DULCOLAX PICO Oral solution Ref.[8377] Active ingredients: Sodium picosulfate

As with all laxatives, DULCOLAX should not be taken on a continuous daily basis for more than five days without investigating the cause of constipation.

Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.

Dizziness and/or syncope have been reported in patients who have taken DULCOLAX. 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.

DULCOLAX should not be taken by children under 10 years without medical advice.

Dulcolax Pico Liquid contains 4.8 vol % ethanol (alcohol) i.e. up to 480 mg per dose, equivalent to 10.4 ml beer, 4.3 ml wine per dose.

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

Dulcolax Pico Liquid contains the preservatives methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of DULCOLAX are taken.

Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

Concurrent administration of antibiotics may reduce the laxative action of this product.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy.

Lactation

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, DULCOLAX PICO 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.

Fertility

No studies on the effect on human fertility have been conducted.

Non-clinical studies did not reveal any effect on fertility (see section 5.3).

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.

Immune system disorders

Not known: Hypersensitivity*

Nervous system disorders

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).

Gastrointestinal disorders

Very common: Diarrhoea

Common: Abdominal discomfort, abdominal pain, abdominal cramps.

Uncommon: Nausea, vomiting.

Skin and subcutaneous tissue disorders

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.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store.

None stated.