Sodium picosulfate interacts in the following cases:
The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of sodium picosulphate are taken.
Concurrent administration of antibiotics may reduce the laxative action of sodium picosulphate.
Dizziness and/or syncope have been reported in patients who have taken sodium picosulphate. The details available for these cases suggest that the events would be consistent with defaecation syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the constipation, and not necessarily to the administration of sodium picosulfate itself.
There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy.
Clinical data show that neither the active moiety of sodium picosulfate (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.
Nevertheless, as with all medicines, sodium picosulfate should not be taken in pregnancy, especially the first trimester, and during breast feeding unless the expected benefit is thought to outweigh any possible risk and only on medical advice.
No studies on the effect on human fertility have been conducted.
Non-clinical studies did not reveal any effect on fertility.
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that due to a vasovagal response (for example, due to abdominal spasm), dizziness and/or syncope may be experienced. If patients experience abdominal spasm they should avoid potentially hazardous tasks such as driving or operating machinery.
Adverse events have been ranked under headings of frequency using the following convention: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known – cannot be estimated from the available data.
Not known: Hypersensitivity*
Uncommon: Dizziness
Not known: Syncope*
Dizziness and syncope occurring after taking sodium picosulfate appear to be consistent with a vasovagal response (for example, due to abdominal spasm, defaecation).
Very common: Diarrhoea
Common: Abdominal discomfort, abdominal pain, abdominal cramps.
Uncommon: Nausea, vomiting.
Not known: Skin reactions* such as angioedema*, drug eruption*, rash*, pruritus*.
* This adverse event has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than uncommon, but might be lower. A precise frequency estimation is not possible as the adverse event did not occur in a clinical trial database of 1,020 patients.
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