Idrolax 10g, powder for oral solution in a sachet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Macrogol 4000

Available from:

Ipsen Pharma

ATC code:

A06AD; A06AD15

INN (International Name):

Macrogol 4000

Dosage:

10 gram(s)

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives; macrogol

Authorization status:

Not marketed

Authorization date:

2002-02-22

Summary of Product characteristics

Health Products Regulatory Authority
01 May 2019
CRN008MPX
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Idrolax 10g, powder for oral solution in a sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 10g of macrogol 4000.
Excipients:
Flavour
(orange-grapefruit)*..............................................................
0.15 g
Saccharin
sodium................................................................................
0.017 g
Per sachet of 10.17 g
*Sorbitol and sulphur dioxide are constituents of orange-grapefruit
flavour:
Sorbitol (E420)
………………………………………………………1.8 mg
per sachet.
Sulphur dioxide (E220)
……………………………………………….0.24* x 10
-2
mg per sachet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution in sachet.
Almost white powder with an odour and taste of orange-grapefruit.
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. IDROLAX 10 g should remain a temporary
adjuvant treatment to appropriate lifestyle and dietary management of
constipation, with a maximum 3-month 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
Oral use.
Posology
1 to 2 sachets (10-20 g) per day, preferably taken as a single dose in
the morning.
The daily dose should be adjusted according to the clinical response
and may range from one sachet every other day
(especially in children) up to 2 sachets a day.
The effect of IDROLAX becomes apparent within 24 to 48 hours after its
administration.
Paediatric population
In children, treatment should not exceed 3 months due to a lack of
clinical data for treatment lasting longer than 3 months.
Treatment-induced restoration of bowel mo