg contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Elderly patients are more likely to experience gastrointestinal side effects and tinnitus.
Aspirin may induce gastro-intestinal haemorrhage, occasionally major. Patients with hypertension should be carefully monitored.
4.5 Interaction with other medicinal products and other forms of interaction
Aspirin antagonises the diuretic effect of some diuretics and may potentiate the effect of heparin, phenindione, antiepileptics such as phenytoin, insulin and sulphonylurea hypoglycaemic agents. It increases the risk of bleeding with anticoagulants (warfarin and acenocoumarol), increases the toxicity of methotrexate by delaying excretion, inhibits the effect of uricosurics (probenecid and sulfinpyrazone), increases risk of toxicity of acetazolamide by reducing excretion.
Antacids and corticosteroids reduce the effect of aspirin, metoclopramide potentiates the effect of acetylsalicylic acid.
Aspirin may also potentiate the effects and side effects of other non-steroidal antiinflammatory drugs.
Alcohol and corticosteroids may enhance the effects of aspirin on the gastrointestinal tract.
Principle incompatibilities are iron salts, carbonates and alkali hydroxides.
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 Fertility, pregnancy and lactation
Aspirin should not be taken during pregnancy, unless directed by a doctor. Aspirin is best avoided in late pregnancy and during breast-feeding as Aspirin may prolong labour and contribute to maternal and neonatal bleeding. Aspirin should be avoided during pregnancy and lactation as there is a risk of Reye's syndrome.
High doses of aspirin may result in closure of foetal ductus arteriosus in utero and possibly persistent pulmonary hypertension in the new born.
Kernicterus may be a consequence of jaundice in neonates.
Regular use of high doses could impair platelet function and produce hypothrombinaemia in the infant if neonatal vitamin K stores are low.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Side effects are not common and are mainly gastrointestinal e.g. dyspepsia, nausea, vomiting, diarrhoea and gastrointestinal bleeding which can lead to haemorrhage and perforation. Gastrointestinal irritation with slight asymptomatic blood loss, increased bleeding time, bronchospasm and skin reaction in hypersensitive patients have been reported.
Aspirin may induce attacks of asthma in susceptible subjects.
Can lead to hearing disturbances (such as tinnitus), vertigo or mental confusion.
Due to the effect on platelet aggregation, aspirin may be associated with an increased risk of bleeding.
Isolated cases of liver function disturbances and skin reactions have been reported. Aspirin and other NSAIDs may cause salt and water retention as well as a deterioration of renal function.
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. Healthcare professionals are asked to report any suspected adverse reactions via www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 am to 2 pm Mondays to Fridays).
4.9 Overdose
Overdosage is unlikely due to the low level of aspirin in the tablets.
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.
Overdose produces dizziness, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate, nausea and vomiting, confusion and hyperventilation. Some degree of acid-base disturbance is present in most cases. Gastric lavage and supportive therapy, restoration of acid-base balance may be necessary.
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 4 years. In children aged 4 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 of salicylate poisoning 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.
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 10 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
Pharmacotherapeutic group: B0lA C06
Aspirin is an inhibitor of the enzyme cyclo-oxygenase 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 400mg was taken within 8 hours before or within 30 minutes after immediate release aspirin (81mg), 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.
5.2 Pharmacokinetic 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 and salicylates are rapidly distributed to all body tissues; they appear in the milk and cross the placenta. The rate of excretion of aspirin varies as the pH rises and being greatest at pH 7.5 and above. Aspirin is also excreted as salicylic acid and as glucuronide conjugate and as salicyluric and gentisic acids.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which is additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch
Saccharin sodium Lactose Citric acid Calcium carbonate Talc
Sodium lauryl sulphate
6.2 Incompatibilities
None known.
6.3
Shelf life
36 months, as packaged for sale.
6.4 Special precautions for storage
Protect from heat, light and moisture.
6.5 Nature and contents of container
Opaque plastic containers composed of polypropylene tubes and polyethylene tamper-evident closures.
Opaque plastic containers composed of either high density polypropylene or high density polyethylene with a tamper evident or child resistant tamper evident closure composed of high density polyethylene with polyether foam or polyethylene or polypropylene filler.
Packs of aluminium/opaque PVC blisters in printed cartons Pack sizes of 24, 25, 50 100 and 1000
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Crescent Pharma Ltd
Units 3 and 4, Quidhampton Business Units
Polhampton Lane
Overton
Hampshire
RG25 3ED
United Kingdom
MARKETING AUTHORISATION NUMBER(S)
PL 20416/0227
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26 November 2004
10
DATE OF REVISION OF THE TEXT
14/08/2013