Hidrasec Infants Granules for Oral Suspension 10mg

4.1 Therapeutic indications

Hidrasec Infants 10mg, Hidrasec Children 30mg:

Complementary, symptomatic treatment of acute diarrhoea in infants (older than 3 months) and children, when oral rehydration and usual support measures are insufficient to control the clinical condition.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients.

• Patients who have reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril) should not take racecadotril.

Due to the presence of sucrose, Hidrasec Infants/Children is contraindicated in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency.

4.2 Posology and method of administration

Hidrasec Infants 10mg and Hidrasec Children 30mg are administered via the oral route, together with oral rehydration (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hidrasec Infants 10mg is intended for children < 13kg.

Hidrasec Children 30mg is intended for children ≥ 13kg.

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 infants less than 9 kg: one 10 mg sachet 3 times daily.

In infants from 9 kg to < 13 kg: two 10 mg sachets 3 times daily.

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. Long term treatment with racecadotril is not recommended.

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

Special populations:

There are no studies in infants or children with renal impairment or hepatic impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.