Capsule: Oral route.
Adults: In the treatment of acute diarrhoea, the treatment should be initiated with a single 100 mg capsule given regardless of the time, further treatment is a single 100 mg capsule at the beginning of the three main meals.
The administration of Hidrasec 100 mg capsules does not exempt of rehydration therapy if necessary. The duration of treatment must not exceed seven days.
Specific populations: Paediatric population: Hidrasec 100 mg capsules must not be administered to infants and children.
Other pharmaceutical forms of Hidrasec suitable for the paediatric population are available.
Elderly: Dosage adjustment is not necessary in the elderly (see Pharmacology: Pharmacokinetics under Actions).
Caution is advised in patients with hepatic or renal impairment.
Granules for oral suspension: Hidrasec Infants 10 mg and Hidrasec Children 30 mg are administered via the oral route, together with oral rehydration (see Precautions).
Hidrasec Infants 10 mg is intended for children <13 kg. Hidrasec Children 30 mg 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.
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.
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 Warnings).
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.
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