DISPRIN Dispersible tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Disprin.
2. Qualitative and quantitative composition
Active Ingredient mg/Tablet Specification Aspirin 300.00 Ph Eur <u>Excipient(s) with known effect:</u> Sodium 0.12 mg (0.005 mmol) per tablet, Soy protein 0.0625–0.125 mg per tablet For the full list ...
3. Pharmaceutical form
Dispersible tablet.
4.1. 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 ...
4.2. Posology and method of administration
Oral administration after dissolution in water. <u>Adults (including children 16 years and over):</u> Two to three tablets every 4 hours. Do not exceed 13 tablets in 24 hours. Do not give to children aged ...
4.3. Contraindications
Should not be given to patients suffering from a previous history of peptic ulceration or active peptic ulceration or haemophilia. Dispirin contains soy protein. If you are allergic to peanut or soya do ...
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, ...
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 ...
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 ...
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. Reporting of suspected adverse reactions ...
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 ...
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 ...
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 ...
5.3. Preclinical safety data
No preclinical findings of relevance have been reported.
6.1. List of excipients
Calcium carbonate Maize starch Citric acid Talc Sodium lauryl sulphate Saccharin Crospovidone Lime flavour
6.2. Incompatibilities
None known.
6.3. Shelf life
Three years.
6.4. Special precautions for storage
Store below 25°C in a dry place.
6.5. Nature and contents of container
Cardboard carton containing tablets in strips of aluminium foil with vinyl heat seal. <u>Pack sizes:</u> 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 and other handling
Oral administration after dissolution in water.
7. Marketing authorization holder
Reckitt Benekiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
8. Marketing authorization number(s)
PL 00063/0017
9. Date of first authorization / renewal of the authorization
24/04/1995 / 23/02/2004
10. Date of revision of the text
30/11/2020
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