Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Bioprojet Europe Ltd., 29 Earlsfort Terrace, EI-Dublin 2, IRELAND
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.
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.
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.
No cases of overdose have been reported. In adults, single doses above 2 g, which is equivalent to 20 times the therapeutic dose, have been administered, and no harmful effects have been described.
2 years.
This medicinal product does not require any special storage conditions.
Thermowelded paper/aluminium/polyethylene sachets.
Packs containing 10, 16, 20, 30, 50 and 100 sachets (100 sachets only for hospital use).
Not all pack sizes may be marketed.
No special requirements.
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