Hidrasec

国: アルメニア

言語: 英語

ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有効成分:

racecadotril

から入手可能:

Sophartex

INN（国際名）:

racecadotril

投薬量:

100mg

医薬品形態:

capsules

処方タイプ:

Prescription

製品の特徴

Page 1 of 5
SUMMARY OF THE PRODUCT CHARACTERISTICS
RACECADOTRIL, CAPSULES
1. NAME OF THE MEDICINAL PRODUCT
Hidrasec, 100 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hidrasec 100mg:
Each capsule contains 100 mg of racecadotril.
Excipients: Each capsule contains 41 mg lactose
3. PHARMACEUTICAL FORM
Hidrasec 100mg:
Hard capsule.
Ivory coloured capsules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hidrasec 100mg:
Hidrasec is indicated in the symptomatic treatment of acute diarrhoea
in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Hidrasec 100mg:
For oral use.
Adults: One capsule initially regardless of the time of day. Then, one
capsule three times daily
preferably before the main meals. Treatment should not exceed 7 days.
Special populations:
Children: There are specific formulations intended for infants,
children and adolescents.
Elderly: Dosage adjustment is not necessary in the elderly.
4.3 CONTRAINDICATIONS
Hidrasec 100mg:
Hypersensitivity to the active substance or to any of the excipients.
Breastfeeding.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hidrasec 100mg:
Precautions for use :
The administration of Hidrasec does not modify the usual rehydration
regimens.
The presence of bloody or purulent stools and fever may indicate the
presence of invasive bacteria as a
reason for diarrhoea, or the presence of other severe disease.
Therefore, racecadotril should not be
administered under these conditions.
Chronic diarrhoea has not been sufficiently studied with this
medicinal product. Also, racecadotril has
not been tested in antibiotic associated diarrhoea.
There are limited data in patients with renal or hepatic impairment.
These patients should be treated
with caution (see section 5.2).
Page 2 of 5
SUMMARY OF THE PRODUCT CHARACTERISTICS
RACECADOTRIL, CAPSULES
There is a possible reduced availability in patients with prolonged
vomiting.
Warning :
This
medicinal
product
contains
lactose.
Patients
with
rare
hereditary
problems
of
galactose
intolerance, the Lapp lactase deficiency or glu