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 Consumer HealthCare

ATC code:

A06AD; A06AD15

INN (International Name):

Macrogol 4000

Dosage:

10 gram(s)

Pharmaceutical form:

Powder for oral solution in sachet

Therapeutic area:

Osmotically acting laxatives; macrogol

Authorization status:

Not marketed

Authorization date:

2002-02-22

Patient Information leaflet

__________________________________________________________________________________________________________
Document name: 23_IDR_IE
Reason for change: Type IB Variation to update the product information
according to CCDS V2.0
Document replaced: 20.1_IDR_IE
Preparation date: 17/01/2022
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IDROLAX 10 G, POWDER FOR ORAL SOLUTION IN SACHET
Macrogol 4000
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

You must consult your doctor if your symptoms worsen or do not
improve.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Idrolax is and what it is used for
2.
What you need to know before you take Idrolax
3.
How to take Idrolax
4.
Possible side effects
5.
How to store Idrolax
6.
Contents of the pack and other information
1.
WHAT IDROLAX IS AND WHAT IT IS USED FOR
Idrolax contains the active substance Macrogol 4000 and belongs to a
group of medicines called osmotic
laxatives. It works by adding water to
the stools, which helps to overcome problems caused by very slow
bowel movements. Idrolax is not absorbed into the bloodstream or
broken down in the body.
Idrolax is used for the treatment of constipation in adults and
children aged 8 years and above.
This medicine is a powder that you dissolve in a glass of water (at
least 50ml) and drink. It usually takes 24
to 48 hours to work.
The treatment of constipation with any medicine should only be in
addition to a healthy lifestyle and diet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IDROLAX
DO NOT TAKE IDROLAX:

if you are allergic (hypersensitive) to macrogol (

Summary of Product characteristics

Health Products Regulatory Authority
20 January 2022
CRN00CNQH
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
Macrogol 4000
………………………………………………………10.00g
per sachet
Excipients with known effect:
Sorbitol (E420)
………………………………………………………1.7 mg
per sachet.
Sulphur dioxide (E220)
………………………………………………0.12* 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 movements will be maintained by
lifestyle and dietary measures.
Method of administration
The content of each sachet should be dissolved in about 50 ml of water
just before use and taken in the morning. The resultant
solution will be