Dispersible Aspirin 300mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
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
Prescription only packs:
As an analgesic, antipyretic and anti-inflammatory including use for rheumatoid arthritis, osteoarthritis and acute and chronic rheumatic conditions.
Pharmacy and GSL packs:
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. 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 warnings and precautions for use
Administer with caution in the presence of allergic disease, asthma, renal or hepatic impairment, 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).
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 probenacid and sulphinpyrazone, increases 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.
4.6 Pregnancy and lactation
Impaired platelet function and risk of haemorrhage. Kernicterus in jaundiced neonates. With regular use of high doses, closure of fetal ductus arteriosus in utero and possibly persistent pulmonary hypertension of the new born. Delayed onset and increased duration of labour with increasing blood loss. Avoid if possible in the last week of pregnancy.
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.
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 (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.
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
No 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, 16, 24 or 32 tablets.
Snapsafe vials and Tampertainers containing 8, 10, 12, 16, 25, 32, 50, 100, 500 or 1000 tablets.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Galpharm Healthcare Limited Hugh House Galpharm Way Upper Cliffe Road Dodworth Business Park Dodworth South Yorkshire S75 3SP
8 MARKETING AUTHORISATION NUMBER(S)
PL 16028/0019
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/03/1998 / 08/09/2010
10 DATE OF REVISION OF THE TEXT
08/09/2010