Hidrasec Infants Granules for Oral Suspension 10mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Racecadotril

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC code:

A07XA04

Dosage:

10.00mg

Pharmaceutical form:

GRANULE, FOR SUSPENSION

Composition:

Racecadotril 10.00mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Laboratoires Sophartex

Authorization status:

ACTIVE

Authorization date:

2013-09-30

Patient Information leaflet

 
Updated 25 Sep 2014 

Page 1 of 6 

1. 
NAME OF THE MEDICINAL PRODUCT 

Hidrasec Infants Granules for Oral Suspension 10 mg 
Hidrasec Children Granules for Oral Suspension 30 mg 

2. QUALITATIVE 
AND 
QUANTITATIVE 
COMPOSITION 

Each sachet of Hidrasec Infants contains 10 mg of
racecadotril. 
Each sachet of Hidrasec Children contains
30 mg of racecadotril. 

Excipients with known effect 
Each sachet Hidrasec Infants contains 0.966 g of sucrose. 
Each sachet Hidrasec Children contains 2.9 g of sucrose. 

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL 
FORM 

Granules for oral suspension. 
White powder with apricot smell.

4. CLINICAL 
PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 
Hidrasec Infants10mg, 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). 

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. 

Updated 25 Sep 2014 

Page 2 of 6 
The duration of treatment in the clinical trials with children was
5 days. Treatment should be 
continued until two normal s

Summary of Product characteristics

Updated 17 August 2017
Page 1 of 7
1.
NAME OF THE MEDICINAL PRODUCT
Hidrasec Infants Granules for Oral Suspension 10 mg
Hidrasec Children Granules for Oral Suspension 30 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Hidrasec Infants contains 10 mg of racecadotril.
Each sachet of Hidrasec Children contains 30 mg of racecadotril.
Excipients with known effect
Each sachet Hidrasec Infants contains 0.966 g of sucrose.
Each sachet Hidrasec Children contains 2.9 g of sucrose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Granules for oral suspension.
White powder with apricot smell.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hidrasec Infants10mg, 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).
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.
Updated 17 August 2017
Page 2 of 7
_Special populations_
:
There are no studies in infants or children with renal impair