HIDRASEC CHILDREN

4). Hidrasec 30 mg is intended for children ≥13 kg. 5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily at regular intervals. In children from 13 kg to 27 kg : one 30 mg sachet 3 times daily. In children of more than 27 kg : two 30 mg sachets 3 times daily.

The duration of treatment in the clinical trials with children was 5 days. Treatment should be continued until two normal stools are recorded. Treatment should not exceed 7 days. Paediatric population There are no clinical trials to support treatment in infants less than 3 months old.

4). Method of administration The granules can be added to food, dispersed in a glass of water or in the feeding-bottle, mixing well and followed by immediate administration.

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).

Infections and infestations: - Uncommon: tonsillitis. Skin and subcutaneous tissue disorders: - Uncommon: rash, erythema. - Unknown: erythema multiforme, tongue oedema, face oedema, lip oedema, eyelid oedema, angioedema, urticaria, erythema nodosum, rash papular, prurigo, pruritus.

Reporting of suspected adverse reactions 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. uk/yellowcard

Rehydration (including vomiting and diarrhoea) 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. Hypersensitivity 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.

Angioedema Angioedema of the face, extremities, lips, mucous membranes may occur during racecadotril treatment. This angioedema can be allergic (mast cell mediator-induced angioedema), or non-allergic (bradykinin-mediated angioedema).

5). 5). If upper airway obstruction, emergency therapy should be administered whatever the aetiology of angioedema, as the outcome of this condition can be fatal. If angioedema occurs, racecadotril should be discontinued, and the patient should be under close medical supervision until complete and sustained resolution of symptoms.

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.