NORGALAX Rectal gel Ref.[27673] Active ingredients: Docusate

As with all laxatives, Norgalax should not be administered chronically. Prolonged use can precipitate the onset of an atonic non- functioning colon and hypokalaemia.

Norgalax may increase the resorption of medicines and is not to be used in combination with hepatotoxic agents.

Pregnancy

There are no adequate data from the use of docusate enema or oral docusate in pregnant women. Animal studies with oral docusate are insufficient with respect to effects on pregnancy and embryonic foetal development.

The potential risk for humans is unknown. As minimal systemic absorption cannot be ruled out following rectal application, Norgalax should be used in pregnancy only if the benefits outweigh the risks.

Lactation

It is unknown whether docusate is excreted in human breast milk. Animal studies have shown excretion of docusate and its metabolites in breast milk when administered systemically. A decision on whether to continue/discontinue breast-feeding or continue/discontinue therapy with NORGALAX should be made taking into account the benefit of breast-feeding to the child and the benefit of NORGALAX therapy to the woman.

None known.

Gastrointestinal disorders: anal burning, rectal pain, rectal bleeding, diarrhoea

Skin disorders: urticaria

Hepatic disorders: cases of hepatotoxicity have been reported with oral intake of docusate taken together with other laxatives.

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.

None known.