Transisoft 8.5 g powder for oral solution in sachet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Macrogol 3350

Available from:

Laboratoires Mayoly Spindler

ATC code:

A06AD; A06AD15

INN (International Name):

Macrogol 3350

Dosage:

8.50 gram(s)

Pharmaceutical form:

Powder for oral solution in sachet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives; macrogol

Authorization status:

Not marketed

Authorization date:

2016-09-16

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRANSISOFT 8.5 G POWDER FOR ORAL SOLUTION IN SACHET
Macrogol 3350
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What TRANSISOFT 8.5 g is and what it is used for
2.
What you need to know before you take use TRANSISOFT 8.5 g
3.
How to take TRANSISOFT 8.5 g
4.
Possible side effects
5.
How to store TRANSISOFT 8.5 g
6.
Contents of the pack and other information
1.
WHAT TRANSISOFT 8.5 G
IS AND WHAT IT IS USED FOR
HOW IT WORKS
It belongs to a group of medicines called osmotic laxatives.This
medicine carries water to your stool, which
loosens and increases stool volume, helping to overcome sluggish
bowels. It is not absorbed into the
bloodstream or broken down in the body.
WHAT IT IS USED FOR
This medicine is used for the treatment of chronic constipation in
adults. It is not
recommended for children below 17 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRANSISOFT 8.5 G
INFORMATION ON CONSTIPATION TREATMENT
The treatment of chronic constipation with any medicine should only be
in addition to a healthy lifestyle and
diet, for example:

increase the proportion of vegetal source products in the diet
(vegetables, bread, fruits),

increase water and fruit juice intake,

increase physical activity (sports, walking…),

rehabilitation of defecation reflex.
DO NOT TAKE TRANSISOFT 8.5 G

If you are allergic (hypersensitive) to the active substance (macrogol
= P.E.G. = polyethylene glycol).

If you have s

Summary of Product characteristics

Health Products Regulatory Authority
15 February 2022
CRN00CP47
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Transisoft 8.5 g powder for oral solution in sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 8.5 g of macrogol 3350.
3 PHARMACEUTICAL FORM
Powder for oral solution in sachet.
White or almost white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Transisoft 8.5 g powder for oral solution in sachet is indicated for
the symptomatic treatment of chronic constipation in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and the elderly: 2 sachets daily.
Do not take more than 2 sachets per day.
_Paediatric population: _Not recommended in children below 17 years of
age.
_Elderly_
No dosage change is necessary for the treatment of chronic
constipation in elderly.
_In patients with renal impairment_
No dosage adjustment is required for the treatment of chronic
constipation in patients with renal impairment. (see section 5.2)
_Method of administration _
Each sachet should be dissolved in a ½ glass of water (100 mL) just
before use.
The dissolved solution remains as clear as water.
Should be taken as a single dose, preferably in the morning.
The effect of Transisoft8.5 g powder for oral solution in sachet
usually becomes apparent within 24 to 48 hours after its
administration.
An organic disorder should have been ruled out before initiation of
treatment. Transisoft8.5 g powder for oral solution in
sachet should remain a temporary adjuvant treatment to appropriate
lifestyle and dietary management of constipation. A
course of treatment for chronic constipation with Transisoft 8.5 g
does not normally exceed 2 weeks, although this can be
repeated if required. As for all laxatives, prolonged use is not
usually recommended. If symptoms persist despite associated
dietary measures, an underlying cause should be considered.
4.3 CONTRAINDICATIONS

Severe inflammatory bowel disease (such as ulcerative colitis, Crohn's
disease) or toxic megacolon,

I