Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Laboratoires Mayoly Spindler, 6 avenue de leurope BP 51, 78401 CHATOU Cedex, France
Transisoft 8.5 g powder for oral solution in sachet is indicated for the symptomatic treatment of chronic constipation in adults.
2 sachets daily.
Do not take more than 2 sachets per day.
Not recommended in children below 17 years of age.
No dosage change is necessary for the treatment of chronic constipation in elderly.
No dosage adjustment is required for the treatment of chronic constipation in patients with renal impairment (see section 5.2).
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.
Overdose leads to diarrhoea which disappears when treatment is temporarily interrupted or the dosage is reduced.
Excessive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
3 years.
Reconstituted solution: use immediately.
This medicinal product does not require any special storage conditions.
Paper/Polyethylene, Low Density/Aluminum Foil/Polyethylene, Low Density unit-dose sachet.
Pack sizes of 14 or 28 sachets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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