DULCOEASE Capsule, soft Ref.[8429] Active ingredients: Docusate

Organic disorders should be excluded prior to the administration of any laxative.

Each 100 mg capsule contains approximately 19.3 mg of sorbitol, resulting in 96.5 mg sorbitol per maximum recommended daily dose for adults. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Dulcoease 100 mg Capsules contain E110 sunset yellow which may cause allergic reactions.

Dulcoease should not be taken concurrently with mineral oil laxatives such as liquid paraffin.

Pregnancy

There are no adequate data from the use of the drug in pregnant women. The potential risk for humans is unknown.

Nonclinical studies are insufficient with respect to effects on pregnancy and fetal development. Dulcoease should be used during pregnancy only if the benefits outweigh the risks.

Lactation

Non-clinical studies have shown excretion of docusate sodium and its metabolites into breast milk when administered systemically. Dulcoease should be used with caution in nursing mothers.

Fertility

There is insufficient data on the effect of docusate sodium on fertility.

None known.

The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%; Not known (cannot be estimated from available data).

Gastrointestinal disorders

Rare: Diarrhoea, nausea, abdominal cramps

Skin and subcutaneous tissue disorders

Frequency unknown: Rash and pruritus

Reporting of suspected adverse reactions

Reporting suspected adverse reaction 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 the Google Play or Apple App Store.

Not applicable.