Dispersible Aspirin Tablets Bp 75mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dispersible Aspirin Tablets BP 75 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg Aspirin PhEur.
3 PHARMACEUTICAL FORM
White uncoated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease, following by-pass surgery and in patients suffering from unstable angina.
4.2 Posology and method of administration
Posology
The tablets should be dispersed in water before administration.
The advice of a doctor should be sought before commencing therapy for the first time.
Adults: The usual dosage for long term use is 1-2 tablets (75-150mg) once daily. In some circumstances a higher dose may be appropriate, especially in the short-term, and up to 4 tablets (300mg) a day may be used on the advice of a doctor.
Children: Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).
Method of Administration
To be dispersed in water for oral administration.
4.3 Contraindications
Aspirin should not be taken by patients with the following conditions:
• Known hypersensitivity to aspirin, other ingredients in the product, other salicylates or non-steroidal anti-inflammatory drugs (a patient may have developed anaphylaxis, angioedema, asthma, rhinitis or urticaria induced by aspirin or other NSAIDs). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine, as it contains lactose.
• Nasal polyps associated with asthma (high risk of severe sensitivity reactions).
• Active peptic ulceration or a past history of peptic ulceration or dyspepsia.
• Haemophilia or other haemorrhagic disorder (including thrombocytopenia) as there is an increased risk of bleeding.
• Concurrent anticoagulant therapy should be avoided.
• Severe hepatic impairment
• Severe renal impairment
• Severe cardiac failure
• third trimester of pregnancy
• children under 16 years old, unless specifically indicated (e.g. Kawasaki’s disease).
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.
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).
Aspirin should be used with caution in patients with:
• allergic disease
• anaemia (may be exacerbated by GI blood loss)
• asthma (increased risk of bronchospastic sensitivity reactions)
• cardiac failure (conditions which predispose to fluid retention)
• dehydration
• glucose-6-phosphate dehydrogenase deficiency (aspirin rarely causes haemolytic anaemia)
• gout (serum urate may be increased)
• hepatic function impairment (avoid if severe)
• renal function impairment
• surgery. Aspirin should be discontinued several days before scheduled surgery (including dental extractions)
• systemic lupus erythematosus and other connective tissue disorders (hepatic and renal function may be impaired in these conditions)
• thyrotoxicosis (may be exacerbated by large doses of salicylates)
• long term use in elderly patients should be avoided due to a risk of gastrointestinal bleeding.
• Vaccine recipients should avoid use of salicylates for 6 weeks after varicella vaccination (see section 4.5).
• the following warnings are on the OTC product labelling:
Do not give to children aged under 16 years, unless on the advice of a doctor.
Medicines should not be taken in pregnancy without consulting your doctor Do not take if you have or have had a stomach ulcer If symptoms persist, consult your doctor Keep out of the reach of children
Asthmatics should consult their doctor before using this product
Your doctor’s advice should be sought before starting long-term aspirin
treatment
4.5 Interactions with other Medicaments and other forms of Interaction
The following drug interactions should be considered when prescribing
aspirin:
• Alcohol - may enhance gastro-intestinal side effect of aspirin.
• Analgesics - avoid concomitant administration of other salicylates or other NSAIDs (including topical formulations) as increased risk of side effects.
• Alkalizers of urine (eg carbonic anhydrase inhibitors, antacids, citrates) -increased excretion of aspirin.
• Anticoagulants or platelet aggregation inhibitors - increased risk of bleeding.
• Antiepileptic drugs (eg phenytoin, sodium valproate) - increased effect.
• Corticosteroids - increased risk of gastro-intestinal bleeding or ulceration.
• Dipyridamole - increase in peak concentration.
• Diuretics - frusemide and acetazolamide (risk of toxic effects), spironolactone (antagonized diuretic action).
• Hypoglycaemics - enhanced activity.
• Methotrexate - increased toxicity.
• Metoclopramide and domperidone - increased rate of absorption of aspirin.
• Mifepristone - avoid aspirin until 8-12 days after mifepristone.
• Ototoxic medicine (eg vancomycin) - potential for ototoxicity increased. Hearing loss may occur and may progress to deafness even after discontinuation of the medication. Effects may be reversible but are usually permanent.
• Uricosurics (eg probenecid, sulphinpyrazone) - effects of uricosurics reduced.
• Laboratory investigations - aspirin may interfere with some laboratory tests such as urine 5-hydroxyundoleacetic acid determinations and copper sulphate urine sugar tests.
• ACE inhibitors - reduced hypotensive effect, increased risk of renal impairment and hypokalaemia. Monitoring of renal function may be required.
• Calcium-channel blockers - reduced hypotensive effects, increased antiplatelet effect which rarely results in pro-longed bleeding time.
• SSRIs - increased risk of gastrointestinal bleeding
• Varicella vaccine - Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with varicella vaccine as Reye's syndrome has been reported following use of salicylates during wild-type varicella infection (see section 4.4).
• Ginkgo Biloba - possible increase in risk of bleeding.
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).
4.6 Pregnancy and Lactation
Pregnancy
Inhibition of prostaglandin sysnthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiology studies suggest an increased risk of miscarriage and of cardiac malformation after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%.
Studies in animals have shown that salicylates can cause birth defects including fissure of the spine and skull, facial clefts and malformations of the CNS, viscera and skeleton, pre and post implantation loss and embryo-fetal lethality. During the first and second trimester aspirin should not be given unless necessary.
Regular or high dose use of salicylates late in pregnancy may result in:
- constriction or premature closing of the fetal ductus arteriosus
- increased risk of still birth or neonatal death
- decreased birth weight
- prolonged labour
- complicated deliveries and increased risk of maternal or fetal haemorrhage
- possibly persistent pulmonary hypertension of newborn
- kernicterus in jaundiced neonates
- renal dysfunction, which may progress to renal failure with oligo-hydramniosis
Administration is contraindicated in the last trimester of pregnancy and should be avoided during the late stages of labour and during the delivery of a premature infant.
Breastfeeding
Use in children under 16 years old is contraindicated due to possible risk of Reye’s syndrome. Since aspirin is distributed into breast milk, breast fed infants may also be at risk. Aspirin should be avoided while breastfeeding.
Fertility
Aspirin should not be given to women wishing to become pregnant, since it is thought that prostaglandin synthesis inhibitors can reduce fertility. The effect on fertility is reversible.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable Effects
Blood and lymphatic system disorders - anaemia, haemolytic anaemia, hypoprothrombinaemia, thrombocytopenia, aplastic anaemia, pancytopenia, prolonged bleeding time, occult blood loss, elevated transaminase levels, agranulocytosis.
Gastrointestinal disorders - gastrointestinal bleeding, erosions, perforations or ulceration which can occasionally be major (may develop bloody or black tarry stools, severe stomach pain and vomiting blood), gastrointestinal irritation (mild stomach pain, heartburn, vomiting and nausea). Fatalities have occurred.
Hepatic disorders - hepatitis (particularly in patients with SLE or connective tissue disease).
Renal and urinary disorders - disturbances of renal function Ear and labyrinth disorders - tinnitus.
Salicylism - mild chronic salicylate intoxication may occur after repeated administration of large doses, symptoms include dizziness, tinnitus, deafness, sweating, nausea, vomiting, headache and mental confusion, and may be controlled by reducing the dose.
General disorders and administration site conditions - Allergic reactions -rhinitis, urticaria, purpura, Stevens-Johnson syndrome, angioneurotic oedema, angio-oedema, asthma, worsening of asthma, bronchospasms.
Children
Aspirin may be associated with the development of Reye’s Syndrome (encephalopathy and hepatic failure) in children presenting with an acute febrile illness.
4.9 Overdose Symptoms:
Common features:
Salicylates cause nausea, vomiting, tinnitus, lethargy or dizziness in mild poisoning. Dehydration, restlessness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation occur in moderate poisoning. Some degree of acid-base disturbance is present in most cases.
Uncommon features:
Haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, disseminated intravascular coagulation, renal failure and non-cardiogenic pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children
Treatment:
Consider oral activated charcoal (50g for an adult, 1g/kg for a child) in adults and children who have ingested more than 125mg/kg body weight salicylate, or any amount of methyl salicylate, less than 1 hour previously.
Consider gastric lavage in adults and children who have ingested more than 500 mg/kg body weight salicylate less than 1 hour previously.
Plasma salicylate, U & Es, INR/PTR, blood glucose, pH and electrolytes should be measured.
Fluid losses replaced and forced alkaline diuresis (eg with sodium bicarbonate) should be considered when the plasma salicylate concentration is greater than 500mgl-1 (3.6mmol l-1) in adults or 300mgl-1 (2.2mmol l-1 ) in children.
In very severe cases of poisoning haemodialysis may be needed.
5.1 Pharmacodynamic properties
ATC code: N02BA01
Aspirin is an anti-inflammatory analgesic and antipyretic.
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 hours before or within 30 minutes after immediate release aspirin
(81mg), a decreased effect of aspirin 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.
Pharmacokinetic properties
5.2
Absorption of non-ionised aspirin occurs in the stomach and intestine. Some aspirin is hydrolysed to salicylate in the gut wall. After absorption aspirin is rapidly converted to salicylate but during the first 20 minutes aspirin is the predominant form of the drug in the plasma. Aspirin is bound to plasma proteins and is widely distributed. Plasma-aspirin concentrations decline rapidly (half-life 15-20 minutes) as plasma salicylate concentrations increase. Both aspirin and salicylate have pharmacological activity; only aspirin has an anti-platelet effect. Salicylate is mainly eliminated by hepatic metabolism; the metabolites include salicyluric acid, salicyl phenolic glucuronide, salicylic acyl glucuronide, gentisic acid, and gentisuric acid. Salicylate is also excreted unchanged in the urine; the amount excreted by this route increases with increasing dose and also depends on urinary pH, about 30% of a dose being excreted in alkaline urine compared with 2% of a dose in acidic urine. Renal excretion involves glomerular filtration, active renal tubular secretion, and passive tubular reabsorption. Salicylates appear in breast milk and cross the placenta.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Also contains: citric acid, lactose, maize starch, saccharin sodium, E170.
6.2 Incompatibilities
Iron salts, alkalis and carbonates.
6.3 Shelf life
Shelf-life
Tablet container: 2 years Blister pack: 1 year
Shelf-life after dilution/reconstitution Not applicable.
Shelf-life after first opening Not applicable.
6.4 Special precautions for storage
Store below 25 °C in a dry place.
Keep tightly closed.
6.5 Nature and contents of container
Child-resistant blister pack: (i) white 250pm PVC/30pm PE/90g/m2 PVdC (ii) 9pm soft aluminium / 35g/m2 glassine paper. Compliant with BS EN 14375.
Pack sizes:
P: 28, 30, 56, 60, 100.
PE tablet container with a child-resistant PP closure. A 2g silica gel container is included in each pack. Compliant with ISO 8317.
Pack sizes:
P: 100.
POM: 1000.
PP tablet container with a PE closure for dispensing purposes or supply to nursing homes. A 2g silica gel container is included in each pack.
Pack size:
POM: 1000.
Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. An appropriate number of 2g silica gel containers are included in each pack.
Maximum size of bulk packs: 10,000.
6.6 Special precautions for disposal
Not applicable.
7
MARKETING AUTHORISATION HOLDER
Actavis UK Limited (Trading style: Actavis) Whiddon Valley BARNSTAPLE N Devon EX32 8NS
8 MARKETING AUTHORISATION NUMBER(S)
PL 00142/0377
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
8th February 1994 Renewed: June 1999
10 DATE OF REVISION OF THE TEXT
22/10/2010