Smecta 3g powder for oral suspension with orange flavour

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

diosmectite

Available from:

Beaufour Ipsen Industrie

ATC code:

A07BC05

INN (International Name):

diosmectite

Dosage:

3g

Pharmaceutical form:

powder for oral suspension with orange flavour

Units in package:

(10) sachets 3,76g, (30) sachets 3,76g

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2015-02-20

Summary of Product characteristics

_CIS 6 956 407 3 _
1
_MOOO/1000/003 _
APPENDIX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SMECTA 3 G ORANGE-VANILLA, POWDER FOR ORAL SUSPENSION IN SACHET
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diosmectite
………………………………………………………………………..3.000
g
For one sachet of 3.760 g.
Excipients with a known effect: glucose, sucrose.
A full list of excipients is given in section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension
.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of acute diarrhoea in children and infants, in addition to
oral rehydration and in adults.
Symptomatic treatment of chronic functional diarrhoea in adults.
Symptomatic treatment of pain associated with functional bowel
diseases in adults.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Treatment of acute diarrhoea:
In infants and children:
•
Up to 1 year: 2 sachets per day for 3 days, then 1 sachet per day.
•
1 year and older: 4 sachets per day for 3 days, then 2 sachets per
day.
In adults: on average, 3 sachets per day. In practice the daily dose
can be doubled at the start of
treatment.
Other indications:
In adults: on average of 9 grams (3 sachets) per day.
METHOD OF ADMINISTRATION
Oral route
The contents of the sachet must be mixed in suspension, just before
use.
In infants and children, the contents of the sachet can be mixed in a
feeding bottle of 50 ml of water to be
given at intervals during the day, or mixed with semi-liquid food,
such as broth, compote, puree, baby
food...
In adults, the contents of the sachet can be mixed into half a glass
of water.
4.3.
CONTRAINDICATIONS
Hypersensitivity to diosmectite or to any of the excipients listed in
section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_CIS 6 956 407 3 _
2
_MOOO/1000/003 _
Diosmectite must be used with caution in patients with a history of
severe chronic constipation.
In children, acute diarrhoea must be treated in conjunction with early
administration of an oral
rehydrat