Dispersible 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Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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
Dispersible Aspirin Tablets contain 75 mg of Aspirin B.P.
Also contains lactose. For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Compressed Tablets
White, flat circular tablets with bevel edge.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
This medicine is used to help prevent heart attacks and strokes in patients who have suffered from these previously. It can also be used to help prevent further heart disease in patients suffering from unstable angina and following bypass surgery or for the secondary prevention of thrombic cerebrovascular disease.
4.2 Posology and method of administration
Route of administration:
Dose is dispersed in water and given orally.
The advice of doctor should be sought before commencing therapy for the first time.
Adults, the elderly and children 16 years or over:
The usual dosage, for the 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 doctor.
Children under 16 years:
Do not give to children under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). See ‘4.4 Special Warnings and Special Precautions for Use’.
4.3 Contraindications
Not to be given to children under 16 years unless specifically indicated (eg. For Kawasaki’s disease).
Do not give to patients known to be allergic to aspirin or suffering from peptic ulceration, gout, breast feeding, or a previous history of peptic ulceration, haemophilia or other clotting disorders and concurrent anticoagulant therapy. Asthma, bronchospasm, urticaria, rhinitis or other evidence of hypersensitivity to aspirin or to any of the other ingredients to aspirin or non steroidal anti-inflammatory drugs and severe renal or hepatic impairment.
4.4 Special warnings and precautions for use
Do not exceed stated dose except under medical advice and supervision of a doctor.
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 given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason it 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 doctors who can advice on the relative benefit versus the risk for the individual patient.
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. Aspirin may enhance the effects of anticoagulants and increase the toxicity of sulphonamides.
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
The use of analgesic doses of aspirin during pregnancy, particularly during the third trimester, should be avoided unless directed by a doctor. The drug may change maternal and newborn haemostatic mechanisms, leading to an increased risk of haemorrhage. Aspirin may also delay the onset and increase the duration of labour and contribute to maternal and neonatal bleeding. With high doses, there may be premature closure of foetal ductus arteriosus in utero and possibly pulmonary hypertension in the new born. Kernicterus may be a consequence of jaundice in neonates.
The use of low doses of aspirin, for the secondary prevention of myocardial infarction and stroke are probably not harmful.
Regular use of high doses could impair platelet function and produce hypothrombinaemia in the infant if neonatal vitamin K stores are low.
Aspirin is secreted into breast milk in low concentration and should consequently be avoided during lactation because of the possible risk of Reye's Syndrome and the fact that high doses could potentially impair platelet function.
No Data Held
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. Less commonly irritation of the gastrointestinal mucosa may lead to erosion, ulceration, asymptomatic blood loss, increased bleeding time, bronchospasm and skin reaction in hypersensitive patients have been reported. Hypersensitivity reactions including urticaria, rhinitis, angioneurotic oedema have also been reported.
Aspirin may precipitate bronchospasm and induce asthma attacks 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.
4.9 Overdose
Overdosage is unlikely due to the low level of aspirin in the tablets.
Salicylate poisoning is usually connected with plasma concentrations >350mg/L (2.5mmol/L). Most adult deaths arise in patients whose concentrations go beyond 700 mg/L (5.1mmol/L). Single doses less than 100mg/kg are suspect to cause serious poisoning.
Symptoms
Frequent type of salicylate poisoning include dehydration, tinnitus, dizziness, vomiting, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate, nausea, confusion and hyperventilation. Some point of acid-base disturbance is present in the majority of 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, thrombocytopenia, 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 250mg/kg. The plasma salicylate concentration should be calculated, 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 >700mg/L (5.1mmol/L), or lower concentrations connected with severe clinical or metabolic type. Patients under 10 years or over 70 have increased risk of salicylate toxicity and may need dialysis at an earlier stage. Restoration of acid base balance may be necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: B0lA C06
Aspirin has analgesic, antipyretic and anti-inflammatory actions which are considered to be due to inhibition of the synthesis of prostaglandins.
Aspirin also inhibits platelet aggregation by irreversible acetylation of platelet cyclooxygenase.
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 and intestine. Some aspirin is hydrolysed to salicylate in the gut wall. After absorption aspirin is quickly converted to salicylate but during the first 20 minutes following oral administration, aspirin is the predominant form of the drug in the plasma. Aspirin is bound to plasma proteins and is extensively distributed. Plasma aspirin concentrations decline speedily (half life 15-20 minutes) as plasma salicylate concentrations increase.
Salicylate is mainly eliminated by hepatic metabolism the metabolites including salicylic acid, salicyl phenolic glucuronide, salicylic acyl glucuronide, gentisic acid and gentisuric acid. As a result of zero order kinetics, plasma steady state salicylate concentrations increase disproportionately with dose. Salicylate is also excreted unchanged in the urine to an extent which depends on the dosage and urinary pH. Renal excretion involves glomerular filtration, active renal tubular secretion and passive tubular reabsorption.
5.3 Preclinical Safety Data
Not applicable.
Pharmaceutical properties
6.1 List of excipients
|
Citric Acid |
7.5 mg |
|
Calcium Carbonate |
25 mg |
|
Saccharin Sodium |
0.75 mg |
|
Anhydrous Lactose |
27.5 mg |
|
Maize Starch |
12.5 mg |
|
Purified Talc |
1.62 mg |
|
Sodium Lauryl Sulphate |
0.13 mg |
6.2 Incompatibilites None Stated
No Data Held
6.3 Shelf life
2 Years
6.4 Special precautions for storage
Store in a cool, dry place protected from bright light.
6.5 Nature and contents of container
Dispensing pack: A polypropylene container with snap lid. Supplied in packs of 250, 500 and 1000. (POM)
OTC packs: A polypropylene container with snap lid. Supplied in packs of 24, 25, 50 and 100. (P)
GSL packs: A polypropylene container with snap lid. Supplied in packs of 12, 16. (GSL)
Not all pack sizes may be marketed
6.6 Special precautions for disposal
Dose is dispersed in water and given orally.
7 MARKETING AUTHORISATION HOLDER
Pharmvit Limited 177 Bilton Road,
Perrivale
Greenford
Middlesex UB6 7HQ
8. MARKETING AUTHORIZATION NUMBER(S)
PL 4556/0013
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
21/11/1990/ 5th August 2009
10 DATE OF REVISION OF THE TEXT
07/11/2014