DISPRIN 300MG DISPERSIBLE TABLETS
Active substance: ASPIRIN
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Disprin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient Aspirin mg/Tablet 300.00 Specification Ph Eur
3
PHARMACEUTICAL FORM
Dispersible tablet
4
4.1
CLINICAL PARTICULARS
Therapeutic indications
For the relief of mild to moderate pain in headaches, including migraine headaches, toothache, neuralgia, sciatica, period pains and sore throats. Reduction of temperature in feverishness, influenza and colds. Reduction of inflammation in rheumatism and lumbago.
4.2
Posology and method of administration
Oral administration after dissolution in water. Adults (including children 16 years and over): Two to three tablets every 4 hours. Do not exceed 13 tablets in 24 hours. Do not give to children aged under 16 years unless specifically indicated (e.g. for Kawasakis disease).
There is no indication that dosage need be modified in the elderly.
4.3
Contraindications
Should not be given to patients suffering from a previous history of peptic ulceration or active peptic ulceration or haemophilia.
4.4
Special warnings and precautions for use
The product labelling will include: Do not give to children under 16 years unless on the advice of a doctor. Keep out of reach of children. If you are receiving regular medical treatment, are asthmatic, allergic to aspirin or have or have had a stomach ulcer, seek your doctors advice before taking this product. There is a possible association between aspirin and Reyes Syndrome when given to children. Reyes 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 Kawasakis disease).
4.5
Interaction with other medicinal products and other forms of interaction Aspirin may enhance the effects of anticoagulants and inhibit the effects of uricosurics. 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
There is clinical and epidemiological evidence of the safety of aspirin in human pregnancy, but it may prolong labour and contribute to maternal and neonatal bleeding and is best avoided at term and during breastfeeding.
4.7
Effects on ability to drive and use machines
None known.
4.8
Undesirable effects
May precipitate bronchospasm and induce attacks of asthma or hypersensitivity in susceptible subjects. May also induce gastrointestinal 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 (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning. Symptoms Common features 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 four years. In children aged four 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, thrombocytopaenia, 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 ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Aspirin: Aspirin inhibits the cyclo-oxygenase enzyme involved in conversion of phospholipids to prostaglandins and its effects on the body are believed to result primarily from prevention of prostaglandin production. These effects include peripheral analgesia, fever reduction, reduction in inflammation and inhibition of platelet aggregation. 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 dosing (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 like for occasional ibuprofen use.
5.2
Pharmacokinetic properties
Aspirin is rapidly absorbed from the stomach and upper gastrointestinal tract with peak levels after around 20-30 minutes following dissolution. It is subject to first-pass metabolism with an overall bioavailability of around 70%. Metabolism is by conversion to salicylic acid and then by further conversion to other metabolites. These are excreted by the kidneys in both free and conjugated form. The plasma halflife of aspirin is around 15-20 minutes and that of salicylic acid is 2-3 hours.
5.3
Preclinical safety data
No preclinical findings of relevance have been reported.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients
Calcium carbonate, maize starch, citric acid, talc, sodium lauryl sulphate, saccharin, crospovidone and lime flavour.
6.2
Incompatibilities
None known.
6.3
Shelf life
Three years.
6.4
Special precautions for storage
Store below 25C in a dry place.
6.5
Nature and contents of container
Cardboard carton containing tablets in strips of aluminium foil with vinyl heat seal. Pack sizes: 6, 8, 12, 16, 24, 32, 48, 96 and 500 tablets. (Those pack sizes printed in bold are currently sold).
6.6
Special precautions for disposal
Oral administration after dissolution in water.
7
MARKETING AUTHORISATION HOLDER
Reckitt Benekiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS United Kingdom.
8
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0017.
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/04/1995 / 23/02/2004
10
DATE OF REVISION OF THE TEXT
26/01/2009
1
NAME OF THE MEDICINAL PRODUCT
Disprin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient Aspirin mg/Tablet 300.00 Specification Ph Eur
3
PHARMACEUTICAL FORM
Dispersible tablet
4
4.1
CLINICAL PARTICULARS
Therapeutic indications
For the relief of mild to moderate pain in headaches, including migraine headaches, toothache, neuralgia, sciatica, period pains and sore throats. Reduction of temperature in feverishness, influenza and colds. Reduction of inflammation in rheumatism and lumbago.
4.2
Posology and method of administration
Oral administration after dissolution in water. Adults (including children 16 years and over): Two to three tablets every 4 hours. Do not exceed 13 tablets in 24 hours. Do not give to children aged under 16 years unless specifically indicated (e.g. for Kawasakis disease).
There is no indication that dosage need be modified in the elderly.
4.3
Contraindications
Should not be given to patients suffering from a previous history of peptic ulceration or active peptic ulceration or haemophilia.
4.4
Special warnings and precautions for use
The product labelling will include: Do not give to children under 16 years unless on the advice of a doctor. Keep out of reach of children. If you are receiving regular medical treatment, are asthmatic, allergic to aspirin or have or have had a stomach ulcer, seek your doctors advice before taking this product. There is a possible association between aspirin and Reyes Syndrome when given to children. Reyes 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 Kawasakis disease).
4.5
Interaction with other medicinal products and other forms of interaction Aspirin may enhance the effects of anticoagulants and inhibit the effects of uricosurics. 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
There is clinical and epidemiological evidence of the safety of aspirin in human pregnancy, but it may prolong labour and contribute to maternal and neonatal bleeding and is best avoided at term and during breastfeeding.
4.7
Effects on ability to drive and use machines
None known.
4.8
Undesirable effects
May precipitate bronchospasm and induce attacks of asthma or hypersensitivity in susceptible subjects. May also induce gastrointestinal 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 (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning. Symptoms Common features 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 four years. In children aged four 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, thrombocytopaenia, 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 ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Aspirin: Aspirin inhibits the cyclo-oxygenase enzyme involved in conversion of phospholipids to prostaglandins and its effects on the body are believed to result primarily from prevention of prostaglandin production. These effects include peripheral analgesia, fever reduction, reduction in inflammation and inhibition of platelet aggregation. 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 dosing (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 like for occasional ibuprofen use.
5.2
Pharmacokinetic properties
Aspirin is rapidly absorbed from the stomach and upper gastrointestinal tract with peak levels after around 20-30 minutes following dissolution. It is subject to first-pass metabolism with an overall bioavailability of around 70%. Metabolism is by conversion to salicylic acid and then by further conversion to other metabolites. These are excreted by the kidneys in both free and conjugated form. The plasma halflife of aspirin is around 15-20 minutes and that of salicylic acid is 2-3 hours.
5.3
Preclinical safety data
No preclinical findings of relevance have been reported.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients
Calcium carbonate, maize starch, citric acid, talc, sodium lauryl sulphate, saccharin, crospovidone and lime flavour.
6.2
Incompatibilities
None known.
6.3
Shelf life
Three years.
6.4
Special precautions for storage
Store below 25C in a dry place.
6.5
Nature and contents of container
Cardboard carton containing tablets in strips of aluminium foil with vinyl heat seal. Pack sizes: 6, 8, 12, 16, 24, 32, 48, 96 and 500 tablets. (Those pack sizes printed in bold are currently sold).
6.6
Special precautions for disposal
Oral administration after dissolution in water.
7
MARKETING AUTHORISATION HOLDER
Reckitt Benekiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS United Kingdom.
8
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0017.
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/04/1995 / 23/02/2004
10
DATE OF REVISION OF THE TEXT
26/01/2009
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
