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HIDRASEC INFANTS GRANULES FOR ORAL SUSPENSION 10MG [SIN14412P]
Active ingredients: HIDRASEC INFANTS GRANULES FOR ORAL SUSPENSION 10MG
Last updated 26 October 2025
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Product Info
HIDRASEC INFANTS GRANULES FOR ORAL SUSPENSION 10MG
[SIN14412P]
Product information
Active Ingredient and Strength | RACECADOTRIL - 10 MG |
Dosage Form | GRANULE, FOR SUSPENSION |
Manufacturer and Country | LABORATOIRES SOPHARTEX - FRANCE |
Registration Number | SIN14412P |
Licence Holder | ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A07XA04 |
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.
4.2 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.
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.