Dispersible Aspirin Tablets 75mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dispersible Aspirin Tablets 75mg BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg Aspirin
3 PHARMACEUTICAL FORM
White, flat, bevelled edged tablet.
Embossed with ‘ASP’ and ‘75’ on one side and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Dispersible aspirin 75mg tablets are indicated for the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery.
4.2 Posology and method of administration
For oral administration. The tablets should be dispersed in water before taking.
Adults
The advice of a doctor should be sought before commencing therapy for the first time. The usual dosage, for long term use, is 75 - 150 mg once daily.
In some circumstances a higher dose may be appropriate, especially in the short term, and up to 300mg a day may be used on the advice of a doctor.
Children under 16 years of age
Do not give to children under 16 years of age, unless specifically indicated (eg for Kawasaki’s disease).
4.3. Contra-indications
Aspirin is contra-indicated in peptic ulceration or history of peptic ulceration, gout, children under 12 (except under medical supervision for use for example in juvenile rheumatoid arthritis), breast feeding, haemophilia and where there is concurrent anti-coagulant therapy.
Hypersensitivity to aspirin or to any of the other ingredients.
4.4. Special Warnings and Precautions for Use
Before commencing long-term aspirin therapy for the management of cardiovascular or cerebrovascular disease patients should consult their doctor who can advise on the relative benefits versus the risks for the individual patient.
Administer with caution in the presence of allergic disease, renal or hepatic impairment and 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).
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
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.
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 of 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).
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
A high incidence of gastrointestinal irritation with slight asymptomatic blood loss and increased bleeding time have been reported. Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions in susceptible individuals. Aspirin can lead to hearing disturbances (such as tinnitus), vertigo or mental confusion and has been associated with Reye’s Syndrome in children.
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 the acid-base balance may be necessary.
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 enzyme cyclo-oxygenase which results in the inhibition of the biosynthesis of prostaglandins.
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 h before or within 30 min after immediate release aspirin dosing (81 mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of 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 milk and cross the placenta. The rate of excretion of 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 glucuronide conjugate as well 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 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
The tablets contain Starch, Lactose, Sodium Saccharin, Citric Acid Anhydrous, Calcium Carbonate, Talc and Sodium Lauryl Sulphate
6.2 Incompatibilities
None known
6.3 Shelf life
36 months
6.4 Special precautions for storage
For bottles, store in original container, keep container tightly closed. For blister packaging, store in original package, inside outer carton.
6.5 Nature and contents of container
HDPE or Snapsafe polypropylene containers with LDPE lids. Packs of 25, 50, 100 and 1000 tablets.
Child resistant Blister strips of 0.25mm PVC/ 35gsm Glassine (Pergamin) paper/ 0.009mm aluminium enclosed in a cardboard carton:
10, 14, 16, 20, 24, 28, 30, 32, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98 and 100 tablets.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
M & A Pharmachem Ltd Wigan Road Westhoughton Bolton BL5 2AL
8 MARKETING AUTHORISATION NUMBER(S)
PL 04077/0182
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20 June 2003
10 DATE OF REVISION OF THE TEXT
21/10/2011