Summary of medicine characteristics - DISPERSIBLE ASPIRIN TABLETS BP 300 MG, DISPERSIBLE ASPIRIN 300 MG TABLETS
1 NAME OF THE MEDICINAL PRODUCT
Dispersible Aspirin Tablets BP 300mg
Dispersible Aspirin 300 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aspirin BP 300 mg
3 PHARMACEUTICAL FORM
Tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness. For mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains and for the symptomatic relief of influenza, feverishness and feverish colds.
4.2 Posology and method of administration
For oral administration.
Adults and the elderly: 1 to 3 tablets every four hours if necessary.
Up to a maximum of 12 tablets in any 24 hour period.
Children: Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).
4.3 Contraindications
Active peptic ulceration or a history of peptic ulceration, gout, breast-feeding, haemophilia, concurrent anti-coagulant therapy, asthma, pregnancy at term and severe renal and hepatic disease.
4.4 Special warning and precautions for use
Administer with caution in the presence of allergic disease, asthma, renal or hepatic impairment, dehydration.
The product labelling will include:
If you are receiving regular medical treatment, are asthmatic, allergic to aspirin or have or have had a stomach ulcer, seek your doctor’s advice before taking this product.
If symptoms persist for more than 3 days consult your doctor.
Medicines should not be taken in pregnancy without consulting your doctor.
Keep out of the sight and reach of children.
Do not give to children under 16 years of age unless your doctor tells you to.
There is a possible association between aspirin and Reye's syndrome 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 (e.g. for Kawasaki’s disease).
Contains Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other Medicinal Products and other forms of Interaction
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, increases the risk of toxicity of Acetazolamide by reducing excretion. Antacids and corticosteroids reduce the effect of Aspirin, Metoclopramide and Domperidone potentiates the effect of Aspirin. Aspirin enhances the effect of Phenytoin and Sodium Valproate.
Aspirin may enhance the effects of oral hypoglycaemia agents. The toxicity of sulphonamides may also be increased. Aspirin may reduce the efficacy of antihypertensive drugs.
Aspirin may enhance the effects of anticoagulants and inhibit the effects of uricosurics.
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 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).
Mifepristone: The manufacturer of mifepristone recommends that aspirin should be avoided until eight to twelve days after mifepristone has been discontinued.
Combinations requiring precautions for use or to be taken into account Cilostazol, mifepristone, sibutramine, SSRIs and venlafaxine, zafirlukast. SSRIs -increased risk of gastrointestinal bleeding
4.6 Pregnancy and Lactation
There is clinical and epidemiological evidence of safety in human pregnancy.
Aspirin may prolong labour and contribute to maternal neonatal bleeding, and is best avoided at term and during breast feeding – possible risk of Reye’s syndrome.
Regular use of high doses could impair platelet function and produce hypoprothrombinaemia 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
Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions in susceptible individuals. High incidence of gastrointestinal irritation with slight symptomatic blood loss, increases bleeding time. Can lead to hearing disturbances (such as tinnitus), vertigo or mental confusion. May also induce gastrointestinal haemorrhage, occasionally major.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisations 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 the Yellow Card Scheme at: www.mhra/…k/yellowcard.
4.9 Overdose
4.9 OverdoseSalicylate 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 (95.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
Symptoms
Common feature include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with pounding 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 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 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 children.
Management
Give active 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 the poisoning cannot be determined from this alone and the clinical biochemical features must be taken into account. Elimination is increased by urinary alkalisation, 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 salycilate 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
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 the biosynthesis of prostaglandins.
Aspirin inhibits the cyclo-oxygnease enzyme involved on conversion of phospholipids to prostaglandins and its effects on the body are believe to result primarily from prevention of prostaglandin production. These effects include peripheral analgesia, fever reduction, reduction in inflammation and inhibition of platelet aggregation.
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 dosing (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 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
Aspirin and salicylates are rapidly distributed to all body tissues, they appear in breast milk and cross the placenta. The rate of excretion of aspirin varies as the pH rises being greatest at pH 7.5 and above. Aspirin is also excreted as salicylic acid, glucuronide conjugate and as salicyluric and gentisic acids.
5.3 Preclinical safety data
5.3 Preclinical safety dataNo additional data provided. The pre-clinical safety of aspirin is already well documented.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Starch
Sodium Saccharin
Lactose Anhydrous
Anhydrous Citric Acid Calcium Carbonate
Purified Talc
Sodium Lauryl Sulphate
6.2 Incompatibilities
None.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 25°C in a dry place and protect from light.
6.5 Nature and contents of container
Blister strips comprised of 30micron hard temper Aluminium lidding foil with 250 – 300micron PVC base material.
or
Blister strips comprised of 30micron hard temper Aluminium lidding foil with 250 micron PVC/PVdC (40–90gsm) base material. or
Blister strips comprised of 20micron Aluminium/15micron PVC lidding foil with 250 – 300micron PVC base material.
or
Blister strips comprised of 20micron Aluminium/15micron PVC lidding foil with 250micron PVC/PVdC (40– 90gsm) base material.
or
Blister strips comprised of 35–41gsm Glassine paper/9micron Aluminium lidding foil with 250 – 300micron PVC base material.
or
Blister strips comprised of 35–41gsm Glassine paper/9micron Aluminium lidding foil with 250micron PVC/PVdC (40–90gsm) base material.
Blister pack sizes of 8, 10, 12 or 16 tablets.
Snapsafe vials and Tampertainers containing 8, 10, 12 or 16 tablets
6.6 Special precautions for disposal
7. MARKETING AUTHORISATION HOLDER
8 MARKETING AUTHORISATION NUMBER(S)
PL 16028/0019
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/03/1998 / 08/09/2010