Macrosoft 10 g Powder for Oral Solution in Sachet

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Macrogol 4000

Beschikbaar vanaf:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC-code:

A06AD; A06AD15

INN (Algemene Internationale Benaming):

Macrogol 4000

Dosering:

10 gram(s)

farmaceutische vorm:

Powder for oral solution

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Osmotically acting laxatives; macrogol

Autorisatie-status:

Not marketed

Autorisatie datum:

2015-01-30

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Macrosoft 10 g Powder for Oral Solution in Sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 10 g macrogol 4000.
Excipient with known effect:
Each sachet contains 0.2 mg sorbitol (contained in lemon-grapefruit
flavour).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution in sachet.
White powder, free of large agglomerates, with an odour and taste of
lemon, packed in a sachet for the preparation of
an oral solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of constipation in adults and children aged 8
years and above.
An organic disorder should have been ruled out before initiation of
treatment with Macrosoft. Macrosoft should remain
a temporary adjuvant treatment to appropriate lifestyle and dietary
management of constipation, with a maximum 3-
months treatment course in children. If symptoms persist despite
associated dietary measures, an underlying cause
should be suspected and treated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
It is generally recommended to consider healthy lifestyle measures
such as adequate hydration, physical activity, and
increased natural fibre intake. In case the symptoms persist or get
worse, a physician should be consulted.
_Adults_
1 to 2 sachets (10 to 20 g macrogol 4000) per day, preferably taken as
a single dose in the morning.
_Paediatric population_
~_ CHILDREN_
_8 YEARS AND ADOLESCENTS:_ 1 to 2 sachets (10 to 20 g macrogol 4000)
per day, preferably taken as a single
dose in the morning.
~_ CHILDREN (<8 YEARS):_
Macrosoft is not recommended for use in children below the age of 8
years.
The daily dose should be adapted as required to produce regular soft
stools and may range from one sachet every other
day (especially in children) up to 2 sachets a day. If administered
regularly, the frequency of bowel movements tends to
be one movement per day. In children, treatment should not exceed 3
months due to a lack o