Aspirin 300mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aspirin 300mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aspirin 300mg
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round bi-convex tablets with no markings.
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
To be swallowed orally
Dosage: (products promoted only to the Medical Profession):
Adults, elderly and children over 16 years
Usual dose 300-1000 mg Maximum 4g daily in divided doses.
In acute rheumatic conditions up to 8g daily in divided doses.
Dosage: (products for sale direct to the public):
Adults, elderly and children over 16 years
Usual single dose 300 - 1000 mg.
Maximum daily dose 4g divided doses.
Dosage instructions should include:-
a. ) time intervals between doses (4-6 hours)
b. ) maximum daily dose in number of tablets (4 doses, 12 tablets)
Children
Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).
4.3 Contraindications
Contraindications: (products promoted only to the Medical Profession):
(i) Children under 16 years unless advised by a doctor
(ii) Active or a history of peptic ulceration
(iii) Haemophilia
(iv) Hypersensitivity to aspirin
Contraindications: (products for sale direct to the public):
“Do not take if you have a stomach ulcer”
4.4 Special warnings and precautions for use
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 aged under 16 years unless specifically indicated (e.g. for Kawasaki’s disease).
Caution should be exercised in patients with asthma, allergic disease, impairment of hepatic or renal function (avoid if severe) and dehydration.
Do not take if you have a stomach ulcer.
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 reach of children.
Do not give to children under 16 years of age unless your doctor tells you to.
4.5 Interaction with other medicinal products and other forms of interaction
(i) May enhance the effects of anticoagulants, and oral hypoglycaemic agents.
(ii) May enhance the effects of phenytoin and sodium valproate.
(iii) The activity of methotrexate may be markedly enhanced and its toxicity increased.
(iv) May inhibit action of uricosurics.
(v) The toxicity of sulphonamides may also be increased.
(vi) May reduce the efficacy of antihypertensive drugs.
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
Aspirin does not usually affect the ability to drive or operate machinery.
4.8 Undesirable effects
Aspirin may precipitate bronchospasm, and induce attacks of asthma in susceptible subjects. It may induce gastro-intestinal haemorrhage, occasionally major.
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 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 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 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 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
5.1 Pharmacodynamic properties
Aspirin is an analgesic and antipyretic with anti-inflammatory properties. Aspirin inhibits prostaglandin synthetase.
5.2 Pharmacokinetic properties
Absorption:
Aspirin is rapidly absorbed after oral administration, with hydrolysis to salicylate before absorption. Absorption is delayed by the presence of food and is impaired in patients suffering migraine attacks. Absorption is more rapid in patients with achlorhydria and also following administration of polysorbates and antacids.
Blood Concentration:
Peak plasma concentration of approximately 45 g/ml are attained 1 to 2 hours after an oral dose of 640 mg, but stabilise at approximately 270 g/ml after oral doses of 3g daily. After an oral dose of about 2g, peak plasma concentrations of approximately 15 g/ml of aspirin are attained in about one hour and peak plasma concentrations of approximately 130 g/ml of salicylate are attained in 2 to 4 hours.
Half Life:
Plasma / Aspirin Approximately 17 minutes
Plasma Salicylate Low doses 2-4 hours
High doses up to 19 hours
Distribution:
Aspirin is found in the saliva, milk, plasma and synovial fluid at concentrations less than blood and crosses the placenta.
Salicylate/extensive protein binding.
Aspirin/protein binding to a small extent.
Metabolism:
In the blood, rapid hydrolysis to salicylic acid; glucuronic acid/glycine conjugation to form glucuronides and salicyluronic acid; oxidation of a small proportion.
Excretion:
Excreted in the urine mainly as salicyluronic acid. Salicylate reabsorbed by renal tubules in acid urine, and alkaline diuresis will increase the rate of excretion; 85% of dose excreted as free salicylate.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize Starch
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Blister strip - Do not store above 25 C. Store in the original package.
Tablet container - Do not store above 25 C. Store in the original container. Keep the container tightly closed.
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 16, 24, 32 or 100 tablets.
or
Tablet container (PP-Polypropylene) with child resistant closure (LDPE-Low density Polyethylene) containing 16, 25, 32, 50, 100, 500 or 1000 tablets.
6.6 Special precautions for disposal
N/A
7 MARKETING AUTHORISATION HOLDER
Galpharm Healthcare Limited
Hugh House
Upper Cliffe Road
Dodworth Business Park
Dodworth
Barnsley
South Yorkshire
S75 3SP
8 MARKETING AUTHORISATION NUMBER(S)
PL 16028/0046
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28th November 2001
10 DATE OF REVISION OF THE TEXT
August 2010 (Change to section 1).