Hidrasec Infants Granules for Oral Suspension 10mg

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

Therapeutic

Prescription Only

GRANULE, FOR SUSPENSION

**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.