ductive and developmental toxicity (fertility and early embryonic development, prenatal and postnatal development including maternal function, embryo-foetal development studies) have not revealed any special effects of racecadotril.
A toxicity study in juvenile rats has not revealed any significant effects of racecadotril up to a dose of 160mg/kg/day which is 35 times higher than the usual paediatric regimen (i.e. 4.5mg/kg/day). Despite the immature renal function in children below 1 year of age, higher exposure levels are not expected in these individuals
Other preclinical effects (e.g., severe, most likely aplastic anaemia, increased diuresis, ketonuria,diarrhoea,) were observed only at exposures considered sufficiently in excess of maximum human exposure. Their clinical relevance is unknown.
Other safety pharmacology studies did not evidence any deleterious effects of racecadotril on the central nervous system, the cardiovascular and the respiratory functions.
In animals, racecadotril reinforced the effects of butylhyoscine upon bowel transit and on the anticonvulsive effects of phenytoin.
6. Pharmaceutical particulars
6.1 List of excipients
Sucrose,
Anhydrous colloidal silica,
polyacrylate dispersion 30 per cent,
Apricot aroma.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Thermowelded paper/aluminium/polyethylene sachets
Packs containing 10, 16, 20, 30, 50 and 100 sachets (100 sachets only for hospital use)
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Bioprojet Europe Ltd.
29 Earlsfort Terrace
EI-Dublin 2
IRELAND
8. Marketing authorisation number(s)
PL 39418/0002
9. Date of first authorisation/renewal of the authorisation
02/09/2011
10. Date of revision of the text
16/07/2015
