TRANSISOFT Powder for oral solution in sachet Ref.[49893] Active ingredients: Macrogol

Warnings

The treatment of constipation with any medicinal product is only an adjuvant to a healthy lifestyle and diet, for example:

• Increased intake of liquids and dietary fibre,
• Appropriate physical activity and rehabilitation of the bowel reflex.

In case of diarrhoea, caution should be exercised, particularly in patients who are at higher risk for water electrolyte balance disorders (e.g. the elderly, patients with impaired hepatic or renal function or patients taking diuretics) and electrolyte control should be considered.

If patients develop any symptoms indicating shifts of fluid/ electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) TRANSISOFT 8.5 g should be stopped immediately, electrolytes measured and any abnormality treated appropriately.

In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5. h3. Precautions for use

Cases of hypersensitivity reactions (rash, urticaria, oedema, anaphylactic shock) have been reported with drugs containing macrogol (polyethylene glycol).

TRANSISOFT 8.5 g powder for oral solution in sachet is sugar free so it can be prescribed to diabetic patients or patients on a galactose-free diet.

No interaction studies have been performed and data is limited. Intestinal absorption of other medicinal products may be reduced transiently with the concomitant use of TRANSISOFT 8.5 g. There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products (e.g. anti-coagulants or anti-epileptics).

TRANSISOFT 8.5 g may result in a potential interactive effect if used with starch-based food thickeners. The macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

Pregnancy

There are limited amount of data from the use of TRANSISOFT 8.5 g in pregnant women. Animal studies (rats and rabbits) do not indicate reproductive toxicity. Clinically, no effects during pregnancy are anticipated, since systemic exposure to MACROGOL 3350 is negligible. TRANSISOFT 8.5 g can be used during pregnancy.

Breast-feeding

No effects on the breast-feeding newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to MACROGOL 3350 is negligible. TRANSISOFT 8.5 g powder for oral solution in sachet can be used during breast-feeding.

Fertility

There are no data on the effects of TRANSISOFT 8.5 g on fertility in humans. However, no effects on fertility are anticipated since systemic exposure to TRANSISOFT 8.5 g is negligible. There were no effects on fertility in a study in male and female rats.

TRANSISOFT 8.5 g has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

Gastrointestinal disorders, in particular diarrhea, are the most frequent adverse reactions associated with PEG use in constipation. Other adverse effects include abdominal pain, abdominal distension, nausea, flatulence, vomiting and faecal incontinence.

Tabulated list of adverse reactions

The undesirable effects listed below have been reported during clinical trials (including 635 adult patients exposed to MACROGOL 3350) and during post-marketing use.

Adverse Drug Reactions are listed under headings of frequency using the following categories: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Description of selected adverse reactions

Diarrhoea was the single most common adverse event in all the clinical studies. Diarrhoea occurred at a rate up to 17.2% during the clinical trials. In most cases diarrhoea was mild to moderate in severity and was easily treated by dose reduction or medication withdrawal.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance Website: www.hpra.ie.

Not applicable.