Racecadotril Substipharm 10 mg Granulat till oral suspension

País: Suécia

Língua: sueco

Origem: Läkemedelsverket (Medical Products Agency)

Ingredientes ativos:

racekadotril

Disponível em:

Substipharm

Código ATC:

A07XA04

DCI (Denominação Comum Internacional):

racekadotril

Dosagem:

10 mg

Forma farmacêutica:

Granulat till oral suspension

Composição:

sackaros Hjälpämne; racekadotril 10 mg Aktiv substans

Tipo de prescrição:

Receptbelagt

Status de autorização:

Avregistrerad

Data de autorização:

2019-10-25

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Racecadotril Substipharm 10 mg Granules for Oral Suspension
Racecadotril Substipharm 30 mg Granules for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg sachet contains 10 mg of racecadotril and 979.8 mg of
sucrose
Each 30 mg sachet contains 30 mg of racecadotril and 2.9 g of sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to off white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Racecadotril Substipharm is administered via the oral route, together
with oral rehydration (see section
4.4). 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.
Racecadotril Substipharm 10 mg:
Racecadotril Substipharm 10 mg is intended for children ≤ 13 kg.
Infants weighing up to 9kg: one 10 mg dose sachet 3 times a day
Infants weighing from 9kg to 13kg: two 10 mg dose sachet 3 times a day
Racecadotril Substipharm 30 mg:
Children weighing from 13 kg to 27 kg: one 30 mg sachet 3 times daily.
Children weighing 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 Section 4.4).
Caution is advised in patien