Co-danthrusate

Co-danthrusate Suspension

Each 5 ml containing 60 mg Sodium Docusate BP and 50 mg Dantron BP For excipients, see 6.1

Suspension

Constipation in terminally ill patients of all ages.

Adults: One to three 5ml doses at bedtime Children One 5ml dose at bedtime Method of Administration: Oral

In common with all laxatives, 'Normax' or Co-danthrusate is contraindicated in cases of non-specific abdominal pain and when intestinal obstruction is suspected.

In experimental animals, Dantron has been associated with adenocarcinomas in the bowel and tumours in the liver. A theoretical risk of similar effects in humans cannot be excluded. Dantron is excreted in the urine and metabolised dantron in the faeces. There is evidence that these may cause perineal erythema in patients with urinary and or faecal incontinence. It is recommended therefore that co-danthrusate should be used with caution in all incontinent patients. Prolonged use is not recommended.

Docusate may enhance the gastrointestinal or hepatic cell uptake of other drugs potentiating their activity and possibly increasing their toxicity.

Co-danthrusate should not be used in pregnancy or lactation.

None known.

Occasionally an orange tint in the urine may be observed due to the Dantron component. Skin rash may occur and reports of skin irritation, skin discolouration and superficial sloughing of the perianal skin have been reported after prolonged use of co-danthrusate. Melanosis coli (discolouration of the colonic mucosa) after prolonged use or high doses of Co-Danthrusate.

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.

The patient should be encouraged to drink fluids. An anticholinergic preparation may be used to ease excessive intestinal motility if necessary.

ATC Code: A06A G10 Dantron is a mild peristaltic stimulant acting on the lower bowel to encourage normal bowel movement without causing irritation. Docusate sodium is a softening agent which prevents excessive colonic dehydration and hardening of stools.

Not available.

No further information.

Methylcellulose Xanthan Gum Glycerol Propyl Parahydroxybenzoate Methyl Parahydroxybenzoate Sorbitol Powder (E200) Saccharin Sodium Disodium Hydrogen Orthophosphate (Anhydrous) Sodium Dihydrogen Orthophosphate Peppermint Oil Purified Water

Not known

36 month (200 ml) 24 month (30 ml)

Do not store above 25°C. Store in the original package.

Amber glass bottle with either roll-on pilfer proof aluminium cap with 'steran' faced wad or plastic cap with 'saranex' faced wad. The 30ml volume is for promotional purposes only. The 200ml volume is for prescription.

None.

Pinewood Laboratories LimitedBallymacarbryClonmelCo. TipperaryIreland

PL 04917/0142

18/01/2005

04/09/2015