Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Bioprojet Europe Ltd., 29 Earlsfort Terrace, EI-Dublin 2, IRELAND
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or saccharase-isomaltase deficiency should not take this medicine.
The administration of Hidrasec does not modify the usual rehydration regimens.
Rehydration is highly important in the management of acute diarrhoea in infants.
The requirement for rehydration and route should be adapted to the age and weight of the patient and the stage and severity of the condition, specifically in case of serious or prolonged diarrhoea with significant vomiting or a lack of appetite.
In the event of serious or prolonged diarrhoea with important vomiting or a lack of appetite, intravenous rehydration should be considered.
The presence of bloody or purulent stools and fever may indicate the presence of invasive bacteria as a reason for diarrhoea, or the presence of other severe disease. Also, racecadotril has not been tested in antibiotic-associated diarrhoea. Therefore, racecadotril should not be administered under these conditions.
Chronic diarrhoea has not been sufficiently studied with this product.
In patients with diabetes, it should be taken into account that each sachet contains 0.966 g of sucrose.
If the quantity of sucrose (source of glucose and fructose) present in the daily dose of Hidrasec 10 mg exceeds 5 g a day, the latter should be taken into account in the daily sugar ration.
The product must not be administered to infants less than 3 months old, as there are no clinical trials in this population.
The product must not be administered to children with renal or liver impairment, whatever the degree of severity, due to a lack of information on these patient populations.
Because of possible reduced bioavailability, the product must not be administered in cases of prolonged or uncontrolled vomiting.
Occurrence of skin reactions has been reported with the use of the product. These are in most cases mild and do not require treatment but in some cases they can be severe, even life-threatening. Association with racecadotril cannot be fully excluded. When experiencing severe skin reactions, the treatment has to be stopped immediately.
No interactions with other active substances have been described in humans to date.
In humans, joint treatment with racecadotril and loperamide or nifuroxazide does not modify the kinetics of racecadotril.
Fertility studies conducted with racecadotril on Rats demonstrate no impact on fertility.
There are no adequate data from the use of racecadotril in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, fertility, embryo- foetal development, childbirth/delivery or postnatal development. However, since no specific clinical studies are available, racecadotril should not be administered to pregnant women.
Due to the lack of information regarding racecadotril excretion in human milk, this medicinal product should not be administered to breastfeeding women.
Not relevant.
Racecadotril has no or negligible influence on the ability to drive and use machines.
Data from clinical acute diarrhoea studies are available for 860 paediatric patients treated with racecadotril, and 441 treated with placebo.
The following adverse drug reactions listed below have occurred with racecadotril more often than with placebo or have been reported during post-marketing surveillance. The frequency of adverse reactions is defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Uncommon: tonsillitis.
Uncommon: rash, erythema.
Unknown: erythema multiforme, tongue oedema, face oedema, lip oedema, eyelid oedema, angioedema, urticaria, erythema nodosum, rash papular, prurigo, pruritus.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
Not applicable.
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