HIDRASEC

For oral use.

For Adults only:

One capsule initially regardless of the time of day. Then, one capsule three times daily preferably before the main meals. Treatment should be continued until two normal stools are recorded. Treatment should not exceed 7 days.

Special populations:

Paediatric population: There are specific formulations intended for infants and children. 2). Caution is advised in patients with hepatic or renal impairment.

Data from clinical acute diarrhoea studies are available for 2193 adult patients treated with racecadotril and 282 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).

Nervous system disorders Common: headache. 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, toxic skin eruption.

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 racecadotril does not modify the usual rehydration regimens. 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. There is a possible reduced availability in patients with prolonged vomiting. Chronic diarrhoea has not been sufficiently studied with this medicinal 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.

Racecadotril should not be reintroduced. Renal or hepatic impairment There are limited data in patients with renal or hepatic impairment. 2). Excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, The Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1.