Hidrasec

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

racecadotril

Available from:

Sophartex

INN (International Name):

racecadotril

Dosage:

30mg

Pharmaceutical form:

granules for oral suspension

Prescription type:

Prescription

Summary of Product characteristics

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SUMMARY OF THE PRODUCT CHARACTERISTICS
RACECADOTRIL, GRANULES FOR ORAL SUSPENSION
1. NAME OF THE MEDICINAL PRODUCT
Hidrasec 10 mg or 30 mg granules for oral suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Hidrasec contains 10 mg or 30 mg of racecadotril
For excipients, see section 6.1
3. PHARMACEUTICAL FORM
Granules for oral suspension.
White powder with characteristic apricot smell.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Complementary symptomatic treatment of acute diarrhoea in infants
(older than 3 months) and in
children when oral rehydration and the usual support measures are
insufficient to control the clinical
condition.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Hidrasec 10mg, Hidrasec 30mg are 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 administration, with an
initial administration followed by 3 administrations in the course of
the day. Treatment duration should
not exceed 7 days.
There are no monitored 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).
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.
Due to the presence of saccharose,
Hidrasec
30mg is contraindicated in patients with fructose
intolerance, glucose malabsorption syndrome and saccharase-isomaltase
deficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The administration of Hidrasec does not modify the usual rehydration
regimens. It is essential for the
children to drink abundant liquid.
In the
event of serious or prolonged diarrhoea with important vomiting or a
lack of appetite,
intravenous rehydration should be considered.
The presence of bloody or purulent stools and fe