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DISPRIN DIRECT

Active substance(s): ASPIRIN / ASPIRIN / ASPIRIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Disprin Direct

2

3

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient

mg/Tablet

Specification

Aspirin

300

Ph Eur

PHARMACEUTICAL FORM
Dispersible tablet.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of mild to moderate pain in headaches including tension headaches,
migraine headaches, toothache, neuralgia, period pains, rheumatic pain, lumbago and
sciatica. To relieve the symptoms of influenza, feverishness, feverish colds and ease
sore throats.

4.2

Posology and method of administration
Disprin Direct disperses on the tongue without water.
Adults and children 16 years and over: One to three tablets to a maximum of 13
tablets in 24 hours. The dose may be repeated after 4 hours, but the maximum dose in
24 hours must not be exceeded.

Elderly: There is no indication that dosage need be modified in the elderly.
Do not give to children aged under 16 years unless specifically indicated (e.g. for
Kawasaki’s disease).

4.3

Contraindications
Should not be given to patients suffering from active peptic ulceration or
haemophilia.

4.4

Special warnings and precautions for use
If you are receiving medical treatment, are asthmatic, allergic to aspirin or have or
have had a stomach ulcer, seek your doctor’s advice before taking this product.
The product labelling will include “Do not give to children aged under 16 years
unless on the advice of a 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 aspirin should not be given to children aged under 16
years unless specifically indicated (e.g. for Kawasaki’s 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 stated.

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

PHARMACOLOGICAL PROPERTIES

5.1

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 half
life 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

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Glycine
Maize starch
Microcrystalline cellulose
Purified talc
Saccharin
Lemon flavour 51124

6.2

Incompatibilities
None stated

6.3

Shelf life
Three years.

6.4

Special precautions for storage
Store below 35°C.

6.5

Nature and contents of container
Vinyl coated heat sealed foils (4, 6, 8, 16, 24 and 48 tablet packs). (Only the packs
printed in bold are currently marketed).

6.6

Special precautions for disposal
Disprin Direct disperses on the tongue without water.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0018.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/04/1995 / 20/05/2005

10

DATE OF REVISION OF THE TEXT
25/02/2015

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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