Aspirin Tablets Bp 300mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aspirin Tablets BP 300mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aspirin 300mg
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet.
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.
Mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains.
4.2 Posology and method of administration
To be swallowed orally.
Usual single dose 300 - 1000mg.
Maximum daily dose 4g in 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)
Do not give to children under 16 years, unless specifically indicated (e.g. Kawasaki’s disease).
4.3 Contraindications
"Do not take if you have a stomach ulcer"
4.4 Special warnings and precautions for use
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, or have had, 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 on the advice of your doctor.
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, unless specifically indicated (e.g. Kawasaki’s disease).
4.5 Interaction with other medicinal products and other forms of interaction
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(i) |
May enhance the effects of anticoagulants, and oral hypoglycaemic agents. |
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(ii) |
May enhance the effects of phenytoin and sodium valproate. |
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(iii) |
The activity of methotrexate may be markedly enhanced and its toxicity increased. |
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(iv) |
May inhibit action of uricosurics. |
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(v) |
The toxicity of sulphonamides may also be increased. |
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(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 and 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
Dizziness, tinnitus, deafness, vasodilation and sweating, nausea and vomiting, headache and mental confusion. If more severe, hyperventilation, fever, restlessness ketosis, respiratory alkalosis, metabolic acidosis.
Coma, if severe, with cardiovascular collapse and respiratory failure. Hypoglycaemia may be severe in children.
Main points are gastric lavage, forced alkaline diuresis and supportive therapy. Restoration of acid-base balance may be necessary.
5 PHARMACOLOGICAL PROPERTIES
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 some 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 concentrations of approximately 45
mcg/ml are attained 1-2 hours after an oral dose of 640mg, but stabilise at approximately 270 mcg/ml after oral doses of 3g daily. After an oral dose of about 2g, peak plasma concentrations of approximately 15mcg/ml of aspirin are attained in about one hour and peak plasma concentrations of approximately 130mcg/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 building.
Aspirin/protein binding to a small extent.
Metabolism: In the blood, rapid hydrolysis to salicylate 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 B.P.
6.2 Incompatibilities
Aspirin is pharmaceutically incompatible with iron salts and alkalis.
6.3 Shelf life
36 Months.
6.4 Special precautions for storage
Do not store above 25 °C and protect from light.
6.5 Nature and contents of container
Blister packs (PVC) of 16, 24, 32 tablets
Tablet containers of 16, 25, 32 tablets
6.6 Special precautions for disposal
N/A
7 MARKETING AUTHORISATION HOLDER
Zanza Laboratories (Holdings) Limited
Unit 2A
Olympic Way
Sefton Business Park
LIVERPOOL
L30 1RD
8 MARKETING AUTHORISATION NUMBER(S)
PL 39874/0022
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7 July 2004
10 DATE OF REVISION OF THE TEXT
15/11/2011