1. Name of the medicinal product
Hidrasec 10 mg, Granules for oral suspension.

2. Qualitative and quantitative composition
Each sachet contains 10 mg of racecadotril.

Each sachet contains 966.5 mg of sucrose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical form
Granules for oral suspension.

White powder with characteristic apricot smell.

4. Clinical particulars
4.1 Therapeutic indications
Complementary symptomatic treatment of acute diarrhoea in infants (older than 3 months) and in children together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition, and when causal treatment is not possible.

If causal treatment is possible, racecadotril can be administered as a complementary treatment.

4.2 Posology and method of administration
Hidrasec 10 mg is administered via the oral route, together with oral rehydration (see section 4.4).

Hidrasec Infants is intended for children <13 kg

The recommended dose is determined according to body weight: 1.5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily at regular intervals.

In infant less than 9 kg  : one 10 mg sachet 3 times daily.
 
In infant from 9 kg to 13 kg  : two 10 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.

There are no clinical trials in infants fewer than 3 months of age.

Special populations:

There are no studies in infants or children with renal impairment or hepatic impairment (see section 4.4).

Caution is advised in patients with hepatic or renal impairment.

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.

4.3 Contraindications
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.

4.4 Special warnings and precautions for use
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.

Warnings

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 an