MACROSOFT 10 Grams Powder for Oral Solution

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

MACROGOL 4000

Tilgængelig fra:

PharOS - Pharmaceutical Oriented Services Ltd

ATC-kode:

A06AD15

INN (International Name):

MACROGOL 4000

Dosering:

10 Grams

Lægemiddelform:

Powder for Oral Solution

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Osmotically acting laxatives

Autorisation status:

Authorised

Autorisation dato:

2015-01-30

Indlægsseddel

 
7 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

 10 G POWDER FOR ORAL SOLUTION IN SACHET 
MACROGOL 4000 

is and what it is used for 
2. 
What you need to know before you take  
3. 
How to take  
4. 
Possible side effects 
5.  
How to store  
6. 
Contents of the pack and other information 

1. 
WHAT  IS AND WHAT IT IS USED FOR 

belongs to a group of medicines called
osmotic laxatives.  It works by 
carrying water to your s

Produktets egenskaber

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