Aspirin Tablets Bp 300mg
Out of date information, search anotherPRODUCT SUMMARY
1. NAME OF THE MEDICINAL PRODUCT Aspirin Tablets BP 300mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg Aspirin
3. PHARMACEUTICAL FORM
Compressed tablet.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
As an analgesic, antipyretic and anti-inflammatory for the relief of mild to moderate pain including headache, migraine, neuralgia, sore throat, period pain, aches and pains.
Also symptomatic relief of influenza, feverishness and feverish colds.
4.2 Posology and method of administration
This preparation is intended for oral administration.
Adults and children over 16 years of age: 1 to 3 tablets with or after food every four hours up to a maximum of 12 tablets a day.
Children: Do not give to children aged under 16 years, unless specifically indicated (eg for Kawasaki’s disease).
4.3 Contra-indications
Aspirin is contraindicated in patients with active peptic ulceration or a history of peptic ulceration.
Aspirin is contraindicated in gout, breast feeding, haemophilia, and concurrent anticoagulant therapy.
4.4 Special warnings and precautions for use
Administer with caution in the presence of allergic disease, renal or hepatic impairment, dehydration.
There is a possible association between aspirin and Reyes 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 aged under 16 years unless specifically indicated (eg for Kawasaki ‘s disease).
4.5. Interaction with other medicinal products and other forms of interaction
Aspirin antagonises the diuretic effect of spironolactone, potentiates the effect of heparin, increases the risk of bleeding with warfarin and acenocoumarol, increases the toxicity of methotrexate by delaying excretion, inhibits the effect of probenecid and sulfinpyrazone and increases the risk of toxicity of acetazolomide by reducing excretion. Antacids and corticosteroids reduce the effect of aspirin. Metoclopramide potentiates the effect of aspirin.
Concurrent administration of aspirin with other drugs that are known to increase bleeding time, for example anticoagulants and antiplatelet drugs such as clopidrogel and ticlopidine, or that are known to cause gastrointestinal irritation, for example NSAIDs, may increase the risk of haemorrhage and other gastrointestinal side effects.
4.6 Pregnancy and lactation
Do not administer at term or during lactation.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
High incidence of gastro-intestinal irritation with slight asymptomatic blood loss, increased bleeding time, bronchospasm and skin reaction in hypersensitive patients. Association with Reye's Syndrome in children. Can lead to hearing disturbances (such as tinnitus), vertigo or mental confusion.
Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions in susceptible individuals.
Other undesirable effects include:
Gastrointestinal ulceration, haematemesis, melaena, iron-deficiency anaemia, gastrointestinal bleeding
4.9 Overdose
Employ gastric lavage, forced alkaline diuresis and supportive therapy. Restoration of acid-base balance may be necessary.
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 enzyme cyclo-oxygenase which results in the inhibition of the biosynthesis of prostaglandins.
5.2 Pharmacokinetic properties
Aspirin and salicylates are rapidly distributed to all body tissues; they appear in milk and cross the placenta. The rate of excretion of the aspirin varies with the pH of the urine, increasing as the pH rises and being greatest at pH 7.5 and above. Aspirin is also excreted as salicylic acid and as the glucuronide conjugate and as salicyluric and gentisic acids.
5.3 Preclinical safety data
Preclinical information has not been included because the safety profile of Aspirin has been established after many years of clinical use. Please refer to section 4.
6.1 List of excipients
Each tablet contains Maize Starch.
6.2 Incompatibilities
None known.
6.3 Shelf life
The shelf life of the product is 36 months when stored in glass or plastic container or in paper / aluminium / PVC blister packs.
6.4 Special precautions for storage
For glass and plastic bottles, store in original container, keep container tightly closed.
For blister packaging, store in original package, inside outer carton.
Store in a dry place at a temperature not exceeding 25°C.
6.5 Nature and contents of container
Amber glass bottle with white ‘clic-loc’ CRC, BK steran liner:
16, 25, 32, 48, 50, 96 and 100 tablets.
Grey plastic securitainer tub with tamper evident plastic security cap:
500 and 1000 tablets.
Plastic Snape-Safe vial with snap-safe CRC:
16, 25, 32, 48, 50, 96 and 100 tablets.
HDPE container with a plastic tamper-evident lid:
16, 25, 32, 48, 50, 96, 100, 250, 500 and 1000 tablets.
HDPE vial with plastic press-on child resistant lid:
16,25, 32,48, 50, 96 and 100 tablets.
5L HDPE bucket with HDPE lid (air-tight lid) and a 150G polythene bag with a tape seal:
10000, 20000, 30000, 40000 and 50000 tablets.
Corrugated cardboard carton with a double 105G polythene bag and tape seal: 10000, 20000, 30000, 40000 and 50000 tablets.
Child Resistant Blister pack strips, 0.25mm PVC/35 gsm glassine (Pergamin) paper/0.009mm aluminium enclosed in a cardboard carton:
10, 12, 16, 20, 24, 32, 48, 96 and 100 tablets.
6.6 Instructions for use/handling
Not applicable.
7. MARKETING AUTHORISATION HOLDER
M & A Pharmachem Limited.
Allenby Laboratories,
Wigan Road,
Westhoughton,
Bolton BL5 2AL
8. MARKETING AUTHORISATION NUMBER
PL 04077/0025
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Granted 22 June 1982 / Renewed 22 June 1987 & 22 June 1992.
10 DATE OF REVISION OF THE TEXT
21/10/2011